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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01791426
• Other study ID #: 810
• Status: Withdrawn
• Phase: N/A
• First received: February 4, 2013
• Last updated: October 10, 2013
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No