Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovative Medical
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• · Males or females > 18 years old

• Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)

• At least Grade 2 conjunctival staining

• Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

• · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)

• Current use of topical cyclosporine

• Known contraindications to any study medication or ingredients

• Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.

• Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)

• Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)

• Ocular surgery within the past 3 months,

• Active ocular allergies