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

NCT ID: NCT01791426

Last Updated: 2013-10-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-10-31

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).

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Artelac Rebalance

Intervention Type: DEVICE

Instill 1 drop of the Artelac Rebalance eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.

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.

Group Type: ACTIVE_COMPARATOR

Vismed

Intervention Type: DEVICE

Instill 1 drop of the Vismed eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.

Interventions

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.

Intervention Type: DEVICE

Vismed

Instill 1 drop of the Vismed eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.

Intervention Type: DEVICE

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helmut Allmeier, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Countries

France

Other Identifiers

810

Identifier Type: -

Identifier Source: org_study_id