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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

November 28, 2006
January 25, 2010
March 2004
June 2005   (final data collection date for primary outcome measure)
intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • intraocular pressure
  • number of post operative glaucoma medications
  • patient comfort level
  • conjunctival inflammation
Complete list of historical versions of study NCT00405431 on ClinicalTrials.gov Archive Site
ocular inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery?
Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Glaucoma
  • Drug: Restasis
    1 drop in study eye twice a day X 6 months
    Other Name: Restasis
  • Drug: Endura (artificial tears)
    1 drop in study eye twice a day X 6 months
    Other Name: Endura
  • Active Comparator: 1
    Patients received restasis eyedrops during 6 month post-operative period
    Intervention: Drug: Restasis
  • Placebo Comparator: 2
    Patients receive artificial tears (Endura) during 6 month post-operative period
    Intervention: Drug: Endura (artificial tears)
Fakhraie G, Lopes JF, Spaeth GL, Almodin J, Ichhpujani P, Moster MR. Effects of postoperative cyclosporine ophthalmic emulsion 0.05% (Restasis) following glaucoma surgery. Clin Experiment Ophthalmol. 2009 Dec;37(9):842-8. doi: 10.1111/j.1442-9071.2009.02134.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
November 2007
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with uncontrolled glaucoma scheduled for filtering surgery

Exclusion Criteria:

  • Under 18 years of age
  • Unable to understand informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00405431
IRB #03-598
No
Marlene R. Moster, MD, Wills Eye Glaucoma Service
Wills Eye
Allergan
Principal Investigator: Marlene R. Moster, MD Wills Eye Glaucoma Research Center
Wills Eye
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP