A Study to Evaluate the Performance and Safety of Artelac Rebalance® Versus Vismed in the Management of Dry Eye

Not Applicable

Withdrawn

• Conditions: Dry Eye
• Interventions: Device: Artelac Rebalance; Device: Vismed

• Registration Number: NCT01791426
• Lead Sponsor: Bausch & Lomb Incorporated

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).

Study Timeline

• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Study Start: 2013-05
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artelac Rebalance	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.
Vismed	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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.
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.
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
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