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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Wills Eye
ClinicalTrials.gov Identifier:
NCT00405431
First received: November 28, 2006
Last updated: January 25, 2010
Last verified: January 2008
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery

Resource links provided by NLM:


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
Active Comparator: 1
Patients received restasis eyedrops during 6 month post-operative period
Drug: Restasis
1 drop in study eye twice a day X 6 months
Other Name: Restasis
Placebo Comparator: 2
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
Other Name: Endura

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Marlene R. Moster, MD, Wills Eye Glaucoma Service
ClinicalTrials.gov Identifier: NCT00405431     History of Changes
Other Study ID Numbers: IRB #03-598
Study First Received: November 28, 2006
Last Updated: January 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
glaucoma filtering surgery
restasis
conjunctival inflammation

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014