Trial Outcomes & Findings for Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery. (NCT NCT03031327)

NCT ID: NCT03031327

Last Updated: 2024-12-06

Results Overview

A global ocular tolerability score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 meant no symptoms and 100 meant the worst possible discomfort. This evaluation was to be performed before any ophtalmic assessment at each scheduled visit. Specific ocular symptoms measured with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. The patients evaluated their symptoms using the VAS giving the value they were feeling from none to an extreme value. The VAS scale was a straight horizontal line of fixed length (100 mm). The ends were defined as extreme limits of the parameter.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Day 1 (baseline = Visit 1) at pre-dose, 15, 30 min post-dose; Day 15±2 (= Visit 2) at pre-dose, 15, 30 min post-dose; Day 22±2 (= Visit 3)
• Results posted on: 2024-12-06

Participant Flow

Thirty (30) patients (10 per arm) randomized 1:1:1 to Lubricin 20 μg/mL eye drops solution or Lubricin 50 μg/mL eye drops solution or sodium hyaluronate (HA) 0.18% eye drops solution were enrolled, randomised and treated. The enrolled and safety analysis sets included all 30 enrolled and treated subjects, while the full analysis set (FAS) included 29 subjects and excluded one of the 2 discontinued subjects due to major protocol deviations.

Participant milestones

Measure	Lubricin 20µg/ml Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Overall Study STARTED	10	10	10
Overall Study Full Analysis Set Population (FAS)	10	10	9
Overall Study Safety Population (SAF)	10	10	10
Overall Study Patients in Which Left Eye is the Study Eye	6	6	5
Overall Study Patients in Which Right Eye is the Study Eye	4	4	5
Overall Study COMPLETED	10	9	9
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Measure	Lubricin 20µg/ml Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Overall Study Withdrawal by Subject	0	1	1

Baseline Characteristics

Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.

Baseline characteristics by cohort

Measure	Lubricin 20µg/ml n=10 Participants Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml n=10 Participants Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate n=10 Participants Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops	Total n=30 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 14.4 • n=5 Participants	37.4 years STANDARD_DEVIATION 12.2 • n=7 Participants	39.1 years STANDARD_DEVIATION 9.7 • n=5 Participants	38.1 years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Italy	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 (baseline = Visit 1) at pre-dose, 15, 30 min post-dose; Day 15±2 (= Visit 2) at pre-dose, 15, 30 min post-dose; Day 22±2 (= Visit 3)

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). This analysis set was used for the efficacy analysis. Please note that for participants, study eye and non-study eye values were assessed and reported.

A global ocular tolerability score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 meant no symptoms and 100 meant the worst possible discomfort. This evaluation was to be performed before any ophtalmic assessment at each scheduled visit. Specific ocular symptoms measured with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. The patients evaluated their symptoms using the VAS giving the value they were feeling from none to an extreme value. The VAS scale was a straight horizontal line of fixed length (100 mm). The ends were defined as extreme limits of the parameter.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=20 eyes Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=20 eyes Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=18 eyes Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Study eye - Day 15±2 (pre-dose)	-15.5 mm Standard Deviation 18.2	-14.4 mm Standard Deviation 14.0	-6.3 mm Standard Deviation 11.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Non Study eye - Day 15±2 (pre-dose)	-12.1 mm Standard Deviation 20.6	-9.7 mm Standard Deviation 14.2	-6.2 mm Standard Deviation 8.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non Study Eye - Day 15±2 (15 min)	-7.8 mm Standard Deviation 8.7	-7.1 mm Standard Deviation 12.0	-9.7 mm Standard Deviation 7.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non Study Eye - Day 15±2 (30 min)	-6.5 mm Standard Deviation 8.8	-7.0 mm Standard Deviation 11.7	-8.2 mm Standard Deviation 7.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non Study Eye - Day 1 (15 min)	-7.9 mm Standard Deviation 11.8	-8.3 mm Standard Deviation 11.0	-13.6 mm Standard Deviation 9.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non Study Eye - Day 1 (30 min)	-7.5 mm Standard Deviation 13.2	-8.2 mm Standard Deviation 11.5	-10.4 mm Standard Deviation 9.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non Study Eye - Day 15±2 (pre-dose)	-2.8 mm Standard Deviation 14.3	-4.8 mm Standard Deviation 9.9	-4.3 mm Standard Deviation 3.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non Study Eye - Day 15±2 (15 min)	-7.0 mm Standard Deviation 14.3	-7.7 mm Standard Deviation 11.6	-9.1 mm Standard Deviation 7.5
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non Study Eye - Day 15±2 (30 min)	-8.1 mm Standard Deviation 14.8	-7.2 mm Standard Deviation 10.4	-9.1 mm Standard Deviation 9.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non Study Eye - Day 22±2	-3.5 mm Standard Deviation 16.4	-2.1 mm Standard Deviation 3.1	-3.4 mm Standard Deviation 7.4
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study Eye - Day 1 (15 min)	-10.5 mm Standard Deviation 8.6	-11.6 mm Standard Deviation 15.2	-11.9 mm Standard Deviation 7.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study Eye - Day 1 (30 min)	-8.9 mm Standard Deviation 6.4	-10.1 mm Standard Deviation 15.5	-11.0 mm Standard Deviation 10.2
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study Eye - Day 15 (pre-dose)	-13.7 mm Standard Deviation 12.6	-7.1 mm Standard Deviation 12.9	-5.4 mm Standard Deviation 3.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study Eye - Day 15±2 (15 min)	-15.9 mm Standard Deviation 12.1	-11.9 mm Standard Deviation 17.2	-11.0 mm Standard Deviation 6.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study Eye - Day 15±2 (30 min)	-14.3 mm Standard Deviation 13.1	-14.2 mm Standard Deviation 17.8	-9.4 mm Standard Deviation 7.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study Eye - Day 22±2	-8.3 mm Standard Deviation 13.8	-5.2 mm Standard Deviation 11.8	-0.6 mm Standard Deviation 7.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non Study Eye - Day 1 (15 min)	-11.1 mm Standard Deviation 13.3	-4.9 mm Standard Deviation 6.7	-10.0 mm Standard Deviation 8.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non Study Eye - Day 1 (30 min)	-10.2 mm Standard Deviation 13.8	-4.0 mm Standard Deviation 9.1	-10.0 mm Standard Deviation 9.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non Study Eye - Day 15±2 (pre-dose)	-4.6 mm Standard Deviation 9.0	-3.8 mm Standard Deviation 11.6	-3.8 mm Standard Deviation 3.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non Study Eye - Day 22±2	-4.4 mm Standard Deviation 9.7	-2.1 mm Standard Deviation 9.3	0.9 mm Standard Deviation 7.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Study Eye - Day 1 (15 min)	-7.3 mm Standard Deviation 18.4	-21.4 mm Standard Deviation 16.3	-18.7 mm Standard Deviation 13.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Study Eye - Day 1 (30 min)	-7.7 mm Standard Deviation 18.6	-22.3 mm Standard Deviation 18.2	-16.1 mm Standard Deviation 10.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Study Eye - Day 15±2 (pre-dose)	-12.6 mm Standard Deviation 13.7	-15.2 mm Standard Deviation 24.4	-9.6 mm Standard Deviation 9.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Study Eye - Day 15±2 (15 min)	-14.6 mm Standard Deviation 13.0	-24.4 mm Standard Deviation 27.2	-17.4 mm Standard Deviation 12.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Study Eye - Day 15±2 (30 min)	-12.8 mm Standard Deviation 13.1	-25.3 mm Standard Deviation 24.8	-14.8 mm Standard Deviation 11.2
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Study Eye - Day 22±2	-8.7 mm Standard Deviation 12.0	-5.7 mm Standard Deviation 8.8	-1.0 mm Standard Deviation 7.0
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Non Study Eye - Day 1 (15 min)	-14.0 mm Standard Deviation 12.1	-15.5 mm Standard Deviation 13.8	-19.9 mm Standard Deviation 13.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Study eye - Day 1 (15 min)	-22.8 mm Standard Deviation 13.2	-30.1 mm Standard Deviation 15.4	-20.9 mm Standard Deviation 14.2
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Study eye - Day 1 (30 min)	-20.9 mm Standard Deviation 13.3	-29.3 mm Standard Deviation 18.6	-19.6 mm Standard Deviation 11.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Study eye - Day 15±2 (pre-dose)	-17.6 mm Standard Deviation 17.0	-17.3 mm Standard Deviation 20.0	-14.2 mm Standard Deviation 12.2
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Study eye - Day 15±2 (15 min)	-25.9 mm Standard Deviation 15.4	-33.3 mm Standard Deviation 25.7	-22.7 mm Standard Deviation 10.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Study eye - Day 15±2 (30 min)	-22.5 mm Standard Deviation 15.1	-29.8 mm Standard Deviation 25.0	-19.7 mm Standard Deviation 10.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Study eye - Day 22±2	-5.9 mm Standard Deviation 12.4	-8.1 mm Standard Deviation 6.4	-4.4 mm Standard Deviation 9.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Non Study eye - Day 1 (15 min)	-18.7 mm Standard Deviation 12.4	-23.3 mm Standard Deviation 18.4	-22.7 mm Standard Deviation 10.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Non Study eye - Day 1 (30 min)	-18.4 mm Standard Deviation 12.9	-23.6 mm Standard Deviation 20.8	-19.7 mm Standard Deviation 10.4
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Non Study eye - Day 15±2 (pre-dose)	-10.8 mm Standard Deviation 15.7	-12.0 mm Standard Deviation 19.1	-10.2 mm Standard Deviation 12.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Non Study eye - Day 15±2 (15 min)	-19.5 mm Standard Deviation 15.0	-25.3 mm Standard Deviation 25.2	-22.2 mm Standard Deviation 12.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Non Study eye - Day 15±2 (30 min)	-17.2 mm Standard Deviation 15.7	-23.1 mm Standard Deviation 25.3	-17.8 mm Standard Deviation 11.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Dryness - Non Study eye - Day 22±2	-7.2 mm Standard Deviation 15.9	-3.6 mm Standard Deviation 3.3	-4.4 mm Standard Deviation 8.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Study eye - Day 1 (15 min)	-10.9 mm Standard Deviation 20.0	-28.1 mm Standard Deviation 19.2	-19.8 mm Standard Deviation 11.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Study eye - Day 1 (30 min)	-8.2 mm Standard Deviation 20.7	-24.0 mm Standard Deviation 24.3	-18.2 mm Standard Deviation 9.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Study eye - Day 15±2 (pre-dose)	-12.7 mm Standard Deviation 15.3	-15.3 mm Standard Deviation 20.7	-10.7 mm Standard Deviation 9.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Study eye - Day 15±2 (15 min)	-16.9 mm Standard Deviation 17.9	-27.8 mm Standard Deviation 24.0	-19.2 mm Standard Deviation 11.2
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Study eye - Day 15±2 (30 min)	-16.7 mm Standard Deviation 17.6	-23.7 mm Standard Deviation 24.1	-16.7 mm Standard Deviation 9.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Study eye - Day 22±2	-5.5 mm Standard Deviation 12.8	-6.1 mm Standard Deviation 8.6	-1.4 mm Standard Deviation 5.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Non Study eye - Day 1 (15 min)	-16.1 mm Standard Deviation 12.6	-19.1 mm Standard Deviation 19.6	-22.1 mm Standard Deviation 15.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Non Study eye - Day 1 (30 min)	-12.5 mm Standard Deviation 13.0	-20.6 mm Standard Deviation 25.2	-18.9 mm Standard Deviation 15.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Non Study eye - Day 15±2 (pre-dose)	-5.6 mm Standard Deviation 21.6	-8.2 mm Standard Deviation 17.9	-11.0 mm Standard Deviation 15.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Non Study eye - Day 15±2 (15 min)	-8.8 mm Standard Deviation 35.4	-16.8 mm Standard Deviation 26.7	-20.7 mm Standard Deviation 17.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Non Study eye - Day 15±2 (30 min)	-6.0 mm Standard Deviation 33.6	-15.7 mm Standard Deviation 27.1	-18.6 mm Standard Deviation 16.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign body sensation - Non Study eye - Day 22±2	-1.2 mm Standard Deviation 21.1	-5.1 mm Standard Deviation 4.5	-2.1 mm Standard Deviation 6.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Study eye - Day 1 (15 min)	-11.7 mm Standard Deviation 10.6	-23.1 mm Standard Deviation 17.2	-18.9 mm Standard Deviation 14.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Study eye - Day 1 (30 min)	-10.9 mm Standard Deviation 11.3	-20.4 mm Standard Deviation 18.5	-19.0 mm Standard Deviation 15.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Study eye - Day 15±2 (15 min)	-18.3 mm Standard Deviation 17.2	-28.4 mm Standard Deviation 17.5	-18.7 mm Standard Deviation 12.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Study eye - Day 15±2 (30 min)	-16.0 mm Standard Deviation 16.7	-27.1 mm Standard Deviation 18.2	-13.8 mm Standard Deviation 8.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Study eye - Day 22±2	-10.9 mm Standard Deviation 17.4	-9.1 mm Standard Deviation 9.3	-3.3 mm Standard Deviation 5.2
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Non Study eye - Day 1 (15 min)	-18.9 mm Standard Deviation 14.0	-17.5 mm Standard Deviation 20.1	-19.2 mm Standard Deviation 9.4
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Non Study eye - Day 1 (30 min)	-15.4 mm Standard Deviation 14.0	-16.8 mm Standard Deviation 21.3	-6.2 mm Standard Deviation 8.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Non Study eye - Day 15±2 (15 min)	-18.6 mm Standard Deviation 17.3	-18.3 mm Standard Deviation 21.5	-15.8 mm Standard Deviation 9.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Non Study eye - Day 15±2 (30 min)	-13.2 mm Standard Deviation 15.3	-16.1 mm Standard Deviation 23.4	-13.1 mm Standard Deviation 9.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Non Study eye - Day 22±2	-9.4 mm Standard Deviation 21.3	-4.8 mm Standard Deviation 7.9	-0.2 mm Standard Deviation 4.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study Eye - Day 1 (15 min)	-9.0 mm Standard Deviation 13.7	-8.9 mm Standard Deviation 11.8	-13.0 mm Standard Deviation 14.2
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study Eye - Day 1 (30 min)	-9.2 mm Standard Deviation 17.4	-8.3 mm Standard Deviation 11.5	-10.9 mm Standard Deviation 12.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Non Study Eye - Day 1 (30 min)	-12.8 mm Standard Deviation 12.0	-16.3 mm Standard Deviation 16.5	-18.1 mm Standard Deviation 12.4
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Non Study Eye - Day 15±2 (pre-dose)	-5.8 mm Standard Deviation 9.8	-12.4 mm Standard Deviation 20.8	-10.2 mm Standard Deviation 10.4
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Non Study Eye - Day 15±2 (15 min)	-4.6 mm Standard Deviation 16.5	-19.9 mm Standard Deviation 23.8	-18.9 mm Standard Deviation 13.2
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Non Study Eye - Day 15±2 (30 min)	-5.7 mm Standard Deviation 11.7	-18.1 mm Standard Deviation 20.6	-16.0 mm Standard Deviation 12.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Non Study Eye - Day 22±2	-5.0 mm Standard Deviation 10.7	-3.7 mm Standard Deviation 6.5	-2.1 mm Standard Deviation 5.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Study Eye - Day 1 (15 min)	-8.0 mm Standard Deviation 9.7	-14.2 mm Standard Deviation 20.2	-11.0 mm Standard Deviation 12.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Study Eye - Day 1 (30 min)	-6.3 mm Standard Deviation 9.0	-14.9 mm Standard Deviation 22.4	-8.8 mm Standard Deviation 11.9
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Study Eye - Day 15±2 (pre-dose)	-6.0 mm Standard Deviation 7.8	-13.9 mm Standard Deviation 24.5	-4.1 mm Standard Deviation 5.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Study Eye - Day 15±2 (15 min)	-11.6 mm Standard Deviation 10.5	-18.4 mm Standard Deviation 25.5	-8.7 mm Standard Deviation 8.0
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Study Eye - Day 15±2 (30 min)	-10.0 mm Standard Deviation 10.2	-18.2 mm Standard Deviation 25.4	-5.2 mm Standard Deviation 6.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Study Eye - Day 22±2	-3.4 mm Standard Deviation 6.2	-5.6 mm Standard Deviation 8.4	-1.0 mm Standard Deviation 7.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Non Study Eye - Day 1 (15 min)	-3.8 mm Standard Deviation 6.1	-10.7 mm Standard Deviation 10.8	-9.7 mm Standard Deviation 11.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Non Study Eye - Day 1 (30 min)	-4.8 mm Standard Deviation 7.2	-10.1 mm Standard Deviation 15.0	-8.3 mm Standard Deviation 10.4
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Non Study Eye - Day 15±2 (pre-dose)	-1.8 mm Standard Deviation 4.3	-11.9 mm Standard Deviation 16.1	-4.8 mm Standard Deviation 4.0
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Non Study Eye - Day 15±2 (15 min)	-4.8 mm Standard Deviation 6.4	-15.8 mm Standard Deviation 19.9	-8.6 mm Standard Deviation 6.5
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Non Study Eye - Day 15±2 (30 min)	-4.2 mm Standard Deviation 7.0	-14.3 mm Standard Deviation 20.8	-5.0 mm Standard Deviation 6.0
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Non Study Eye - Day 22±2	-0.7 mm Standard Deviation 6.1	-3.6 mm Standard Deviation 4.9	-1.3 mm Standard Deviation 6.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study Eye - Day 1 (15 min)	-16.5 mm Standard Deviation 16.2	-23.4 mm Standard Deviation 24.3	-24.2 mm Standard Deviation 14.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study Eye - Day 1 (30 min)	-14.8 mm Standard Deviation 14.7	-21.5 mm Standard Deviation 27.0	-23.2 mm Standard Deviation 12.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study Eye - Day 15±2 (pre-dose)	-11.6 mm Standard Deviation 16.3	-15.6 mm Standard Deviation 29.5	-13.3 mm Standard Deviation 10.6
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study Eye - Day 15±2 (15 min)	-18.3 mm Standard Deviation 15.2	-25.4 mm Standard Deviation 31.0	-23.7 mm Standard Deviation 12.5
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study Eye - Day 15±2 (30 min)	-16.4 mm Standard Deviation 15.5	-25.7 mm Standard Deviation 30.0	-17.8 mm Standard Deviation 9.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study Eye - Day 15±2 (pre-dose)	-8.1 mm Standard Deviation 18.8	-3.7 mm Standard Deviation 7.1	-6.6 mm Standard Deviation 6.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study Eye - Day 15±2 (15 min)	-14.0 mm Standard Deviation 20.1	-7.2 mm Standard Deviation 10.4	-13.1 mm Standard Deviation 13.0
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study Eye - Day 22±2	-3.3 mm Standard Deviation 6.5	-6.2 mm Standard Deviation 10.7	-7.0 mm Standard Deviation 13.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non Study Eye - Day 1 (15 min)	-13.4 mm Standard Deviation 11.8	-20.7 mm Standard Deviation 24.8	-18.7 mm Standard Deviation 16.1
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non Study Eye - Day 1 (30 min)	-12.2 mm Standard Deviation 10.4	-20.0 mm Standard Deviation 27.1	-16.4 mm Standard Deviation 13.3
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study Eye - Day 15±2 (30 min)	-11.5 mm Standard Deviation 18.8	-6.9 mm Standard Deviation 10.6	-7.7 mm Standard Deviation 8.7
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non Study Eye - Day 15±2 (pre-dose)	-2.5 mm Standard Deviation 6.3	-14.2 mm Standard Deviation 29.2	-14.4 mm Standard Deviation 9.4
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non Study Eye - Day 15±2 (15 min)	-11.6 mm Standard Deviation 10.3	-16.7 mm Standard Deviation 31.3	-18.2 mm Standard Deviation 13.5
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non Study Eye - Day 15±2 (30 min)	-9.8 mm Standard Deviation 10.5	-16.3 mm Standard Deviation 29.3	-15.8 mm Standard Deviation 10.4
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non Study Eye - Day 22±2	-0.5 mm Standard Deviation 5.8	-4.8 mm Standard Deviation 10.2	-5.4 mm Standard Deviation 11.8
Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study Eye - Day 22±2	-7.2 mm Standard Deviation 20.6	-2.2 mm Standard Deviation 6.0	-3.4 mm Standard Deviation 7.8

PRIMARY outcome

Timeframe: From baseline (Day 1 - pre-dose) to day 22±2

Population: The Safety population (SAF) included all patients who received and used at least once the IMDs (Lubricin or Vismed ®).

TEAEs included all AEs occurring or worsening after the first dose of IMD. These comprise AEs during the treatment and follow-up period. For TEAE, the number of events was provided.

At each visit (Visit 1 which took place at Day 1; Visit 2 which took place at day 15 ± 2; Visit 3, i.e. final visi FU, at Day 22 ± 2/ETV), patients could spontaneously report any physical or medical occurrence and the investigator or designee inquired about the occurrence of TEAEs by asking specific questions. Any untoward (unfavorable & unintended) change in subject's medical conditions was to be reported as an AE. Changes in any protocol-specific ocular or systemic parameter evaluated during the study were to be reviewed by the investigator. In addition, each patient's response to any questionnaire was to be reviewed by the investigator. Any untoward (unfavorable and unintended) change in a protocol-specific parameter or questionnaire response clinically relevant was to be reported as an AE.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=10 Participants Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=10 Participants Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=10 Participants Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Treatment-emergent Adverse Events (TEAEs) Assessed Throughout the Study	0 events	0 events	0 events

SECONDARY outcome

Timeframe: Day 15±2 (Visit 2); Day 22±2 (Visit 3)

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported.

The corneal fluorescein staining was graded by using the Oxford scheme to assess cornea and conjunctiva epithelium damage. It was performed after instillation of sodium fluoresce into the inferior conjunctival cul-de-sac of each eye with the aid of a slit lamp at 10X magnification using cobalt blue illumination.

The Oxford scale grading divides corneal staining into six groups for each panel, based on the severity [from 0 (absent) to 5 (severe)]. The corneal staining is represented by punctate dots on a series of panels (panel A=grade 0 to panel >E=grade 5). Staining ranges from 0-5 for each panel, and 0-15 for the total exposed inter-palpebral conjunctiva and cornea.

The examiner selected the appropriate grade that best represented the state of corneal staining intuitional. The higher the grade, the worst is the overall outcome value.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=20 eyes Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=20 eyes Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=18 eyes Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Change From Baseline in Ocular Surface Vital Staining With Fluorescein (Oxford Scale) Study eye - Day 15±2	-0.3 score on a scale Standard Deviation 0.5	-0.7 score on a scale Standard Deviation 0.5	-0.6 score on a scale Standard Deviation 0.5
Change From Baseline in Ocular Surface Vital Staining With Fluorescein (Oxford Scale) Study eye - Day 22±2	-0.3 score on a scale Standard Deviation 0.5	-0.6 score on a scale Standard Deviation 0.5	-0.2 score on a scale Standard Deviation 0.4
Change From Baseline in Ocular Surface Vital Staining With Fluorescein (Oxford Scale) Non Study eye - Day 15±2	-0.3 score on a scale Standard Deviation 0.5	-0.3 score on a scale Standard Deviation 0.5	0 score on a scale Standard Deviation 0
Change From Baseline in Ocular Surface Vital Staining With Fluorescein (Oxford Scale) Non Study eye - Day 22±2	-0.1 score on a scale Standard Deviation 0.3	-0.1 score on a scale Standard Deviation 0.3	0 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Day 15±2 (Visit 2); Day 22±2 (Visit 3)

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported.

The Schirmer test Type I (without anaesthesia) was performed to measure aqueous tear secretion prior to the instillation of any dilating or anaesthetic eye drops. The rounded bent end of a sterile strip was inserted into the lower conjunctival sac over the temporal one-third of the lower eyelid margin. After 5 minutes had elapsed, the Schirmer's test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). The longer the wetted length, the healthier the status of the eye.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=20 eyes Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=20 eyes Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=18 eyes Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Change From Baseline in Schirmer-I Test (Without Anaesthesia) Non Study eye - Day 22±2	0.0 mm/5min Standard Deviation 0.7	-0.7 mm/5min Standard Deviation 0.7	-0.2 mm/5min Standard Deviation 1.1
Change From Baseline in Schirmer-I Test (Without Anaesthesia) Study eye - Day 15±2	0.7 mm/5min Standard Deviation 0.5	0.3 mm/5min Standard Deviation 0.7	0.6 mm/5min Standard Deviation 0.5
Change From Baseline in Schirmer-I Test (Without Anaesthesia) Study eye - Day 22±2	0.4 mm/5min Standard Deviation 1.0	0.1 mm/5min Standard Deviation 0.8	0.2 mm/5min Standard Deviation 1.6
Change From Baseline in Schirmer-I Test (Without Anaesthesia) Non Study eye - Day 15±2	0.4 mm/5min Standard Deviation 0.5	-0.2 mm/5min Standard Deviation 1.1	-0.1 mm/5min Standard Deviation 0.6

SECONDARY outcome

Timeframe: Day 15±2 (Visit 2); Day 22±2 (Visit 3)

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported.

TFBUT was measured by determining the time to tear break-up. The TFBUT test was performed after instillation of 5 μl of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit lamp at 10X magnification using cobalt blue illumination, the examiner monitored the integrity of the tear film, noting the time it took to form lacunae (clear spaces in the tear film) from the time that the eye was opened after the last blink. This measurement was performed within 10 seconds maximum. The TFBUT was measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differed by more than 2 seconds, a third reading was taken. The TFBUT value was the average of the 2 or 3 measurements. Generally, a TFBUT value of 10-35 seconds was considered normal. A value of less than 10 seconds was usually suspicious and may indicate tear film instability. The higher the value, the better the outcome.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=20 eyes Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=20 eyes Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=18 eyes Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Study eye - Day 15±2	0.9 seconds Standard Deviation 0.7	0.9 seconds Standard Deviation 0.6	0.8 seconds Standard Deviation 0.8
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Study eye - Day 22±2	0.9 seconds Standard Deviation 0.9	0.9 seconds Standard Deviation 0.6	0.4 seconds Standard Deviation 0.7
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Non Study eye - Day 15±2	0.2 seconds Standard Deviation 0.8	0.6 seconds Standard Deviation 0.7	0.0 seconds Standard Deviation 0.7
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Non Study eye - Day 22±2	0.2 seconds Standard Deviation 0.8	0.4 seconds Standard Deviation 1.7	-0.2 seconds Standard Deviation 0.7

SECONDARY outcome

Timeframe: Day 15±2 (Visit 2); Day 22±2 (Visit 3)

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported.

Best corrected visual acuity (BCDVA) was determined by careful refraction according to the standard protocol for refraction. Chart 1 was used for testing the VA of the right eye; Chart 2 for the left eye; and Chart R for refraction only. Retroilluminated standard Early Treatment of Diabetic Retinopathy Study (ETDRS) charts were used. They had 5 Sloan letters on each line of equal difficulty, and there was a geometric progression in letter size from line to line. VAS awarded one point for every letter correctly guessed. A distance of 4 meters was required between the subject's eyes and the VA chart. When a subject cannot read at least 20 letters on the chart at 4 meters, the subject was tested at 1 meter. If 20 or more letters were read at 4 meters, the VAS for that eye was recorded as the number of letters correct at 4 meters plus 30. Otherwise, the VAS was the number of letters read correctly at 1 meter plus the number read at 4 meters. The higher the score the better the outcome.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=20 eyes Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=20 eyes Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=18 eyes Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Study eye - Day 15±2	0.4 score on a scale Standard Deviation 0.7	0.4 score on a scale Standard Deviation 0.5	0.3 score on a scale Standard Deviation 0.5
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Study eye - Day 22±2	0.1 score on a scale Standard Deviation 0.6	0.4 score on a scale Standard Deviation 1.5	0.0 score on a scale Standard Deviation 1.7
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Non Study eye - Day 15±2	-0.1 score on a scale Standard Deviation 0.9	0.2 score on a scale Standard Deviation 0.4	-0.1 score on a scale Standard Deviation 0.6
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Non Study eye - day 22±2	-0.1 score on a scale Standard Deviation 0.6	0.1 score on a scale Standard Deviation 0.6	-0.2 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Day 15±2 (Visit 2); Day 22±2 (Visit 3)

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®).

The SANDE (Symptom Assessment in Dry Eye) questionnaire was a short questionnaire to evaluate both dry eye frequency and severity by using a 100 mm VAS. The subject symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assess both severity and frequency of symptoms. For the assessment, the subjects marked on the 100 mm VAS line the point that they felt represented their perception of their current state. The VAS score was determined by measuring in millimeters from the left hand end of the line to the point that the subject marked. The SANDE scores was then evaluated for the 2 questions severity (0-100) and frequency (0-100), where 0 was the best condition and 100 marked the worst condition.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=10 Participants Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=10 Participants Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=9 Participants Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Change From Baseline in SANDE (Symptom Assessment in Dry Eye) Questionnaire Scores Frequency of Symptoms - Day 15±2	-14.6 mm Standard Deviation 12.9	-17.6 mm Standard Deviation 15.0	-7.7 mm Standard Deviation 4.4
Change From Baseline in SANDE (Symptom Assessment in Dry Eye) Questionnaire Scores Frequency of Symptoms - Day 22±2	-11.9 mm Standard Deviation 9.8	-11.9 mm Standard Deviation 7.4	-2.7 mm Standard Deviation 6.9
Change From Baseline in SANDE (Symptom Assessment in Dry Eye) Questionnaire Scores Severity of Symptoms - Day 15±2	-11.2 mm Standard Deviation 11.2	-15.0 mm Standard Deviation 12.9	-7.1 mm Standard Deviation 4.5
Change From Baseline in SANDE (Symptom Assessment in Dry Eye) Questionnaire Scores Severity of Symptoms - Day 22±2	-7.4 mm Standard Deviation 10.7	-7.2 mm Standard Deviation 10.5	-2.7 mm Standard Deviation 4.1

SECONDARY outcome

Timeframe: Day 15±2 (Visit 2); Day 22±2 (Visit 3)

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported.

The Slit Lamp Examination was used to examine the structures of the eye (eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber) according to different scales: Eyelid - Meibomian glands (from 0-none to 3-severe), Eyelid - Erythema (from 0-none to 4-very severe), Eyelid - Oedema (from 0-none to 4-very severe), Lashes (0-normal 1-abnormal), Conjunctiva - Erythema (from 0-none to 3-severe), Conjunctiva - Oedema (from 0-none to 4-very severe), Lens (to 0-no opacification to 3-severe opacification), Iris (0-normal 1-abnormal), Anterior chamber inflammation (from 0-none to 3-severe), Cornea transparency (from 0-completely transparent to 4-complete cornea opacity), Cornea neovascularization (0-absence of vascularization to 4- neovascularization between 270° and 360°). The higher the score the worse the outcome. There was not a total score.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=20 eyes Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=20 eyes Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=18 eyes Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea neovascularization (Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea neovascularization (Non Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Meibomian glands (Study eye) - Day 15±2	-0.1 score on a scale Standard Deviation 0.3	-0.1 score on a scale Standard Deviation 0.3	-0.1 score on a scale Standard Deviation 0.3
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Meibomian glands ( Non Study eye) - Day15±2	-0.1 score on a scale Standard Deviation 0.3	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Meibomian glands (Study eye) - Day 22±2	-0.1 score on a scale Standard Deviation 0.3	-0.1 score on a scale Standard Deviation 0.3	-0.2 score on a scale Standard Deviation 0.4
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Meibomian glands (Non Study eye) - Day 22±2	-0.1 score on a scale Standard Deviation 0.3	-0.1 score on a scale Standard Deviation 0.3	-0.1 score on a scale Standard Deviation 0.3
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid erythema (Study eye) - Day 15±2	-0.1 score on a scale Standard Deviation 0.3	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid erythema (Non Study eye) - Day 15±2	-0.1 score on a scale Standard Deviation 0.3	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid erythema (Study eye) - Day 22±2	-0.1 score on a scale Standard Deviation 0.3	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid erythema (Non Study eye) - Day 22±2	-0.1 score on a scale Standard Deviation 0.3	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid Oedema (Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid Oedema (Non Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid Oedema (Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid Oedema (Non Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Lashes (Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Lashes (Non Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Lashes (Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Lashes (Non Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - erythema (Study eye) - Day 15±2	-0.1 score on a scale Standard Deviation 0.3	-0.2 score on a scale Standard Deviation 0.4	-0.3 score on a scale Standard Deviation 0.5
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - erythema (Non Study eye) - Day 15±2	-0.1 score on a scale Standard Deviation 0.3	-0.4 score on a scale Standard Deviation 0.5	0.1 score on a scale Standard Deviation 0.3
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - erythema (Study eye) - Day 22±2	-0.1 score on a scale Standard Deviation 0.3	0.0 score on a scale Standard Deviation 0.5	0.1 score on a scale Standard Deviation 0.6
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - erythema (Non Study eye) - Day 22±2	-0.1 score on a scale Standard Deviation 0.3	-0.1 score on a scale Standard Deviation 0.3	0.2 score on a scale Standard Deviation 0.4
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - oedema (Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - oedema (Non Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - oedema (Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - oedema (Non Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Lens (Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Lens (Non Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Lens (Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Lens (Non Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Iris (Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Iris (Non Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Iris (Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Iris (Non Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Anterior chamber inflammation (Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Anterior chamber inflammation (Non Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Anterior chamber inflammation (Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Anterior chamber inflammation (Non Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea transparency (Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea transparency (Non Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea transparency (Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea transparency (Non Study eye) - Day 22±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea neovascularization (Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea neovascularization (Non Study eye) - Day 15±2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: Day 15±2 (Visit 2); Day 22±2 (Visit 3)

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported.

The IOP (intraocular pressure) of the eye was determined by the balance between the amount of aqueous humor that the eye marked and ease with which it leaved the eye. IOP was performed using Goldmann applanation tonometry after the instillation of a topical anaesthetic. The Goldmann applanation tonometer measured the force necessary to flatten a corneal area of 3.06 mm diameter. At this diameter, the resistance of the cornea to flattening was counterbalanced by the capillary attraction of the tear film meniscus for the tonometer head. The IOP (in mm Hg) equals the flattening force (in grams) multiplied by 10. IOP was measured in both eyes after completion of all SLEs to avoid potential interference with the other evaluations. Both eyes were tested. Normal eye pressure was between 10 to 21 mmHg. High ocular pressure was greater than 21 mmHg.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=20 eyes Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=20 eyes Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=18 eyes Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Change From Baseline in IOP (Intraocular Pressure) Study eye - Day 15±2	0.2 mmHg Standard Deviation 1.9	-0.3 mmHg Standard Deviation 2.3	0.8 mmHg Standard Deviation 1.4
Change From Baseline in IOP (Intraocular Pressure) Non study eye - Day 15±2	0.1 mmHg Standard Deviation 0.7	0.6 mmHg Standard Deviation 2.0	0.7 mmHg Standard Deviation 1.7
Change From Baseline in IOP (Intraocular Pressure) Study eye - Day 22±2	-0.5 mmHg Standard Deviation 2.0	-0.6 mmHg Standard Deviation 2.6	-1.7 mmHg Standard Deviation 3.9
Change From Baseline in IOP (Intraocular Pressure) Non Study eye - Day 22±2	-0.9 mmHg Standard Deviation 1.6	1.4 mmHg Standard Deviation 3.0	-1.3 mmHg Standard Deviation 1.8

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 15±2 and Day 22±2

Population: The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®).

The Cochet-Bonnet aesthesiometer contained a thin, retractable, nylon monofilament that extended up to 6 cm in length. Variable pressure could be applied to the cornea by adjusting the monofilament length. The monofilament length ranged from 6 to 0.5 cm. As the monofilament length was decreased the pressure increased from 11 mm/gm to 200 mm/gm. Corneal sensation was measured in the affected eye(s) in the central area of the cornea using a Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The length of the filament in cm at which the patient corneal sensation was observed for the tested area of the cornea was reported. With decreasing length of monofilament, the corneal touch threshold increased and the corneal sensitivity decreased. Therefore, decreasing the length of monofilament was proportional to decreased corneal sensitivity.

Outcome measures

Measure	Lubricin 20µg/ml (FAS) n=20 eyes Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops	Lubricin 50µg/ml (FAS) n=20 eyes Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops	Sodium Hyaluronate (FAS) n=18 eyes Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops
Change From Baseline in Corneal Sensitivity by Cochet-Bonnet Aesthesiometry Study eye - Day 15±2	0.1 cm Standard Deviation 0.3	0.0 cm Standard Deviation 0.0	0.0 cm Standard Deviation 0.0
Change From Baseline in Corneal Sensitivity by Cochet-Bonnet Aesthesiometry Non Study eye - Day 15±2	0.0 cm Standard Deviation 0.0	0.0 cm Standard Deviation 0.0	-0.1 cm Standard Deviation 0.3
Change From Baseline in Corneal Sensitivity by Cochet-Bonnet Aesthesiometry Study eye - Day 22±2	0.0 cm Standard Deviation 0.0	0.0 cm Standard Deviation 0.0	0.0 cm Standard Deviation 0.0
Change From Baseline in Corneal Sensitivity by Cochet-Bonnet Aesthesiometry Non Study eye - Day 22±2	0.0 cm Standard Deviation 0.0	0.0 cm Standard Deviation 0.0	-0.2 cm Standard Deviation 0.4

Adverse Events

Lubricin 20µg/ml (SAF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lubricin 50µg/ml (SAF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sodium Hyaluronate 0.18% (SAF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Development & Operations

Dompé Farmaceutici SpA

Phone: +39 02 583831

Email: clinical.trials@dompe.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place