Dry EyeNCT02975102
A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
A study testing CBL-101 Eye Drops and Vismed® Multi Eye Drops in people with Dry Eye, run by Laboratoire Chauvin at 2 sites in 2 countries.
Trial summary
The primary objectives of this investigation are to show that the performance of CBL-101 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-101 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-101 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
- 87 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2017to 17 Sep 2019
- 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
- Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent
- Subjects must be able to read, understand, and provide written informed consent on the Ethics Committee (EC) approved ICF
- Subjects who are able and willing to comply with all treatment and follow-up, study procedures
- Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use multidose preservative-free artificial tear (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
- Subjects with a 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
- Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca :
Show all 11Show fewer
- Tear break-up time of ≤ 10sec (mean of 3 measurements) at both screening visit and inclusion visit
- 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
- Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes
- Subjects with no systemic treatment or who are receiving stable systemic treatment (unchanged for 1 month or longer)
- Female subjects who are not of childbearing potential or who have a negative urine pregnancy test result at screening
Who cannot join
- Ocular Exclusion Criteria
- Subjects with moderate or severe blepharitis defined by at least moderate (a score of ≥ 2 from a range of 0 to 3) eyelid margin hyperemia or moderate eyelid swelling or both and at least moderate eyelid debris or moderate plugging of meibomian glands or both
- Subjects who have severe ocular dryness accompanied by one of the following:
- Lid abnormality (except mild blepharitis)
- Corneal disease
- Ocular surface metaplasia
Show all 28Show fewer
- Filamentary keratitis
- Corneal neovascularization
- Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start
- Subjects who have received ocular surgery, including laser surgery, in either eye within 180 days prior to study start
- Subjects with a history of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
- Subjects with a history of ocular allergic disease or ocular herpes within 1 year prior to study start
- Subjects with a history of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
- Treatment Exclusion Criteria
- Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART
- Subjects with 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
- Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
- Subjects expected to receive ocular therapy during the study
- Subjects treated with topical ocular steroidal or non-steroidal antiinflammatory medication within 30 days prior to study start
- Subjects expected to receive ocular therapy with immunosuppressants (e.g. cyclosporine) during the study or who have used ocular immunosuppressants within 90 days prior to study start
- Subjects who have received occlusion therapy with lacrimal or punctum plugs within 90 days prior to study start
- General Exclusion Criteria
- Female subjects who are sexually active and who do not fall into 1 of the following categories:
- Post-menopausal
- Surgically sterile
- Using one of the following birth control methods throughout the duration of the study: Intrauterine device (at least for 14 days prior to study start) or Barrier method (condom or diaphragm) with spermicide (at least for 14 days prior to study start) or Hormonal contraception (same dose and same formulation for at least 6 months)
- Females who are breastfeeding
- Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and, or during the period of study participation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The primary objectives of this investigation are to show that the performance of CBL-101 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-101 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.
Read the detailed description
Participants in this multicenter, randomized study had a screening visit, then were randomized on Day 0 with follow-up visits on Day 7 (±1), Day 28 (± 3) and Day 90 (±10).
- Conditions
- Dry Eye
- Being tested
- CBL-101 Eye Drops, Vismed® Multi Eye Drops
- 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-101 Eye DropsDevice
CBL-101 Eye Drops 3 to 6 times per day for 3 months.
Vismed® Multi Eye DropsDevice
Vismed® Multi 3 to 6 times per day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| CBL-101 Eye Drops | Experimental | The test article, CBL-101 Eye Drops, is a CE-marked medical device containing 0.15% sodium hyaluronate and polyethylene glycol (PEG) 8000. An oxide (Oxyd®) used as a soft preservative, rapidly turns into oxygen, water and ions on contact with the eye. The formula is presented in 10 mL bottles. Receives: Device: CBL-101 Eye Drops |
| Vismed® Multi Eye Drops | Active comparator | The comparator product, Vismed® Multi ophthalmic solution (CE marked), contains 0.18% sodium hyaluronate, is unpreserved and 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 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.
Measured: Baseline (Day 0), Visit 4 (Day 28)
Secondary outcomes (18)
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 7 (Visit 3)
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.
Measured: Baseline (Day 0), Visit 3 (Day 7)
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 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.
Measured: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Corneal Fluorescein Staining Score at Day 7 (Visit 3)
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).
Measured: Baseline (Day 0), Visit 3 (Day 7)
Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4)
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).
Measured: Baseline (Day 0), Visit 4 (Day 28)
Change From Baseline in Corneal Fluorescein Staining Score at Day 90 (Visit 5)
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).
Measured: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)
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 3 (Day 7)
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)
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)
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score 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 5 (Day 90)
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)
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 3 (Day 7)
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)
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)
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score 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 5 (Day 90)
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)
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, Visit 4 (Day 28)
Change From Baseline in Global Sum Score of Dry Eye Symptoms 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, 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) 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.
Measured: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 7 (Visit 3)
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.
Measured: Baseline (Day 0), Visit 3 (Day 7)
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4)
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.
Measured: Baseline (Day 0), Visit 4 (Day 28)
Change From Baseline in Tear Film Break Up Time (TFBUT) 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 tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.
Measured: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Schirmer Test at Day 28 (Visit 4)
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.
Measured: Baseline (Day 0), Visit 4 (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start1 Mar 2017
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Chauvin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Raphaele Siou Mermet, MD, Study director, Laboratoire Chauvin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975102
- Sponsor's protocol ID
- 2016-A01121-50
- Status last verified
- Jan 2024
- First submitted
- 21 Nov 2016
- Last updated
- 24 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Labetoulle M, Mortemousque B; CBL-101 Study Group. Performance and Safety of a Sodium Hyaluronate Tear Substitute with Polyethylene Glycol in Dry Eye Disease: A Multicenter, Investigator-Masked, Randomized, Noninferiority Trial. J Ocul Pharmacol Ther. 2022 Nov;38(9):607-616. doi: 10.1089/jop.2022.0048. Epub 2022 Oct 21.
PubMed 36269661
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. 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-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
- ClinicalTrials.gov ID
- NCT02975102
- Acronym / sponsor ID
- 2016-A01121-50
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Laboratoire ChauvinIndustry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 24 Jun 2024
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 are to show that the performance of CBL-101 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-101 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.
Detailed description
Participants in this multicenter, randomized study had a screening visit, then were randomized on Day 0 with follow-up visits on Day 7 (±1), Day 28 (± 3) and Day 90 (±10).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBL-101 Eye Drops | Experimental | Device: CBL-101 Eye DropsThe test article, CBL-101 Eye Drops, is a CE-marked medical device containing 0.15% sodium hyaluronate and polyethylene glycol (PEG) 8000. An oxide (Oxyd®) used as a soft preservative, rapidly turns into oxygen, water and ions on contact with the eye. The formula is presented in 10 mL bottles. |
| Vismed® Multi Eye Drops | Active comparator | Device: Vismed® Multi Eye DropsThe comparator product, Vismed® Multi ophthalmic solution (CE marked), contains 0.18% sodium hyaluronate, is unpreserved and 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 (11 listed)
- Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent
- Subjects must be able to read, understand, and provide written informed consent on the Ethics Committee (EC) approved ICF
- Subjects who are able and willing to comply with all treatment and follow-up, study procedures
- Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use multidose preservative-free artificial tear (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
- Subjects with a 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
Key exclusion criteria (28 listed)
- Ocular Exclusion Criteria
- Subjects with moderate or severe blepharitis defined by at least moderate (a score of ≥ 2 from a range of 0 to 3) eyelid margin hyperemia or moderate eyelid swelling or both and at least moderate eyelid debris or moderate plugging of meibomian glands or both
- Subjects who have severe ocular dryness accompanied by one of the following:
- Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start
- Subjects who have received ocular surgery, including laser surgery, in either eye within 180 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-101 Eye DropsCBL-101 Eye Drops 3 to 6 times per day for 3 months. | Device | CBL-101 Eye Drops |
| Vismed® Multi Eye DropsVismed® Multi 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 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.
18 secondary outcomes
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 7 (Visit 3)
Time frame: Baseline (Day 0), Visit 3 (Day 7)
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 7 (Visit 3)
Time frame: Baseline (Day 0), Visit 3 (Day 7)
Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4)
Time frame: Baseline (Day 0), Visit 4 (Day 28)
Change From Baseline in Corneal Fluorescein Staining Score at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)
Time frame: Baseline (Day 0), Visit 3 (Day 7)
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)
Time frame: Baseline (Day 0), Visit 4 (Day 28)
Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)
Time frame: Baseline (Day 0), Visit 3 (Day 7)
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)
Time frame: Baseline (Day 0), Visit 4 (Day 28)
Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)
Time frame: Baseline, Visit 4 (Day 28)
Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)
Time frame: Baseline, 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 7 (Visit 3)
Time frame: Baseline (Day 0), Visit 3 (Day 7)
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4)
Time frame: Baseline (Day 0), Visit 4 (Day 28)
Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 90 (Visit 5)
Time frame: Baseline (Day 0), Visit 5 (Day 90)
Change From Baseline in Schirmer Test at Day 28 (Visit 4)
Time frame: Baseline (Day 0), Visit 4 (Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36269661Labetoulle M, Mortemousque B; CBL-101 Study Group. Performance and Safety of a Sodium Hyaluronate Tear Substitute with Polyethylene Glycol in Dry Eye Disease: A Multicenter, Investigator-Masked, Randomized, Noninferiority Trial. J Ocul Pharmacol Ther. 2022 Nov;38(9):607-616. doi: 10.1089/jop.2022.0048. Epub 2022 Oct 21.
- Individual participant dataSharing planned: No
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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.
Raphaele Siou Mermet, MD study director
Laboratoire Chauvin
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBL-101 Eye Drops and Vismed® Multi Eye Drops in people with Dry Eye, run by Laboratoire Chauvin at 2 sites in 2 countries.
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 11 inclusion and 28 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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 24 Jun 2024). 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?
On the ClinicalTrials.gov record for NCT02975102, which also lists 1 linked publication.
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 24 Jun 2024.