RESTA: A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
Study Details
Study Description
Brief Summary
This is a multicenter, randomized, parallel group, investigator-masked, non-inferiority study. Approximately 84 subjects will be randomized in a 1:1 ratio.The primary objectives of this investigation are 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. The primary performance endpoint for this study is the mean change from baseline (CFB) in the study eye at Visit 4 (Day 28 ± 3 days) in ocular surface fluorescein staining score.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBL-102 eye drops CE marked medical device, tear substitute containing 0.24% hyaluronic acid salt, carbomer and medium chain triglycerides |
Device: CBL-102 eye drops
CBL-102 eye drops, 3 to 6 times per day for 3 months
|
| Active Comparator: Vismed Multi eye drops CE marked medical device, tear substitute containing 0.18% sodium hyaluronate |
Device: Vismed Multi eye drops
Vismed Multi eye drops, 3 to 6 times per day for 3 months
|
Outcome Measures
Primary Outcome Measures
- Total ocular surface fluorescein staining score at Visit 4 [Baseline (Day 0), Visit 4 (Day 28)]
The primary performance endpoint for this study is the mean change from baseline (CFB) in the study eye in ocular surface fluorescein staining score according to a scale from 0 to 15, combining corneal, nasal and temporal bulbar conjunctival fluorescein staining, each graded 0 to 5, according to the Oxford Scheme
Secondary Outcome Measures
- Total ocular fluorescein staining score at Visit 5 [Baseline (Day 0), Visit 5 (Day 90)]
Mean CFB in the study eye in total ocular surface fluorescein staining score
- Fluorescein staining score per area [Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)]
Mean CFB in the study eye in fluorescein staining score for each area (cornea, nasal conjunctiva and temporal conjunctiva)
- TFBUT [Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)]
Mean CFB in the study eye in tear film break-up time (TFBUT)
- Quality of Life questionnaire [Baseline (Day 0), Visit 5 (Day 90)]
Evolution from baseline of Ocular Surface Disease-Quality of Life (OSD-QoL®) questionnaire scores
- Dry eye symptoms [Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)]
Mean CFB in the global sum score of dry eye symptoms: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 to 4
- Schirmer test [Baseline (Day 0), Visit 4 (Day 28)]
Mean CFB in the study eye in volume of tear fluid secretion as assessed by the unanaesthetized Schirmer test
- Questionnaire of daily frequency of instillations [through study completion, an average of 3 months]
Daily frequency of investigational eye drop instillations as reported in subject diary
Other Outcome Measures
- Adverse events questionnaire [through study completion, an average of 3 months]
Occurrence rates of ocular and non-ocular treatment emergent adverse events (TEAEs)
- Visual acuity measurement [Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)]
Visual acuity measurement using Monoyer scale
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects of legal age (at least 18) and able to read, understand, and provide written voluntary informed consent on the Ethics Committee (EC) approved Informed Consent Form
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Subjects able and willing to comply with all treatment and follow-up and study procedures
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Subjects who have been using tear substitutes for at least 2.5 months prior to inclusion, and who will 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
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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
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Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca :
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"Tear break-up time of 10 sec (mean of 3 measurements) at both screening visit and inclusion visit"
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"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"
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Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes
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Subjects with no systemic treatment or who are receiving stable systemic treatment (unchanged for 1 month or longer)
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For Female subjects, they must fall into 1 of the following categories:
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"Post-menopausal"
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"Surgically sterile"
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"Using birth control method throughout the duration of the study"
- For Female subjects who are of childbearing potential (i.e. who are not post-menopausal or not surgically sterile), they must have a negative urine pregnancy test result at screening
Exclusion Criteria:
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Subjects with severe blepharitis
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Subjects who have severe ocular dryness accompanied by 1 of the following:
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"Lid abnormality (except mild or moderate blepharitis)"
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"Corneal disease"
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"Ocular surface metaplasia"
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"Filamentary keratitis"
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"Corneal neovascularization"
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Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start
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Subjects who have received ocular surgery, including laser surgery, in either eye within 180 days prior to study start
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Subjects with a history of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
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Subjects with a history of ocular allergic disease or ocular herpes within 1 year prior to study start
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Subjects with a history of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
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Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART
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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
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Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
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Subjects expected to receive ocular therapy during the study
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Subjects treated with topical ocular steroidal or non-steroidal anti-inflammatory medication within 30 days prior to study start
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Subjects expected to receive ocular therapy with immunosuppressants (eg, cyclosporine) during the study or who have used ocular immunosuppressants within 90 days prior to study start
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Subjects who have received occlusion therapy with non resorbable lacrimal or punctum plugs within 90 days prior to study start or subjects with resorbable plugs
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Subjects who have received or who are planned to receive therapy such as LipiFlow® or BlephEx®
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Females who are breastfeeding
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Kremlin-Bicêtre | Le Kremlin-Bicêtre | France | 94270 |
Sponsors and Collaborators
- Laboratoire Chauvin
Investigators
- Study Director: Raphaele Siou Mermet, MD, Laboratoire Chauvin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-A01099-44