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

Bausch + Lomb

Status

Withdrawn

Conditions

Dry Eye

Treatments

Device: Vismed

Device: Artelac Rebalance

Study type

Interventional

Funder types

Industry

Identifiers

NCT01791426

810 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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