Efficacy and Safety of a New Multi-Dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Information source: Innovative Medical
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dry Eye
Intervention: Restasis, Optive Tears (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Innovative Medical Official(s) and/or principal investigator(s):
David Hardten, MD, Principal Investigator, Affiliation: Minnesota Eye Consultants
Overall contact:
melissa Earl, Phone: 951-786-0403, Email: m.earl@imedsonline.com
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Primary outcome: efficacy
Secondary outcome: dry eye symptoms
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
melissa Earl, Phone: 951-786-0403, Email: m.earl@imedsonline.com
Minnesota Eye Consultants, Minneapolis, Minnesota 55404, United States; Recruiting
David Hardten, MD, Phone: 612-813-3631, Email: drhardten@mneye.com
Additional Information
Starting date: November 2006
Ending date: January 2008
Last updated: September 23, 2008
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