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

Glaucoma Clinical Trial

Official title:

Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405431
• Other study ID #: IRB #03-598
• Status: Completed
• Phase: N/A
• First received: November 28, 2006
• Last updated: November 20, 2016
• Start date: March 2004
• Est. completion date: November 2007

Study information

• Verified date: November 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2007
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with uncontrolled glaucoma scheduled for filtering surgery

Exclusion Criteria:

• Under 18 years of age

• Unable to understand informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Restasis
1 drop in study eye twice a day X 6 months
• Endura (artificial tears)
1 drop in study eye twice a day X 6 months

Locations

Country	Name	City	State
United States	Wills Eye Glaucoma Service	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Exp Ophthalmol. 2009 Dec;37(9):842-8. doi: 10.1111/j.1442-9071.2009.02134.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure		6 months	No
Secondary	ocular inflammation		6 months	No