Glaucoma
Conditions
Keywords
glaucoma filtering surgery, restasis, conjunctival inflammation
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.
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.
Interventions
DRUGRestasis
1 drop in study eye twice a day X 6 months
DRUGEndura (artificial tears)
1 drop in study eye twice a day X 6 months
Sponsors
Allergan
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intraocular pressure | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| ocular inflammation | 6 months |
Countries
United States
Outcome results
None listed