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

Sponsor
Wills Eye (Other)
Overall Status
Completed
CT.gov ID
NCT00405431
Collaborator
Allergan (Industry)
43
Enrollment
1
Location
2
Arms
44
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
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
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jun 1, 2005
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Endura

    		•

    Outcome Measures

    Primary Outcome Measures

    1. intraocular pressure [6 months]

    Secondary Outcome Measures

    1. ocular inflammation [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marlene Moster, MD, Attending Surgeon, Wills Eye
    ClinicalTrials.gov Identifier:
    NCT00405431
    Other Study ID Numbers:
    • IRB #03-598
    First Posted:
    Nov 30, 2006
    Last Update Posted:
    Nov 22, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Marlene Moster, MD, Attending Surgeon, Wills Eye
    glaucoma filtering surgery
    restasis
    conjunctival inflammation
    Additional relevant MeSH terms:
    Glaucoma
    Lubricant Eye Drops

    Study Results

    No Results Posted as of Nov 22, 2016