A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:6/30/2017
Start Date:May 2010
End Date:November 2011

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A Randomized, Multicenter, Masked Evaluation of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate for the Treatment of Inflammation Following Cataract Surgery

Patients are routinely given steroid eye drops following cataract surgery. This study will
compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used
following cataract surgery. Patients will be randomly assigned to one drop or the other, and
evaluated for inflammation and intraocular pressure as part of the comparison. The study
Doctor will be masked as to which drop the patient receives to avoid bias.


Inclusion Criteria:

- Subjects age 18 and older undergoing routine cataract surgery.

Exclusion Criteria:

1. Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy,
cornea or vitreous opacities that would interfere with visual acuity.

2. Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or
active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or
Limbal Relaxing Incision(LRIs) will be allowed.

3. Subjects with previous ocular trauma or intraocular surgery

4. Subjects with sensitivities to steroids.

5. Women who are not post-menopausal or are of child bearing potential will be excluded.

6. Intraoperative complications during surgery including posterior capsule rupture and
vitreous loss

7. Subjects with best visual potential in the fellow eye worse than 20/60

8. Subjects who are expected to require concurrent ocular or systemic therapy with
non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines,
or decongestants within 2 days prior to or during the 21 days following surgery.
(Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted.

9. Subjects who are expected to require concurrent ocular or systemic corticosteroids,
immunosuppressants (including Restasis) within 14 days prior to or 21 days following
surgery
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Edgewood, Kentucky 41017
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Stillwater, Minnesota 55082
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Stillwater, MN
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