Clinical trial NCT01791426: A Study to Evaluate the Performance and Safety of Artelac Rebalance® Versus Vismed in the Management of Dry Eye
Official title: A Study to Evaluate the Performance and Safety of Artelac Rebalance® Versus Vismed in the Management of Dry Eye
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dry Eye
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

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

Primary outcomes:
measure: Combined Ocular Surface Staining Score
timeFrame: Mean change from baseline (CFB) to visit 4 (day 28)
Secondary outcomes:
measure: Combined Ocular Surface Staining Score
timeFrame: Mean CFB to visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
measure: Corneal Fluorescein Staining Score
timeFrame: Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
measure: Nasal Conjunctival Lissamine Green Staining
timeFrame: Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
measure: Temporal Conjunctival Lissamine Green Staining
timeFrame: Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
measure: Tear Film Break-up Time
timeFrame: Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
measure: Study Drop Sensation
timeFrame: Each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Helmut Allmeier, PhD
role: STUDY_DIRECTOR
References: