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

NCT ID: NCT01384266

Last Updated: 2017-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Intraocular Inflammation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects undergoing Cataract Surgery

Subjects undergoing routine cataract surgery

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

Associated Eye Care, Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Stephen S. Lane, MD

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen S Lane, MD

Role: PRINCIPAL_INVESTIGATOR

Associated Eye Care

Locations

Cincinnati Eye Institute

Edgewood, Kentucky, United States

Associated Eye Care

Stillwater, Minnesota, United States

Countries

United States

Other Identifiers

AEC-001

Identifier Type: -

Identifier Source: org_study_id