A Study to Evaluate the Performance and Safety of Artelac Rebalance® Versus Vismed in the Management of Dry Eye
Study Details
Study Description
Brief Summary
The objective of this investigation is to show that the performance of Artelac Rebalance eye drops is non-inferior to that of Vismed eye drops in subjects with moderate to severe dry eye, and to assess the safety of Artelac Rebalance after a 90-day (± 10 day) treatment administered 3 to 5 times per day.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Artelac Rebalance and Vismed are in compliance with European Directives (CE marked) products in the European Union (EU).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Artelac Rebalance Artelac Rebalance ophthalmic solution contains 0.15% hyaluronic acid, is unpreserved and presented in single dose units with a fill volume of 0.5 mL. |
Device: Artelac Rebalance
Instill 1 drop of the Artelac Rebalance eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.
|
| Active Comparator: Vismed Vismed ophthalmic solution, contains 0.18% sodium hyaluronate, is unpreserved and presented in single dose units with a fill volume of 0.3 mL. |
Device: Vismed
Instill 1 drop of the Vismed eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.
|
Outcome Measures
Primary Outcome Measures
- Combined Ocular Surface Staining Score [Mean change from baseline (CFB) to visit 4 (day 28)]
Total combined ocular surface staining grade of 0-15 combining corneal fluorescein staining score, nasal and temporal bulbar conjunctiva lissamine green staining score (each graded 0-5 on the Oxford Scheme) in the study eye.
Secondary Outcome Measures
- Combined Ocular Surface Staining Score [Mean CFB to visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)]
Mean CFB in the study eye at Visits 3, 4 and 5 in total combined ocular surface staining score.
- Corneal Fluorescein Staining Score [Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)]
Mean CFB in the study eye in corneal fluorescein staining score at each follow-up visit
- Nasal Conjunctival Lissamine Green Staining [Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)]
Mean CFB in the study eye in nasal conjunctival lissamine green staining at each follow-up visit.
- Temporal Conjunctival Lissamine Green Staining [Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)]
Mean CFB in the study eye in temporal conjunctival lissamine green staining at each follow-up visit
- Tear Film Break-up Time [Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)]
Mean CFB in the study eye in tear film break-up time (TFBUT) at each follow-up visit.
- Study Drop Sensation [Each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)]
Study drop sensation, as reported by subject in subject diary
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use preservative-free ART (Artelac® UNO CL hypromellose 0.32% w/v eye drops, single dose unit) up to 6 times a day for at least 2 weeks immediately prior to randomization
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Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca at 2 consecutive visits (Visit 1[Screening] and Visit 2 [Randomization])
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Schirmer test without anesthesia of ≤ 9 mm/5min
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Tear break-up time of ≤ 10sec (mean of 3 measurements)
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Total ocular surface staining score ≥ 4 and ≤ 9. This assessment combines corneal fluorescein staining and nasal and temporal bulbar conjunctival lissamine green 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 (Snellen E chart) in both eyes
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Subjects who are receiving stable systemic treatment (unchanged for 1 month or longer)
Exclusion Criteria:
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Subjects with moderate or 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 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
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Subjects with planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of Visit 1 (Screening) or 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 lacrimal or punctum plugs within 90 days prior to study start
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Helmut Allmeier, PhD, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 810