This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye Identifier:
First received: November 28, 2006
Last updated: November 20, 2016
Last verified: November 2016
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 Blind (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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00405431

United States, Pennsylvania
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Principal Investigator: Marlene R. Moster, MD Wills Eye Glaucoma Research Center
  More Information

Responsible Party: Marlene Moster, MD, Attending Surgeon, Wills Eye Identifier: NCT00405431     History of Changes
Other Study ID Numbers: IRB #03-598
Study First Received: November 28, 2006
Last Updated: November 20, 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
conjunctival inflammation

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Lubricant Eye Drops
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 processed this record on July 19, 2017