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

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ClinicalTrials.gov Identifier: NCT01384266
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : June 29, 2017
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Stephen S. Lane, MD, 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.

Condition or disease
Intraocular Inflammation

Study Type : Observational
Actual Enrollment : 90 participants
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
Study Start Date : May 2010
Primary Completion Date : July 2011
Study Completion Date : November 2011


Group/Cohort
Subjects undergoing Cataract Surgery
Subjects undergoing routine cataract surgery



Primary Outcome Measures :
  1. Intraocular inflammation grading [ Time Frame: Day 21 Post-op ]
    Slit Lamp examination will be done at each visit to grade intraocular inflammation


Secondary Outcome Measures :
  1. Intraocular pressure spikes [ Time Frame: Day 21 post-op ]
    Intraocular pressure(IOP) will be measured at each visit.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384266


Locations
United States, Kentucky
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
United States, Minnesota
Associated Eye Care
Stillwater, Minnesota, United States, 55082
Sponsors and Collaborators
Associated Eye Care, Minnesota
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Stephen S Lane, MD Associated Eye Care

Responsible Party: Stephen S. Lane, MD, Prinicipal Investigator, Associated Eye Care, Minnesota
ClinicalTrials.gov Identifier: NCT01384266     History of Changes
Other Study ID Numbers: AEC-001
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017

Keywords provided by Stephen S. Lane, MD, Associated Eye Care, Minnesota:
Intraocular Inflammation following routine Cataract Surgery

Additional relevant MeSH terms:
Inflammation
Cataract
Uveitis
Pathologic Processes
Lens Diseases
Eye Diseases
Uveal Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol Etabonate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Allergic Agents