Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Completed · Phase 4

Conditions studied: Dry Eye

In brief

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Key facts

Study ID

NCT00405457

Run by

Innovative Medical

People needed

50

Starts

2006-11-01

Expected to finish

2008-01-01

Last updated by the study team

2010-02-22

Who can join

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

You may qualify if…

• · Males or females > 18 years old
• Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
• Likely to complete all study visits and able to provide informed consent

You may not qualify if…

• · Patients using Restasis® for less than 3 months.
• 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.
• Other active uncontrolled ocular diseases or uncontrolled systemic disease

Where it is running

• Minnesota Eye Consultants — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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