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

Intraocular Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384266
• Other study ID #: AEC-001
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: June 28, 2017
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: June 2017
• Source: Associated Eye Care, Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Intraocular Inflammation
• Uveitis

Locations

Country	Name	City	State
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Associated Eye Care	Stillwater	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Associated Eye Care, Minnesota	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular inflammation grading	Slit Lamp examination will be done at each visit to grade intraocular inflammation	Day 21 Post-op
Secondary	Intraocular pressure spikes	Intraocular pressure(IOP) will be measured at each visit.	Day 21 post-op