Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery? - Full Text View

Sponsors and Collaborators:	Wills Eye Allergan
Information provided by:	Wills Eye
ClinicalTrials.gov Identifier:	NCT00405431

Purpose

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.

Condition	Intervention
Glaucoma	Drug: Restasis Drug: Endura (artificial tears)

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Cyclosporin Cyclosporine Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery

Further study details as provided by Wills Eye:

Primary Outcome Measures:

intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ocular inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	March 2004
Study Completion Date:	November 2007
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients received restasis eyedrops during 6 month post-operative period	Drug: Restasis 1 drop in study eye twice a day X 6 months
2: Placebo Comparator Patients receive artificial tears (Endura) during 6 month post-operative period	Drug: Endura (artificial tears) 1 drop in study eye twice a day X 6 months

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with uncontrolled glaucoma scheduled for filtering surgery

Exclusion Criteria:

Under 18 years of age
Unable to understand informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405431

Locations

United States, Pennsylvania
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Wills Eye

Allergan

Investigators

Principal Investigator:

Marlene R. Moster, MD

Wills Eye Glaucoma Research Center

More Information

Responsible Party:	Wills Eye Glaucoma Service ( Marlene R. Moster, MD )
Study ID Numbers:	IRB #03-598
Study First Received:	November 28, 2006
Last Updated:	February 24, 2008
ClinicalTrials.gov Identifier:	NCT00405431
Health Authority:	United States: Institutional Review Board

Keywords provided by Wills Eye:

glaucoma filtering surgery
restasis
conjunctival inflammation

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Glaucoma
Miconazole
Eye Diseases
Tioconazole

Tetrahydrozoline
Cyclosporins
Hypertension
Ocular Hypertension
Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009