Trial Outcomes & Findings for A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye (NCT NCT03368404)

Last Updated: 2025-05-14

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 (best outcome) to 5 (worst outcome), with the Ocular Surface Fluorescein Score (OSFS) ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 sub-scores (corneal, 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

Target enrollment

92 participants

Primary outcome timeframe

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

Results posted on

2025-05-14

Participant Flow

Participants were recruited from 16 sites in France

92 enrolled participants underwent a washout period of 2 weeks with povidone 2% eye drops in both eyes. Following completion of the washout period, 87 participants met inclusion criteria and were randomized either to CBL-202 or Vismed Multi treatment group. Both eyes of each participant were treated with assigned eye drops.

Participant milestones

Participant milestones
Measure	CBL-102 Eye Drops Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Overall Study STARTED	48	39
Overall Study Safety Population	47	39
Overall Study Intention-to-treat- Population	47	38
Overall Study Per Protocol Population Day 28	45	34
Overall Study Per Protocol Population Day 90	44	33
Overall Study COMPLETED	45	37
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CBL-102 Eye Drops Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBL-102 Eye Drops n=47 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate	Total n=85 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 14.3 • n=47 Participants	64.8 years STANDARD_DEVIATION 14.7 • n=38 Participants	63.6 years STANDARD_DEVIATION 14.4 • n=85 Participants
Sex: Female, Male Female	32 Participants n=47 Participants	27 Participants n=38 Participants	59 Participants n=85 Participants
Sex: Female, Male Male	15 Participants n=47 Participants	11 Participants n=38 Participants	26 Participants n=85 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	47 participants n=47 Participants	38 participants n=38 Participants	85 participants n=85 Participants
Ocular surface fluorescein staining	5.7 units on a scale STANDARD_DEVIATION 1.2 • n=47 Participants	5.9 units on a scale STANDARD_DEVIATION 1.3 • n=38 Participants	5.8 units on a scale STANDARD_DEVIATION 1.3 • n=85 Participants
Corneal fluorescein staining score	1.9 units on a scale STANDARD_DEVIATION 0.8 • n=47 Participants	1.9 units on a scale STANDARD_DEVIATION 0.9 • n=38 Participants	1.9 units on a scale STANDARD_DEVIATION 0.8 • n=85 Participants
Nasal conjunctival fluorescein staining score	1.9 units on a scale STANDARD_DEVIATION 0.6 • n=47 Participants	1.9 units on a scale STANDARD_DEVIATION 0.7 • n=38 Participants	1.9 units on a scale STANDARD_DEVIATION 0.6 • n=85 Participants
Temporal conjunctival fluorescein staining score	1.9 units on a scale STANDARD_DEVIATION 0.6 • n=47 Participants	2.1 units on a scale STANDARD_DEVIATION 0.6 • n=38 Participants	2.0 units on a scale STANDARD_DEVIATION 0.6 • n=85 Participants
Global dry eye symptoms score	11.0 units on a scale STANDARD_DEVIATION 3.8 • n=47 Participants	9.0 units on a scale STANDARD_DEVIATION 3.8 • n=38 Participants	10.1 units on a scale STANDARD_DEVIATION 3.9 • n=85 Participants
Ocular surface disease-Quality of life (OSD-QoL®) Daily activities	65.9 units on a scale STANDARD_DEVIATION 19.6 • n=44 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	64.7 units on a scale STANDARD_DEVIATION 24.5 • n=36 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	65.4 units on a scale STANDARD_DEVIATION 21.8 • n=80 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.
Ocular surface disease-Quality of life (OSD-QoL®) Difficulties with work and handicap	75.1 units on a scale STANDARD_DEVIATION 17.7 • n=37 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	74.9 units on a scale STANDARD_DEVIATION 22.4 • n=30 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	75.0 units on a scale STANDARD_DEVIATION 19.8 • n=67 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.
Ocular surface disease-Quality of life (OSD-QoL®) Giving up makeup	63.0 units on a scale STANDARD_DEVIATION 33.2 • n=25 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	54.2 units on a scale STANDARD_DEVIATION 35.1 • n=24 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	58.7 units on a scale STANDARD_DEVIATION 34.1 • n=49 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.
Ocular surface disease-Quality of life (OSD-QoL®) Acknowledgement of the disease	34.9 units on a scale STANDARD_DEVIATION 19.9 • n=44 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	31.3 units on a scale STANDARD_DEVIATION 19.2 • n=36 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	33.3 units on a scale STANDARD_DEVIATION 19.6 • n=80 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.
Ocular surface disease-Quality of life (OSD-QoL®) Acceptance of the disease	76.7 units on a scale STANDARD_DEVIATION 24.4 • n=44 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	61.8 units on a scale STANDARD_DEVIATION 35.6 • n=36 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	70.0 units on a scale STANDARD_DEVIATION 30.7 • n=80 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.
Ocular surface disease-Quality of life (OSD-QoL®) Fear for the future	59.2 units on a scale STANDARD_DEVIATION 16.9 • n=43 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	55.1 units on a scale STANDARD_DEVIATION 19.9 • n=36 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	57.3 units on a scale STANDARD_DEVIATION 18.3 • n=79 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.
Ocular surface disease-Quality of life (OSD-QoL®) Emotional well-being	82.7 units on a scale STANDARD_DEVIATION 19.3 • n=44 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	80.0 units on a scale STANDARD_DEVIATION 20.6 • n=35 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	81.5 units on a scale STANDARD_DEVIATION 19.8 • n=79 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.
Ocular surface disease-Quality of life (OSD-QoL®) Global Question	50.6 units on a scale STANDARD_DEVIATION 19.8 • n=44 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	50.0 units on a scale STANDARD_DEVIATION 23.1 • n=36 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.	50.3 units on a scale STANDARD_DEVIATION 21.2 • n=80 Participants • Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women.
Tear film break-up time (TFBUT)	5.9 seconds STANDARD_DEVIATION 1.7 • n=47 Participants	5.4 seconds STANDARD_DEVIATION 1.9 • n=38 Participants	5.7 seconds STANDARD_DEVIATION 1.8 • n=85 Participants
Schirmer's test	7.2 millimeters STANDARD_DEVIATION 5.0 • n=47 Participants	7.1 millimeters STANDARD_DEVIATION 4.8 • n=38 Participants	7.1 millimeters STANDARD_DEVIATION 4.9 • n=85 Participants

PRIMARY outcome

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

Population: Per-protocol population: all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)

Outcome measures

Outcome measures
Measure	CBL-102 Eye Drops n=45 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28	-2.1 score on a scale Standard Error 0.2	-1.5 score on a scale Standard Error 0.3

SECONDARY outcome

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

Population: Two participants of per-protocol population, one in each group withdrew before 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 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

Outcome measures
Measure	CBL-102 Eye Drops n=44 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	Vismed® Multi Eye Drops n=33 Participants Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)	-3.1 score on a scale Standard Error 0.3	-2.3 score on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28) and 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 (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 Corneal Region is graded separately from 0 (best outcome) to 5 (worst outcome).

Outcome measures

Outcome measures
Measure	CBL-102 Eye Drops n=45 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) CFB in Corneal Fluorescein Score at Day 28 (Visit 4)	-0.8 score on a scale Standard Error 0.1	-0.6 score on a scale Standard Error 0.1
Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) CFB in Corneal Fluorescein Score at Day 90 (Visit 5)	-1.0 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 4 (Day 28) and Visit 5 (Day 90)

Population: Two participants of the per-protocol population, one in each group withdrew before Day 90 (Visit 5)

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

Outcome measures
Measure	CBL-102 Eye Drops n=45 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) Change from Baseline in NAsal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)	-0.6 score on a scale Standard Error 0.1	-0.4 score on a scale Standard Error 0.1
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) Change from Baseline in Nasal Conjunctival Fluorescein Staining Score at day 90 (Visit 5)	-0.9 score on a scale Standard Error 0.1	-0.6 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)

Population: Two participants of the per-protocol population, on in each group withdrew before Day 90 (Visit 5)

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

Outcome measures
Measure	CBL-102 Eye Drops n=45 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) Change From Baseline in temporal Conjunctival Staining Score at Day 28 (Visit 4)	-0.8 score on a scale Standard Error 0.1	-0.4 score on a scale Standard Error 0.1
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) Change From BAseline in Temporal Conjunctival Staining Score at Day 90 (Visit 5)	-1.2 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 4 (Day 28) and 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

Outcome measures
Measure	CBL-102 Eye Drops n=45 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5) Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day (Visit 4)	-3.9 score on a scale Standard Error 0.5	-2.1 score on a scale Standard Error 0.5
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5) Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)	-6.3 score on a scale Standard Error 0.5	-3.9 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 Questionnaire dimension or Global question on both 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) is 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

Outcome measures
Measure	CBL-102 Eye Drops n=40 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	Vismed® Multi Eye Drops n=31 Participants Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device, tear substitute 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	11.3 score on a scale Standard Error 1.9	4.8 score on a scale Standard Error 2.1
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Difficulties with work and handicap	9.8 score on a scale Standard Error 1.5	1.6 score on a scale Standard Error 1.9
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Giving up makeup	14.1 score on a scale Standard Error 3.9	7.1 score on a scale Standard Error 3.7
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) acknowledgement of the disease	5.1 score on a scale Standard Error 2.7	-3.3 score on a scale Standard Error 3.0
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) acceptance of the disease	2.7 score on a scale Standard Error 3.4	-1.8 score on a scale Standard Error 3.9
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Fear for the future	10.8 score on a scale Standard Error 2.1	4.6 score on a scale Standard Error 2.4
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) Emotional well-beig	5.5 score on a scale Standard Error 2.0	4.4 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	17.6 score on a scale Standard Error 2.4	9.5 score on a scale Standard Error 2.8

SECONDARY outcome

Timeframe: Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)

Population: Per-protocol population. Two participants of the per-protocol population, one in each group, withdrew before the Day 90 (Visit 5).

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 tenth of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.

Outcome measures

Outcome measures
Measure	CBL-102 Eye Drops n=45 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at Day 90 (Visit 5) Change From Baseline Tear Film Break Up Time (TFBUT) at day 28 (Visit 4)	1.2 seconds Standard Error 0.3	0.8 seconds Standard Error 0.3
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at Day 90 (Visit 5) Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 90 (Visit 5)	1.3 seconds Standard Error 0.2	0.7 seconds Standard Error 0.3

SECONDARY outcome

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

Population: Per -protocol population

Tear fluid secretion was assessed by the un-anaesthetized Schirmer 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 ready to the nearest mm from the graduated strip margins.

Outcome measures

Outcome measures
Measure	CBL-102 Eye Drops n=45 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	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, tear substitute with 0.18% sodium hyaluronate
Change From Baseline in Schirmer Test at Day 28 (Visit 4)	1.2 mm/5 min Standard Error 0.4	0.7 mm/5 min Standard Error 0.5

SECONDARY outcome

Timeframe: From Day 0 to Day 90, an average of 3 months

Population: Two participants of the per-protocol population, one in each group withdrew before the Day 90 (Visit 5).

Mean daily frequency of investigational eye drop instillations as reported in participant's diary

Outcome measures

Outcome measures
Measure	CBL-102 Eye Drops n=44 Participants Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides	Vismed® Multi Eye Drops n=33 Participants Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate
Frequency of Eye Drop Instillation	3.4 drops per day Standard Deviation 0.6	4.0 drops per day Standard Deviation 1.0

Adverse Events

CBL-102 Eye Drops

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Vismed® Multi Eye Drops

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CBL-102 Eye Drops n=47 participants at risk Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides Safety population	Vismed® Multi Eye Drops n=39 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, tear substitute with 0.18% sodium hyaluronate Safety population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	2.1% 1/47 • Number of events 1 • 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	0.00% 0/39 • 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

Other adverse events

Other adverse events
Measure	CBL-102 Eye Drops n=47 participants at risk Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides Safety population	Vismed® Multi Eye Drops n=39 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, tear substitute with 0.18% sodium hyaluronate Safety population
Eye disorders Eye discharge	0.00% 0/47 • 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	5.1% 2/39 • Number of events 2 • 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
Eye disorders Eye pain	0.00% 0/47 • 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	5.1% 2/39 • Number of events 2 • 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: [email protected]

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