Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery?

Wills Eye

Status: Completed

Conditions: Glaucoma

Treatments: Drug: Endura (artificial tears); Drug: Restasis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00405431

IRB #03-598

Details and patient eligibility

About

The purpose of this study is to determine whether reducing inflammation of the surface of the eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase patient comfort.

Full description

Continued use of glaucoma drops can alter the outer surface of the eye and result in swelling and irritation, changing the structure of the eye. This structural change has been found to be a significant risk factor for the failure of glaucoma surgery. A comparison of how well patients do after glaucoma surgery depending on whether they use Restasis (the only prescription medication approved by the FDA for treating dry eye) or artificial tears (which can be purchased without a prescription) for 6 months following their surgery.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with uncontrolled glaucoma scheduled for filtering surgery

Exclusion criteria

• Under 18 years of age
• Unable to understand informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Patients received restasis eyedrops during 6 month post-operative period

Treatment:

Drug: Restasis

2

Placebo Comparator group

Description:

Patients receive artificial tears (Endura) during 6 month post-operative period

Treatment:

Drug: Endura (artificial tears)