Dry EyeRESTANCT03368404
A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
A study testing CBL-102 eye drops and Vismed Multi eye drops in people with Dry Eye, run by Laboratoire Chauvin at 1 site in France.
Trial summary
The primary objectives of this investigation were to show that the performance of CBL-102 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-102 Eye Drops during a 90-day period with treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- CBL-102 eye drops and Vismed Multi eye drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2017to 2 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 18 and ability to read, understand, and provide written voluntary informed consent on the Ethics Committee approved Informed Consent Form
- Ability and willingness to comply with all treatment and follow-up and study procedures
- Use of tear substitutes for at least 2.5 months prior to inclusion, and agreement to use multidose preservative-free ART (Aqualarm® U.P. povidone 2% eye drops in 10 mL bottles) up to 6 times a day for at least 2 weeks immediately prior to randomization
- Symptom score ≥ 1 for at least 2 out of the 7 following symptoms (rated 0 to 4): sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light
- At least 1 eye with the following signs of keratoconjunctivitis sicca :
- Tear break-up time of 10 sec (mean of 3 measurements) at both screening visit and inclusion visit
Show all 14Show fewer
- Total ocular surface staining score ≥ 4 and ≤ 9 at both screening visit and inclusion visit. This assessment combines corneal, nasal and temporal bulbar conjunctival fluorescein staining, each graded 0-5 according to the Oxford Scheme
- A decimal visual acuity with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes
- No systemic treatment or who had received stable systemic treatment (unchanged for 1 month or longer)
- Female subjects had to be into 1 of the following categories:
- Post-menopausal
- Surgically sterile
- Using birth control method throughout the duration of the study
- Female of childbearing potential needed a negative urine pregnancy test result at screening
Who cannot join
- Severe blepharitis
- Severe ocular dryness accompanied by 1 of the following:
- Lid abnormality
- Corneal disease
- Ocular surface metaplasia
- Filamentary keratitis
Show all 22Show fewer
- Corneal neovascularization
- Use of contact lenses at inclusion or within 90 days prior to study start
- History of ocular surgery, including laser surgery, in either eye within 180 days prior to study start
- History of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
- History of ocular allergic disease or ocular herpes within 1 year prior to study start
- History of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
- Known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART
- Initiation of, or changes to, concomitant medication that could affect dry eye within 30 days prior to Visit 1 (Screening) or with planned initiation or changes of such medications during the study
- Ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
- Expected use of ocular therapy during the study
- Use of topical ocular steroidal or non-steroidal anti-inflammatory medication within 30 days prior to study start
- Expected use of ocular therapy with immunosuppressants during the study or use of ocular immunosuppressants within 90 days prior to study start
- Use of occlusion therapy with non-resorbable lacrimal or punctum plugs within 90 days prior to study start or use of resorbable plugs
- Use or planned use of therapy such as LipiFlow® or BlephEx®
- Breastfeeding females
- Participation in any drug or device clinical investigation within 30 days prior to entry into study and/or during the period of study participation
Trial locations and contacts
1 site in 1 country.
About this study
The primary objectives of this investigation were to show that the performance of CBL-102 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-102 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.
Read the detailed description
This was a multicenter, randomized, parallel group, investigator-masked, non-inferiority study. Approximately 84 subjects were planned to be randomized in a 1:1 ratio.
The primary performance endpoint was the mean change from baseline (CFB) in the study eye at Day 28 in the Ocular surface fluorescein staining score as assessed by the Oxford Scheme.
Following a screening visit (Visit 1) and a 2-week washout with povidone 2% artificial tear (ART), participants were randomized on Day 0 (Visit 2) with follow-up visits on Day 28 ±3 (Visit 4) and Day 90 ±10 (Visit 5). A telephone assessment took place on Day 7 ±1 ('Visit 3') for safety and compliance.
- Conditions
- Dry Eye
- Being tested
- CBL-102 eye drops, Vismed Multi eye drops
- Keywords
- dry eye, tear substitute, ocular lubricant
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBL-102 eye dropsDevice
CBL-102 eye drops, 3 to 6 times per day for 3 months
Vismed Multi eye dropsDevice
Vismed Multi eye drops, 3 to 6 times per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| CBL-102 eye drops | Experimental | CE marked medical device, tear substitute containing 0.24% hyaluronic acid salt, carbomer and medium chain triglycerides, presented in 10 mL bottles Receives: Device: CBL-102 eye drops |
| Vismed Multi eye drops | Active comparator | CE marked medical device, tear substitute containing 0.18% sodium hyaluronate, presented in 10 mL bottles Receives: Device: Vismed Multi eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28
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.
Measured: Baseline (Day 0), Visit 4 (Day 28)
Secondary outcomes (9)
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)
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.
Measured: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)
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).
Measured: Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at 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).
Measured: Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at 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).
Measured: Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5)
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).
Measured: Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5)
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.
Measured: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at 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.
Measured: Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)
Change From Baseline in Schirmer Test at Day 28 (Visit 4)
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.
Measured: Baseline (Day 0), Visit 4 (Day 28)
Frequency of Eye Drop Instillation
Mean daily frequency of investigational eye drop instillations as reported in participant's diary
Measured: From Day 0 to Day 90, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start9 Nov 2017
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Chauvin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Marc Labetoulle, M.D Ph.D, Principal investigator, Hôpital Kremlin-Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368404
- Sponsor's protocol ID
- CBL-2017-01
- Other IDs
- 2017-A01099-44
- Acronym
- RESTA
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2017
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
- ClinicalTrials.gov ID
- NCT03368404
- Acronym / sponsor ID
- RESTA / CBL-2017-01
- Conditions
- Dry Eye
- Keywords
- dry eye, tear substitute, ocular lubricant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Laboratoire ChauvinIndustry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this investigation were to show that the performance of CBL-102 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-102 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.
Detailed description
This was a multicenter, randomized, parallel group, investigator-masked, non-inferiority study. Approximately 84 subjects were planned to be randomized in a 1:1 ratio.
The primary performance endpoint was the mean change from baseline (CFB) in the study eye at Day 28 in the Ocular surface fluorescein staining score as assessed by the Oxford Scheme.
Following a screening visit (Visit 1) and a 2-week washout with povidone 2% artificial tear (ART), participants were randomized on Day 0 (Visit 2) with follow-up visits on Day 28 ±3 (Visit 4) and Day 90 ±10 (Visit 5). A telephone assessment took place on Day 7 ±1 ('Visit 3') for safety and compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBL-102 eye drops | Experimental | Device: CBL-102 eye dropsCE marked medical device, tear substitute containing 0.24% hyaluronic acid salt, carbomer and medium chain triglycerides, presented in 10 mL bottles |
| Vismed Multi eye drops | Active comparator | Device: Vismed Multi eye dropsCE marked medical device, tear substitute containing 0.18% sodium hyaluronate, presented in 10 mL bottles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age of at least 18 and ability to read, understand, and provide written voluntary informed consent on the Ethics Committee approved Informed Consent Form
- Ability and willingness to comply with all treatment and follow-up and study procedures
- Use of tear substitutes for at least 2.5 months prior to inclusion, and agreement to use multidose preservative-free ART (Aqualarm® U.P. povidone 2% eye drops in 10 mL bottles) up to 6 times a day for at least 2 weeks immediately prior to randomization
- Symptom score ≥ 1 for at least 2 out of the 7 following symptoms (rated 0 to 4): sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light
- At least 1 eye with the following signs of keratoconjunctivitis sicca :
Key exclusion criteria (22 listed)
- Severe blepharitis
- Severe ocular dryness accompanied by 1 of the following:
- Use of contact lenses at inclusion or within 90 days prior to study start
- History of ocular surgery, including laser surgery, in either eye within 180 days prior to study start
- History of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBL-102 eye dropsCBL-102 eye drops, 3 to 6 times per day for 3 months | Device | CBL-102 eye drops |
| Vismed Multi eye dropsVismed Multi eye drops, 3 to 6 times per day for 3 months | Device | Vismed Multi eye drops |
Primary outcome
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28
Time frame: Baseline (Day 0), Visit 4 (Day 28)
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.
9 secondary outcomes
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)
Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)
Change From Baseline in Schirmer Test at Day 28 (Visit 4)
Time frame: Baseline (Day 0), Visit 4 (Day 28)
Frequency of Eye Drop Instillation
Time frame: From Day 0 to Day 90, an average of 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Labetoulle, M.D Ph.D principal investigator
Hôpital Kremlin-Bicêtre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBL-102 eye drops and Vismed Multi eye drops in people with Dry Eye, run by Laboratoire Chauvin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28 (time frame: Baseline (Day 0), Visit 4 (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.