Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Phase 4
Completed
- Conditions
- Dry Eye
- Interventions
- Drug: Restasis, Optive Tears
- Registration Number
- NCT00405457
- Lead Sponsor
- Innovative Medical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
-
· 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
Exclusion Criteria
-
· 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Restasis, Optive Tears -
- Primary Outcome Measures
Name Time Method efficacy 1 yr 3 months
- Secondary Outcome Measures
Name Time Method dry eye symptoms 1 yr 3 months
Trial Locations
- Locations (1)
Minnesota Eye Consultants
🇺🇸Minneapolis, Minnesota, United States