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

Completed · Phase 4

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT00399061

Run by

Innovative Medical

People needed

55

Starts

2006-11-01

Expected to finish

2008-09-01

Last updated by the study team

2008-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• · 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

You may not qualify if…

• · 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

Where it is running

• Dr. Schultze — Slingerlands, New York, United States

Full record on ClinicalTrials.gov

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