Trial Outcomes & Findings for Tolerability, Safety and Efficacy of Lubricin vs Sodium Hyaluronate Eye Drops in Subjects With Moderate Dry Eye (NCT NCT02510235)

Last Updated: 2025-02-26

Results Overview

The SANDE (Symptom Assessment in Dry Eye) questionnaire was used to evaluate both dry eye frequency and severity using a 100 mm VAS line, representing ocular dryness and/or irritation at subject's level, according to their own perception, irrespective of the eye being or not the study eye, as per study Protocol. SANDE scores ranged from 0 (best condition) to 100 (worst condition) for both severity and frequency. The VAS score was determined - in millimeters - by measuring from the left-hand end to the marked point on the VAS line. SANDE OVERALL VAS score was calculated considering the mean and the SD of the "Change from Baseline" values at Day 14±2, Day 28±4 and Day 31-41, both for frequency and severity, and then calculated as square-root of the product of the two item score. Results are reported at the patient level, rather than focusing on a single eye, as the SANDE score assesses overall dry eye symptoms rather than eye-specific effects, as per study protocol.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

Results posted on

2025-02-26

Participant Flow

Recruitment was competitive between the study sites and continued until the planned number of randomised patients was achieved. Competitive recruitment was chosen to increase the speed of recruitment and to account for any difference in enrolment rate between study sites.

Fifty-nine (59) subjects were screened and all of them were eligible for the investigation. Three (3) of the eligible subjects were not randomised and did not receive any treatment. So Fifty-six (56) subjects were randomised 1: 1 to Lubricin or Sodium Hyaluronate and used their assigned IMD at least once.

Participant milestones

Participant milestones
Measure	Lubricin Lubricin 150 µg/ml eye drops. The test investigational device, as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	OcuYal® OcuYal® is sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Overall Study STARTED	27	29
Overall Study Per-Protocol Population (PP)	24	27
Overall Study COMPLETED	26	29
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lubricin Lubricin 150 µg/ml eye drops. The test investigational device, as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	OcuYal® OcuYal® is sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lubricin n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device, as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops	Total n=51 Participants Total of all reporting groups
Age, Categorical PP population · <=18 years	0 Participants n=5 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.	0 Participants n=7 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.	0 Participants n=5 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.
Age, Categorical PP population · Between 18 and 65 years	18 Participants n=5 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.	17 Participants n=7 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.	35 Participants n=5 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.
Age, Categorical PP population · >=65 years	6 Participants n=5 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.	10 Participants n=7 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.	16 Participants n=5 Participants • Fifty-six (56) subjects were randomised and used their assigned IMD at least once. Fifty-five (55) of the 56 enrolled subjects completed the investigation per protocol, while one subject prematurely withdrew consent to the participation in the investigation.
Age, Continuous PP population	57.6 years STANDARD_DEVIATION 10.6 • n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	57.7 years STANDARD_DEVIATION 12.9 • n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	57.7 years STANDARD_DEVIATION 11.7 • n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Sex: Female, Male PP population · Female	18 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	24 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	42 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Sex: Female, Male PP population · Male	6 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	3 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	9 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Race (NIH/OMB) PP population · American Indian or Alaska Native	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Race (NIH/OMB) PP population · Asian	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Race (NIH/OMB) PP population · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Race (NIH/OMB) PP population · Black or African American	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Race (NIH/OMB) PP population · White	24 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	27 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	51 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Race (NIH/OMB) PP population · More than one race	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Race (NIH/OMB) PP population · Unknown or Not Reported	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=7 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.	0 Participants n=5 Participants • All 56 randomised subjects were included in the safety analysis set. Fifty-five (55) out of 56 safety set subjects were included in the full analysis set (FAS). The per protocol set included 51 subjects.
Region of Enrollment Italy	24 participants n=5 Participants	27 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.

Outcome measures

Outcome measures
Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 14±2 - Frequency	-11.9 mm Standard Deviation 8.6	-16.6 mm Standard Deviation 14.9
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 28±4 -Frequency	-25.0 mm Standard Deviation 12.2	-26.5 mm Standard Deviation 18.0
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 31-41 - Frequency	-27.8 mm Standard Deviation 14.5	-30.9 mm Standard Deviation 19.2
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 14±2 - Severity	-10.6 mm Standard Deviation 6.0	-13.7 mm Standard Deviation 12.8
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 28±4 - Severity	-22.2 mm Standard Deviation 14.1	-21.8 mm Standard Deviation 14.1
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 31-41 - Severity	-25.6 mm Standard Deviation 16.6	-25.4 mm Standard Deviation 14.5
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 14±2 - Overall Score	-11.2 mm Standard Deviation 6.9	-15.3 mm Standard Deviation 13.6
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 28±4 - Overall score	-23.5 mm Standard Deviation 11.9	-24.2 mm Standard Deviation 15.7
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) Day 31-41 - Overall Score	-26.6 mm Standard Deviation 13.4	-28.3 mm Standard Deviation 16.5

SECONDARY outcome

Timeframe: From Visit 2 (Day 1)" i.e., the day of the first IMD administration to Visit 5 - Final visit/Follow up - Day 31- 41

Population: The Safety Population (SAF) included all subjects who received at least one dose of the IMDs (Lubricin or Sodium Hyaluronate-OcuYal®).

Occurrence of Treatment-emergent adverse events (TEAEs), including adverse device effects (ADEs) assessed throughout the study after the first IMD administration.

Outcome measures

Outcome measures
Measure	Lubricin PP n=27 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=29 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) All TEAEs	4 Number of adverse events	6 Number of adverse events
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) TEAEs - Related to Treatment	4 Number of adverse events	0 Number of adverse events
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) TEAEs - Not Related to Treatment	0 Number of adverse events	6 Number of adverse events
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) TEAEs - Unknown	0 Number of adverse events	5 Number of adverse events
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) TEAEs - Mild	0 Number of adverse events	0 Number of adverse events
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) TEAEs - Moderate	4 Number of adverse events	1 Number of adverse events
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) TEAEs - Severe	0 Number of adverse events	0 Number of adverse events
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) All serious TEAEs	0 Number of adverse events	0 Number of adverse events
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) TEAEs - Leading to discontinuation	4 Number of adverse events	0 Number of adverse events

SECONDARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

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 ophthalmic 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

Outcome measures
Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign Body sensation - Non Study eye -Day 14±2	-9.4 mm Standard Deviation 10.8	-11.7 mm Standard Deviation 10.4
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign Body sensation - Study eye -Day 14±2	-12.6 mm Standard Deviation 11.4	-16.2 mm Standard Deviation 15.4
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning /Stinging - Study eye - Day 14±2	-15.9 mm Standard Deviation 13.5	-15.7 mm Standard Deviation 17.2
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning /Stinging - Non Study eye - Day 14±2	-8.9 mm Standard Deviation 12.1	-8.6 mm Standard Deviation 10.1
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study eye - Day 14±2	-15.7 mm Standard Deviation 12.7	-10.9 mm Standard Deviation 15.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non Study eye - Day 14±2	-10.9 mm Standard Deviation 15.7	-8.9 mm Standard Deviation 12.6
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study eye - Day 14±2	-13.7 mm Standard Deviation 13.0	-14.2 mm Standard Deviation 17.3
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non Study eye - Day 14±2	-8.2 mm Standard Deviation 12.8	-10.7 mm Standard Deviation 11.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling- Study eye - Day 14±2	-13.5 mm Standard Deviation 12.5	-5.6 mm Standard Deviation 15.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling- Non Study eye - Day 14±2	-11.2 mm Standard Deviation 9.8	-5.7 mm Standard Deviation 12.2
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision- Study eye - Day 14±2	-11.3 mm Standard Deviation 16.1	-12.0 mm Standard Deviation 15.3
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision- Non Study eye - Day 14±2	-9.1 mm Standard Deviation 14.5	-5.7 mm Standard Deviation 12.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study eye - Day 14±2	-19.5 mm Standard Deviation 17.3	-18.5 mm Standard Deviation 17.5
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non Study eye - Day 14±2	-11.7 mm Standard Deviation 13.4	-19.5 mm Standard Deviation 20.9
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Total score - Study eye - Day 14±2	-102.2 mm Standard Deviation 64.2	-93.2 mm Standard Deviation 74.3
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Total score - Non Study eye - Day 14±2	-69.5 mm Standard Deviation 48.9	-70.9 mm Standard Deviation 56.3
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign Body sensation - Study eye -Day 28±4	-25.0 mm Standard Deviation 17.6	-26.7 mm Standard Deviation 19.8
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign Body sensation - Non Study eye -Day 28±4	-17.0 mm Standard Deviation 17.3	-21.8 mm Standard Deviation 12.1
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning /Stinging - Study eye - Day 28±4	-27.6 mm Standard Deviation 18.36	-23.0 mm Standard Deviation 20.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning /Stinging - Non Study eye - Day 28±4	-14.6 mm Standard Deviation 16.3	-12.3 mm Standard Deviation 15.6
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study eye - Day 28±4	-27.6 mm Standard Deviation 18.5	-18.5 mm Standard Deviation 17.3
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non Study eye - Day 28±4	-19.3 mm Standard Deviation 16.8	-15.1 mm Standard Deviation 16.2
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study eye - Day 28±4	-24.1 mm Standard Deviation 18.4	-20.1 mm Standard Deviation 18.4
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non Study eye - Day 28±4	-15.0 mm Standard Deviation 18.8	-14.5 mm Standard Deviation 15.3
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling- Study eye - Day 28±4	-21.9 mm Standard Deviation 18.6	-13.1 mm Standard Deviation 21.5
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Non Study eye - Day 28±4	-17.6 mm Standard Deviation 19.4	-9.2 mm Standard Deviation 18.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Study eye - Day 28±4	-14.0 mm Standard Deviation 19.4	-15.6 mm Standard Deviation 24.5
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Non Study eye - Day 28±4	-13.4 mm Standard Deviation 18.6	-8.8 mm Standard Deviation 19.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study eye - Day 28±4	-28.8 mm Standard Deviation 25.1	-26.1 mm Standard Deviation 23.4
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non Study eye - Day 28±4	-17.1 mm Standard Deviation 27.1	-23.3 mm Standard Deviation 26.2
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Total score - Study eye - Day 28±4	-168.9 mm Standard Deviation 82.8	-143.1 mm Standard Deviation 107.5
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Total score - Non Study eye - Day 28±4	-114.1 mm Standard Deviation 74.3	-105.0 mm Standard Deviation 75.9
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign Body sensation - Study eye - Day 31-41	-28.3 mm Standard Deviation 21.8	-28.1 mm Standard Deviation 18.2
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Foreign Body sensation - Non study eye - Day 31-41	-19.7 mm Standard Deviation 15.8	-18.4 mm Standard Deviation 14.2
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging -Study eye -Day 31-41	-30.5 mm Standard Deviation 23.5	-23.6 mm Standard Deviation 20.2
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Burning/Stinging - Non study eye - Day 31-41	-11.1 mm Standard Deviation 19.2	-14.1 mm Standard Deviation 18.6
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Study eye - Day 31-41	-28.6 mm Standard Deviation 22.9	-19.1 mm Standard Deviation 21.4
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Itching - Non study eye - Day 31-41	-18.9 mm Standard Deviation 17.5	-15.7 mm Standard Deviation 21.4
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Study eye - Day 31-41	-26.9 mm Standard Deviation 20.1	-20.7 mm Standard Deviation 18.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Pain - Non study eye - Day 31-41	-12.0 mm Standard Deviation 21.7	-18.6 mm Standard Deviation 19.4
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Study eye - Day 31-41	-20.5 mm Standard Deviation 23.1	-13.3 mm Standard Deviation 19.4
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Sticky feeling - Non study eye - Day 31-41	-21.4 mm Standard Deviation 21.8	-5.2 mm Standard Deviation 16.3
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Study eye - Day 31-41	-14.6 mm Standard Deviation 19.4	-15.3 mm Standard Deviation 23.9
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Blurred vision - Non study eye - Day 31-41	-10.9 mm Standard Deviation 19.8	-9.8 mm Standard Deviation 18.7
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Study eye - Day 31-41	-25.3 mm Standard Deviation 25.1	-24.9 mm Standard Deviation 26.0
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Photophobia - Non study eye - Day 31-41	-17.6 mm Standard Deviation 27.5	-19.9 mm Standard Deviation 26.6
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Total score - Study eye - Day 31-41	-174.8 mm Standard Deviation 96.0	-145.1 mm Standard Deviation 102.2
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) Total score - Non study eye - Day 31-41	-11.5 mm Standard Deviation 86.2	-101.4 mm Standard Deviation 95.8

SECONDARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

Tear film osmolarity as a marker of tear film solute content was performed with a TearLab Osmolarity System. The concentration of the tears was assessed in both eyes before the instillation of any dilating or anaesthetic drops. The tear fluid was collected onto the bottom tip of the test card by passive capillary action. After a successful tear collection, the Pen was docked into the Reader, which showed the quantitative tear film osmolarity result in mOsm/L on the liquid crystal display. Normal Patients: 275-316 mOsms/L (mean 302 mOsms/L), Dry Eye Disease Patients: \> 316 mOsms/L. The higher the score the worst the outcome.

Outcome measures

Outcome measures
Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Change From Baseline in Tear Film Osmolarity Day 14±2 - Study eye	-9.6 mOsm /L Standard Deviation 15.0	-12.7 mOsm /L Standard Deviation 11.8
Change From Baseline in Tear Film Osmolarity Day 14±2 - Non Study eye	-10.3 mOsm /L Standard Deviation 8.4	-12.1 mOsm /L Standard Deviation 11.5
Change From Baseline in Tear Film Osmolarity Day 28±4 - Study eye	-7.0 mOsm /L Standard Deviation 24.4	-12.4 mOsm /L Standard Deviation 11.3
Change From Baseline in Tear Film Osmolarity Day 28±4 - Non study eye	-10.8 mOsm /L Standard Deviation 11.4	-12.7 mOsm /L Standard Deviation 13.0
Change From Baseline in Tear Film Osmolarity Day 31-41 - Study eye	-7.6 mOsm /L Standard Deviation 14.4	-9.2 mOsm /L Standard Deviation 10.2
Change From Baseline in Tear Film Osmolarity Day 31-41 - Non study eye	-7.8 mOsm /L Standard Deviation 8.0	-11.2 mOsm /L Standard Deviation 11.5

SECONDARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

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

Outcome measures
Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Day 28±4 - Study eye	0.0 score on a scale Standard Deviation 1.6	-0.3 score on a scale Standard Deviation 1.5
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Day 28±4 - Non study eye	0.0 score on a scale Standard Deviation 1.2	-0.4 score on a scale Standard Deviation 1.8
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Day 31-41 - Study eye	0.1 score on a scale Standard Deviation 1.8	-0.2 score on a scale Standard Deviation 1.9
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Day 31-41 - Non study eye	-0.3 score on a scale Standard Deviation 1.3	-0.5 score on a scale Standard Deviation 1.8
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Day 14±2 - Study eye	0.0 score on a scale Standard Deviation 1.2	-0.1 score on a scale Standard Deviation 1.0
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score Day 14±2 -Non study eye	-0.2 score on a scale Standard Deviation 0.8	-0.3 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

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

Outcome measures
Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Day 14±2 - Study eye	1.0 seconds Standard Deviation 2.0	1.1 seconds Standard Deviation 2.5
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Day 14±2 - Non study eye	0.6 seconds Standard Deviation 2.7	1.6 seconds Standard Deviation 2.6
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Day 28±4 - Study eye	1.3 seconds Standard Deviation 2.1	1.9 seconds Standard Deviation 2.7
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Day 28±4 - Non study eye	0.3 seconds Standard Deviation 2.8	2.5 seconds Standard Deviation 2.8
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Day 31-41 - Study eye	0.5 seconds Standard Deviation 1.8	1.0 seconds Standard Deviation 1.8
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) Day 31-41 - Non study eye	0.5 seconds Standard Deviation 2.5	1.4 seconds Standard Deviation 2.0

SECONDARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

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

SECONDARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

The corneal fluorescein staining was graded by using the Oxford scheme to assess cornea and conjunctiva epithelium damage. The Oxford grading scale divides corneal staining into six groups according to severity from 0 (absent) to 5 (severe). The examiner compared the overall appearance of the patient's corneal staining with a reference figure, simulating the pattern of staining encountered in dry eye disease. No attempt was made to count the dots or to assess the position or confluence of the dots. The examiner selected the appropriate grade that best represented the state of corneal staining. The grading system recommended by NEI divides the cornea into five zones (central, superior, temporal, nasal, and inferior) and for each zone, the severity of corneal fluorescein staining is graded on a scale from 0 to 3 based on reference figures. Therefore, the maximum score (worst outcome) was 15, the minimum (best outcome) was 0.

Outcome measures

Outcome measures
Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) Day 14±2 - Study eye	-0.3 score on a scale Standard Deviation 0.4	-0.4 score on a scale Standard Deviation 0.6
Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) Day 14±2 - Non study eye	-0.3 score on a scale Standard Deviation 0.5	-0.5 score on a scale Standard Deviation 0.8
Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) Day 28±4 - Study eye	-0.9 score on a scale Standard Deviation 0.9	-0.8 score on a scale Standard Deviation 0.9
Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) Day 28±4 - Non study eye	-0.7 score on a scale Standard Deviation 0.6	-0.7 score on a scale Standard Deviation 0.9
Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) Day 31-41 - Study eye	-1.0 score on a scale Standard Deviation 0.9	-1.0 score on a scale Standard Deviation 0.9
Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) Day 31-41 - Non study eye	-1.0 score on a scale Standard Deviation 0.9	-0.7 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

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 Schimer'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

Outcome measures
Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) Day 28±4 - Non study eye	1.1 mm/5min Standard Deviation 3.2	1.5 mm/5min Standard Deviation 2.6
Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) Day 14±2 - Study eye	0.7 mm/5min Standard Deviation 2.4	1.0 mm/5min Standard Deviation 2.8
Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) Day 14±2 - Non study eye	0.9 mm/5min Standard Deviation 2.5	1.5 mm/5min Standard Deviation 3.1
Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) Day 28±4 - Study eye	1.2 mm/5min Standard Deviation 3.6	0.9 mm/5min Standard Deviation 2.5
Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) Day 31-41 - Study eye	0.5 mm/5min Standard Deviation 1.9	0.3 mm/5min Standard Deviation 2.0
Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) Day 31-41 - Non study eye	0.4 mm/5min Standard Deviation 1.6	0.7 mm/5min Standard Deviation 2.3

SECONDARY outcome

Timeframe: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41

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

Outcome measures
Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Change From Baseline in Intraocular Pressure (IOP) Day 14±2 - Study eye	0.7 mmHg Standard Deviation 1.9	-0.6 mmHg Standard Deviation 2.1
Change From Baseline in Intraocular Pressure (IOP) Day 14±2 - Non study eye	-0.4 mmHg Standard Deviation 2.1	-0.2 mmHg Standard Deviation 1.9
Change From Baseline in Intraocular Pressure (IOP) Day 28±4 - Study eye	-0.2 mmHg Standard Deviation 1.8	-0.4 mmHg Standard Deviation 2.5
Change From Baseline in Intraocular Pressure (IOP) Day 28±4 - Non study eye	-0.3 mmHg Standard Deviation 1.7	0.1 mmHg Standard Deviation 2.6
Change From Baseline in Intraocular Pressure (IOP) Day 31-41 - Study eye	-0.8 mmHg Standard Deviation 2.6	-0.9 mmHg Standard Deviation 2.5
Change From Baseline in Intraocular Pressure (IOP) Day 31-41 - Non study eye	-0.5 mmHg Standard Deviation 2.5	-0.2 mmHg Standard Deviation 2.6

Adverse Events

Lubricin SAF

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sodium Hyaluronate SAF

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lubricin SAF n=27 participants at risk Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate SAF n=29 participants at risk Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Eye disorders Eye irritation	3.7% 1/27 • Number of events 1 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.	0.00% 0/29 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.
Eye disorders Dry eye	0.00% 0/27 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.	3.4% 1/29 • Number of events 4 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.
Eye disorders Eye oedema	3.7% 1/27 • Number of events 1 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.	0.00% 0/29 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.
Eye disorders Foreign body sensation in eyes	0.00% 0/27 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.	3.4% 1/29 • Number of events 1 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.
Eye disorders Lacrimation increased	3.7% 1/27 • Number of events 1 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.	0.00% 0/29 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.
Eye disorders Vision blurred	3.7% 1/27 • Number of events 1 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.	0.00% 0/29 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.
Infections and infestations Staphylococcal infection	0.00% 0/27 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.	3.4% 1/29 • Number of events 1 • AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.

Additional Information

Clinical Development & operations

Dompé farmaceutici SpA

Phone: +39583831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lubricin PP n=24 Participants Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops	Sodium Hyaluronate PP n=27 Participants Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops
Change From Baseline in Slit Lamp Examination (SLE) Values Lens - Non study eye - Day 31-41	0.0 score on a scale Standard Deviation 0.2	-0.1 score on a scale Standard Deviation 0.3
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Meibomian gland - Study eye - Day 14±2	-0.5 score on a scale Standard Deviation 0.6	-0.4 score on a scale Standard Deviation 0.5
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Meibomian gland - Non study eye - Day 14±2	-0.5 score on a scale Standard Deviation 0.6	-0.4 score on a scale Standard Deviation 0.6
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Erythema - Study eye - Day 14±2	-0.3 score on a scale Standard Deviation 0.6	-0.4 score on a scale Standard Deviation 0.7
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Erythema - Non study eye - Day 14±2	-0.2 score on a scale Standard Deviation 0.6	-0.4 score on a scale Standard Deviation 0.7
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Oedema - Study eye - Day 14±2	-0.2 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 Eyelid - Oedema - Non study eye - Day 14±2	-0.2 score on a scale Standard Deviation 0.4	-0.1 score on a scale Standard Deviation 0.5
Change From Baseline in Slit Lamp Examination (SLE) Values Lashes - Study eye - Day 14±2	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 14±2	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 14±2	-0.4 score on a scale Standard Deviation 0.6	-0.4 score on a scale Standard Deviation 0.7
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - Erythema - Non study eye - Day 14±2	-0.3 score on a scale Standard Deviation 0.6	-0.4 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - Oedema - Study eye - Day 14±2	0.0 score on a scale Standard Deviation 0.5	-0.1 score on a scale Standard Deviation 0.7
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - Oedema - Non study eye - Day 14±2	-0.1 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 Lens - Study eye - Day 14±2	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.3
Change From Baseline in Slit Lamp Examination (SLE) Values Lens - Non study eye - Day 14±2	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.2
Change From Baseline in Slit Lamp Examination (SLE) Values Iris - Study eye - Day 14±2	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 14±2	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 14±2	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 14±2	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 14±2	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.2
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Meibomian gland - Non study eye -Day 28±4	-0.5 score on a scale Standard Deviation 0.8	-0.6 score on a scale Standard Deviation 0.7
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea transparency - Non study eye - Day 14±2	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.2
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea neovascularisation - Study eye - Day 14±2	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 neovascularisation - Non study eye - Day 14±2	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 gland - Study eye - Day 28±4	-0.5 score on a scale Standard Deviation 0.7	-0.7 score on a scale Standard Deviation 0.7
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - erythema - Study eye - Day 28±4	-0.5 score on a scale Standard Deviation 0.7	-0.4 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - erythema - Non study eye - Day 28±4	-0.5 score on a scale Standard Deviation 0.9	-0.4 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Oedema - Study eye - Day 28±4	-0.3 score on a scale Standard Deviation 0.8	-0.3 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Oedema - Non study eye - Day 28±4	-0.3 score on a scale Standard Deviation 0.7	-0.2 score on a scale Standard Deviation 0.7
Change From Baseline in Slit Lamp Examination (SLE) Values Lashes - Study eye - Day 28±4	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 28±4	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 28±4	-0.6 score on a scale Standard Deviation 0.8	-0.6 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - erythema - Non study eye - Day 28±4	-0.4 score on a scale Standard Deviation 0.9	-0.5 score on a scale Standard Deviation 0.9
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - Oedema - Study eye - Day 28±4	-0.2 score on a scale Standard Deviation 0.7	0.0 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - Oedema - Non study eye - Day 28±4	0.0 score on a scale Standard Deviation 0.7	-0.1 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Lens - Study eye - Day 28±4	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.3
Change From Baseline in Slit Lamp Examination (SLE) Values Lens - Non study eye - Day 28±4	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.2
Change From Baseline in Slit Lamp Examination (SLE) Values Iris - Study eye - Day 28±4	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 28±4	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 28±4	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 28±4	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 tranparency - Study eye - Day 28±4	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.2
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea tranparency - Non study eye - Day 28±4	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.2
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea neovascularization - Study eye - Day 28±4	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 28±4	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 gland - Study eye - Day 31-41	-0.6 score on a scale Standard Deviation 0.8	-0.9 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Meibomian gland - Non study eye - Day 31-41	-0.7 score on a scale Standard Deviation 0.9	-0.7 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - erythema - Study eye - Day 31-41	-0.6 score on a scale Standard Deviation 0.7	-0.6 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - erythema - Non study eye - Day 31-41	-0.6 score on a scale Standard Deviation 0.9	-0.4 score on a scale Standard Deviation 0.8
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Oedema - Study eye - Day 31-41	-0.4 score on a scale Standard Deviation 0.7	0.0 score on a scale Standard Deviation 0.6
Change From Baseline in Slit Lamp Examination (SLE) Values Eyelid - Oedema - Non study eye - Day 31-41	-0.3 score on a scale Standard Deviation 0.9	0.0 score on a scale Standard Deviation 0.6
Change From Baseline in Slit Lamp Examination (SLE) Values Lashes - Study eye - Day 31-41	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 31-41	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 31-41	-0.8 score on a scale Standard Deviation 1.0	-0.4 score on a scale Standard Deviation 1.0
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - erythema - Non study eye - Day 31-41	-0.5 score on a scale Standard Deviation 1.0	-0.4 score on a scale Standard Deviation 0.9
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - Oedema - Study eye - Day 31-41	-0.1 score on a scale Standard Deviation 0.9	0.0 score on a scale Standard Deviation 0.9
Change From Baseline in Slit Lamp Examination (SLE) Values Conjunctiva - Oedema - Non study eye - Day 31-41	0.0 score on a scale Standard Deviation 0.8	-0.1 score on a scale Standard Deviation 0.9
Change From Baseline in Slit Lamp Examination (SLE) Values Lens - Study eye - Day 31-41	0.0 score on a scale Standard Deviation 0.2	0.0 score on a scale Standard Deviation 0.4
Change From Baseline in Slit Lamp Examination (SLE) Values Iris - Study eye - Day 31-41	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 31-41	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 31-41	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 31-41	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 31-41	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.2
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea transparency - Non study eye - Day 31-41	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.2
Change From Baseline in Slit Lamp Examination (SLE) Values Cornea neovascularization - Study eye - Day 31-41	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 31-41	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0