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NCT00405457 Clinical Trial

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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00405457
Other study ID # 5261
Secondary ID
Status Completed
Phase Phase 4
First received November 28, 2006
Last updated February 19, 2010
Start date November 2006
Est. completion date January 2008

Study information
Verified date February 2010
Source Innovative Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Restasis, Optive Tears
Restasis and Optive Tears use twice daily more frequently if needed

Locations
Country Name City State
United States Minnesota Eye Consultants Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary efficacy 1 yr 3 months No
Secondary dry eye symptoms 1 yr 3 months No
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