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

NCT01384266 | Completed

• 1 other identifier: AEC-001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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

Keywords

Intraocular Inflammation following routine Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Intraocular inflammation grading

  Slit Lamp examination will be done at each visit to grade intraocular inflammation

  Day 21 Post-op

Secondary Outcomes (1)

• Intraocular pressure spikes

  Day 21 post-op

Study Arms (1)

Subjects undergoing Cataract Surgery

Subjects undergoing routine cataract surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eye Clinic

You may qualify if:

• Subjects age 18 and older undergoing routine cataract surgery.

You may not qualify if:

• Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity.
• 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.
• Subjects with previous ocular trauma or intraocular surgery
• Subjects with sensitivities to steroids.
• Women who are not post-menopausal or are of child bearing potential will be excluded.
• Intraoperative complications during surgery including posterior capsule rupture and vitreous loss
• Subjects with best visual potential in the fellow eye worse than 20/60
• 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.
• Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery

Sponsors & Collaborators

• Associated Eye Care, Minnesota: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (2)

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Associated Eye Care

Stillwater, Minnesota, 55082, United States

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Stephen S Lane, MD

  Associated Eye Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: June 29, 2011
• Study Start: May 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 29, 2017

Record last verified: 2017-06

Locations

US (2)