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

This study is currently recruiting participants.
Verified June 2011 by Associated Eye Care, Minnesota
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Associated Eye Care, Minnesota
ClinicalTrials.gov Identifier:
NCT01384266
First received: January 13, 2011
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition
Intraocular Inflammation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized, Multicenter, Masked Evaluation of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate for the Treatment of Inflammation Following Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Associated Eye Care, Minnesota:

Primary Outcome Measures:
  • Intraocular inflammation grading [ Time Frame: Day 21 Post-op ] [ Designated as safety issue: No ]
    Slit Lamp examination will be done at each visit to grade intraocular inflammation


Secondary Outcome Measures:
  • Intraocular pressure spikes [ Time Frame: Day 21 post-op ] [ Designated as safety issue: No ]
    Intraocular pressure(IOP) will be measured at each visit.


Estimated Enrollment: 90
Study Start Date: May 2010
Groups/Cohorts
Subjects undergoing Cataract Surgery
Subjects undergoing routine cataract surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Eye Clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384266

Contacts
Contact: Stephen S Lane, MD 651-275-3000 sslane@associatedeyecare.com

Locations
United States, Kentucky
Cincinnati Eye Institute Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Edward J Holland, MD     859-331-9000     eholland@cincinnatieye.com    
Principal Investigator: Edward J Holland, MD            
United States, Minnesota
Associated Eye Care Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Stephen S Lane, MD     651-275-3000     sslane@associatedeyecare.com    
Principal Investigator: Stephen S Lane, MD            
Sponsors and Collaborators
Associated Eye Care, Minnesota
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Stephen S Lane, MD Associated Eye Care
  More Information

No publications provided

Responsible Party: Stephen S. Lane, MD, Associated Eye Care
ClinicalTrials.gov Identifier: NCT01384266     History of Changes
Other Study ID Numbers: AEC-001
Study First Received: January 13, 2011
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Associated Eye Care, Minnesota:
Intraocular Inflammation following routine Cataract Surgery

Additional relevant MeSH terms:
Inflammation
Chorioretinitis
Uveitis
Cataract
Pathologic Processes
Retinitis
Retinal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Uveal Diseases
Uveitis, Posterior
Panuveitis
Lens Diseases
Methylprednisolone acetate
 Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol etabonate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 23, 2013