Trial | NCT00405457  Report issue

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cyclosporine ...

  • Study Participants

    50
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.
Study Started
Nov 30
2006
Primary Completion
Jan 31
2008
Study Completion
Jan 31
2008
Last Update
Feb 22
2010
Estimate

Drug Restasis, Optive Tears

Restasis and Optive Tears use twice daily more frequently if needed

A Other

Criteria 

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
No Results Posted