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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye
• Intervention / Treatment: Device: Artelac Rebalance; Device: Vismed

Detailed Description

Artelac Rebalance and Vismed are in compliance with European Directives (CE marked) products in the European Union (EU).

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined Ocular Surface Staining Score	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.	Mean change from baseline (CFB) to visit 4 (day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined Ocular Surface Staining Score	Mean CFB in the study eye at Visits 3, 4 and 5 in total combined ocular surface staining score.	Mean CFB to visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
Corneal Fluorescein Staining Score	Mean CFB in the study eye in corneal fluorescein staining score at each follow-up visit	Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
Nasal Conjunctival Lissamine Green Staining	Mean CFB in the study eye in nasal conjunctival lissamine green staining at each follow-up visit.	Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
Temporal Conjunctival Lissamine Green Staining	Mean CFB in the study eye in temporal conjunctival lissamine green staining at each follow-up visit	Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
Tear Film Break-up Time	Mean CFB in the study eye in tear film break-up time (TFBUT) at each follow-up visit.	Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
Study Drop Sensation	Study drop sensation, as reported by subject in subject diary	Each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Helmut Allmeier, PhD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): October 11, 2013
• Last Update Submitted That Met QC Criteria: October 10, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 810 (Other Identifier: Altus/Alnara)