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

NCT01791426 | Withdrawn

• 1 other identifier: 810
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 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 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 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 at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)

Study Arms (2)

Artelac Rebalance

EXPERIMENTAL

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

Vismed

ACTIVE COMPARATOR

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

Interventions

Artelac Rebalance DEVICE

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

Artelac Rebalance

Vismed DEVICE

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

Vismed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Helmut Allmeier, PhD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 15, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 11, 2013

Record last verified: 2013-10