Dry Eye
Conditions
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.
Detailed description
Artelac Rebalance and Vismed are in compliance with European Directives (CE marked) products in the European Union (EU).
Interventions
DEVICEArtelac Rebalance
Instill 1 drop of the Artelac Rebalance eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.
DEVICEVismed
Instill 1 drop of the Vismed eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca at 2 consecutive visits (Visit 1\[Screening\] and Visit 2 \[Randomization\]) * Schirmer test without anesthesia of ≤ 9 mm/5min * Tear break-up time of ≤ 10sec (mean of 3 measurements) * 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 * Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Snellen E chart) in both eyes * Subjects who are receiving stable systemic treatment (unchanged for 1 month or longer)
Exclusion criteria
* Subjects with moderate or severe blepharitis * Subjects who have severe ocular dryness accompanied by 1 of the following: * Lid abnormality (except mild blepharitis) * Corneal disease * Ocular surface metaplasia * 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 * Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products * 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 * 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 anti- inflammatory medication within 30 days prior to study start * 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 * Subjects who have received occlusion therapy with lacrimal or punctum plugs within 90 days prior to study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
Outcome results
None listed