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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00405431
First Posted: November 30, 2006
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Marlene Moster, MD, Wills Eye:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • ocular inflammation [ Time Frame: 6 months ]

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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Moster, MD, Attending Surgeon, Wills Eye
ClinicalTrials.gov Identifier: NCT00405431     History of Changes
Other Study ID Numbers: IRB #03-598
First Submitted: November 28, 2006
First Posted: November 30, 2006
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: manuscript has been published.

Keywords provided by Marlene Moster, MD, Wills Eye:
glaucoma filtering surgery
restasis
conjunctival inflammation

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Lubricant Eye Drops
Cyclosporins
Cyclosporine
Ophthalmic Solutions
Pharmaceutical Solutions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors