Trial Outcomes & Findings for A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye (NCT NCT02975102)

NCT ID: NCT02975102

Last Updated: 2024-06-24

Results Overview

Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions). The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: Baseline (Day 0), Visit 4 (Day 28)
• Results posted on: 2024-06-24

Participant Flow

Participants were recruited from 15 sites in France and 3 sites in Belgium

87 enrolled participants underwent a washout period of 2 weeks with povidone 2% eye drops in both eyes. Following completion of the washout period, 83 participants met inclusion criteria and were randomized either to CBL-101 or Vismed Multi treatment group. Both eyes of each participant were treated with the assigned eye drops.

Participant milestones

Measure	CBL-101 Eye Drops Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Overall Study STARTED	45	38
Overall Study Safety Population	45	38
Overall Study Intention-to-treat Population	45	38
Overall Study Per Protocol Population Day 7	42	34
Overall Study Per Protocol Population Day 28	43	35
Overall Study Per Protocol Population Day 90	42	34
Overall Study COMPLETED	43	37
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	CBL-101 Eye Drops Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Overall Study Adverse Event	2	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CBL-101 Eye Drops n=45 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate, and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=38 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate	Total n=83 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 14.0 • n=45 Participants	60.6 years STANDARD_DEVIATION 14.1 • n=38 Participants	62.3 years STANDARD_DEVIATION 14.0 • n=83 Participants
Sex: Female, Male Female	34 Participants n=45 Participants	29 Participants n=38 Participants	63 Participants n=83 Participants
Sex: Female, Male Male	11 Participants n=45 Participants	9 Participants n=38 Participants	20 Participants n=83 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	39 participants n=45 Participants	33 participants n=38 Participants	72 participants n=83 Participants
Region of Enrollment Belgium	6 participants n=45 Participants	5 participants n=38 Participants	11 participants n=83 Participants
Ocular surface fluorescein staining	5.4 units on a scale STANDARD_DEVIATION 1.3 • n=45 Participants	5.3 units on a scale STANDARD_DEVIATION 1.5 • n=38 Participants	5.3 units on a scale STANDARD_DEVIATION 1.4 • n=83 Participants
Corneal fluorescein staining score	1.8 units on a scale STANDARD_DEVIATION 0.7 • n=45 Participants	1.9 units on a scale STANDARD_DEVIATION 0.8 • n=38 Participants	1.9 units on a scale STANDARD_DEVIATION 0.8 • n=83 Participants
Nasal conjunctival fluorescein staining score	1.8 units on a scale STANDARD_DEVIATION 0.7 • n=45 Participants	1.7 units on a scale STANDARD_DEVIATION 0.7 • n=38 Participants	1.8 units on a scale STANDARD_DEVIATION 0.7 • n=83 Participants
Temporal conjunctival fluorescein staining score	1.7 units on a scale STANDARD_DEVIATION 0.7 • n=45 Participants	1.7 units on a scale STANDARD_DEVIATION 0.5 • n=38 Participants	1.7 units on a scale STANDARD_DEVIATION 0.6 • n=83 Participants
Global dry eye symptoms score	8.8 units on a scale STANDARD_DEVIATION 2.7 • n=45 Participants	8.2 units on a scale STANDARD_DEVIATION 3.3 • n=38 Participants	8.5 units on a scale STANDARD_DEVIATION 3.0 • n=83 Participants
Ocular surface disease-Quality of life (OSD-QoL®): Global question	45.6 units on a scale STANDARD_DEVIATION 21.8 • n=40 Participants • Some of the Quality of Life questionnaires could not be analyzed	53.9 units on a scale STANDARD_DEVIATION 22.1 • n=32 Participants • Some of the Quality of Life questionnaires could not be analyzed	49.3 units on a scale STANDARD_DEVIATION 22.2 • n=72 Participants • Some of the Quality of Life questionnaires could not be analyzed
Tear film break-up time (TFBUT)	5.5 seconds STANDARD_DEVIATION 1.6 • n=45 Participants	6.0 seconds STANDARD_DEVIATION 1.5 • n=38 Participants	5.7 seconds STANDARD_DEVIATION 1.6 • n=83 Participants
Schirmer's test	6.8 millimeters STANDARD_DEVIATION 3.7 • n=45 Participants	7.4 millimeters STANDARD_DEVIATION 2.9 • n=38 Participants	7.1 millimeters STANDARD_DEVIATION 3.3 • n=83 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28)

Population: Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)

Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).

The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.

Outcome measures

Measure	CBL-101 Eye Drops n=43 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=35 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28	-2.9 score on a scale Standard Error 0.3	-2.4 score on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 3 (Day 7)

Population: Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.

Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).

The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 7 (Visit 3)	-1.7 score on a scale Standard Error 0.2	-1.4 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 5 (Day 90)

Population: Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.

Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).

The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)	-4.0 score on a scale Standard Error 0.2	-2.6 score on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 3 (Day 7)

Population: Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.

Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Corneal Fluorescein Staining Score at Day 7 (Visit 3)	-0.5 score on a scale Standard Error 0.1	-0.4 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28)

Population: Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)

Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=43 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=35 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4)	-0.9 score on a scale Standard Error 0.1	-0.8 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 5 (Day 90)

Population: Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.

Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Corneal Fluorescein Staining Score at Day 90 (Visit 5)	-1.2 score on a scale Standard Error 0.1	-0.8 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 3 (Day 7)

Population: Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.

Mean change from baseline (CFB) in the study eye in Nasal conjunctival Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)	-0.6 score on a scale Standard Error 0.1	-0.6 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28)

Population: Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)

Mean change from baseline (CFB) in the study eye in Nasal conjunctival Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=43 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=35 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)	-1.0 score on a scale Standard Error 0.1	-0.9 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 5 (Day 90)

Population: Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.

Mean change from baseline (CFB) in the study eye in Nasal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 90 (Visit 5)	-1.4 score on a scale Standard Error 0.1	-0.8 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 3 (Day 7)

Population: Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.

Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)	-0.6 score on a scale Standard Error 0.1	-0.4 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28)

Population: Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)

Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=43 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=35 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)	-0.9 score on a scale Standard Error 0.1	-0.8 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 5 (Day 90)

Population: Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.

Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.

The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 90 (Visit 5)	-1.4 score on a scale Standard Error 0.1	-0.9 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Visit 4 (Day 28)

Population: Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)

The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4(severe and/or disabling and constant).

Outcome measures

Measure	CBL-101 Eye Drops n=43 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=35 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)	-4.2 score on a scale Standard Error 0.4	-2.2 score on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Baseline, Visit 5 (Day 90)

Population: Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.

The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4 (severe and/or disabling and constant).

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)	-5.1 score on a scale Standard Error 0.4	-3.1 score on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 5 (Day 90)

Population: Analysis population included participants in the per-protocol population with evaluable Global question on Day 0 and Day 90.

The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being. A Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) was also evaluated separately. The converted score for each dimension ranges from 0 to 100, with a higher score reflecting a better quality of life.

Outcome measures

Measure	CBL-101 Eye Drops n=37 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=28 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Daily activities	12.0 score on a scale Standard Error 1.9	5.3 score on a scale Standard Error 2.2
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Handicap and work difficulties	10.8 score on a scale Standard Error 2.0	2.4 score on a scale Standard Error 2.0
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Giving up makeup	12.2 score on a scale Standard Error 3.9	5.5 score on a scale Standard Error 4.2
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Acknowledgement of the disease	5.8 score on a scale Standard Error 3.6	2.6 score on a scale Standard Error 4.2
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Acceptance of the disease	0.5 score on a scale Standard Error 3.6	-1.5 score on a scale Standard Error 4.1
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Fear for the future	15.5 score on a scale Standard Error 2.2	5.3 score on a scale Standard Error 2.6
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Emotional well-being	6.8 score on a scale Standard Error 1.9	2.6 score on a scale Standard Error 2.2
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Global Question	17.5 score on a scale Standard Error 3.0	9.1 score on a scale Standard Error 3.5

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 3 (Day 7)

Population: Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.

The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the mean was calculated.

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 7 (Visit 3)	0.9 seconds Standard Error 0.2	0.7 seconds Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28)

Population: Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)

The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.

Outcome measures

Measure	CBL-101 Eye Drops n=43 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=35 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4)	1.2 seconds Standard Error 0.2	0.8 seconds Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 5 (Day 90)

Population: Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.

The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.

Outcome measures

Measure	CBL-101 Eye Drops n=42 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 90 (Visit 5)	1.7 seconds Standard Error 0.2	0.7 seconds Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28)

Population: Analysis population included participants in the per-protocol population with evaluable Schirmer test on Day 0 and Day 28.

Tear fluid secretion was assessed by the unanaesthetized Schirmer's test in the study eye with graduated strips in millimeters.

Schirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion read to the nearest mm from the graduated strip markings.

Outcome measures

Measure	CBL-101 Eye Drops n=41 Participants Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=34 Participants Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Change From Baseline in Schirmer Test at Day 28 (Visit 4)	1.9 mm / 5 min Standard Error 0.5	1.5 mm / 5 min Standard Error 0.5

Adverse Events

CBL-101 Eye Drops

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Vismed® Multi Eye Drops

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CBL-101 Eye Drops n=45 participants at risk Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)	Vismed® Multi Eye Drops n=38 participants at risk Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate
Eye disorders Eye irritation	4.4% 2/45 • Adverse events were collected during the whole treatment period from the first instillation until the last study visit (90 ± 10 days). Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Adverse event reports were elicited from the participants or resulted from the assessments at each study visit and recorded.	2.6% 1/38 • Adverse events were collected during the whole treatment period from the first instillation until the last study visit (90 ± 10 days). Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Adverse event reports were elicited from the participants or resulted from the assessments at each study visit and recorded.

Additional Information

Associate Director, Global Clinical Operations

Bausch + Lomb

Phone: +49 30 330 93

Email: natasa.orlic-pleyer@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor have at least 60 days to review any publication or presentation. The first release of results will involve all sites in this multicenter study.
• Publication restrictions are in place

Restriction type: OTHER