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

Completed

• Conditions: Intraocular Inflammation

• Registration Number: NCT01384266
• Lead Sponsor: Associated Eye Care, Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-29
• Primary Completion: 2011-07
• Study Completion: 2011-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraocular inflammation grading	Day 21 Post-op	Slit Lamp examination will be done at each visit to grade intraocular inflammation

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure spikes	Day 21 post-op	Intraocular pressure(IOP) will be measured at each visit.

Trial Locations

Locations (2)

Cincinnati Eye Institute; 🇺🇸 Edgewood, Kentucky, United States

Associated Eye Care; 🇺🇸 Stillwater, Minnesota, United States