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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Patients received restasis eyedrops during 6 month post-operative period |
|
| 2 | Placebo Comparator | Patients receive artificial tears (Endura) during 6 month post-operative period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restasis | Drug | 1 drop in study eye twice a day X 6 months |
| |
| Endura (artificial tears) |
| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ocular inflammation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene R. Moster, MD | Wills Eye Glaucoma Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Glaucoma Service | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20092592 | Result | 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. |
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manuscript has been published.
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Drug |
1 drop in study eye twice a day X 6 months |
|
|
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |