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Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01010633
First received: November 6, 2009
Last updated: December 8, 2011
Last verified: December 2011

November 6, 2009
December 8, 2011
November 2009
June 2010   (final data collection date for primary outcome measure)
  • Resolution of Anterior Chamber Cells (ACC). [ Time Frame: Visit 5 (Postoperative day 8) ] [ Designated as safety issue: No ]
    Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
  • Grade 0 Pain [ Time Frame: Visit 5 (Postoperative Day 8) ] [ Designated as safety issue: No ]
    Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
Resolution of anterior chamber cells. [ Time Frame: Postoperatve day 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01010633 on ClinicalTrials.gov Archive Site
Resolution of Anterior Chamber Cells. [ Time Frame: At visits 4-7- postoperative day 3, 8,15 & 18 ] [ Designated as safety issue: No ]
Study eyes with complete resolution of anterior chamber cells (ACC)
Resolution of anterior chamber cells. [ Time Frame: At all visits - postoperative day 1, 3, 8,15 & 18 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Not Provided

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Inflammation
  • Pain
  • Drug: Vehicle of Loteprednol Etabonate
    1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
  • Drug: Loteprednol Etabonate
    1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
  • Experimental: Loteprednol Etabonate
    Loteprednol etabonate
    Intervention: Drug: Loteprednol Etabonate
  • Placebo Comparator: Vehicle
    Vehicle of loteprednol etabonate
    Intervention: Drug: Vehicle of Loteprednol Etabonate
Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
406
August 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who are at least 18 years of age.
  • Subjects who are candidates for routine, uncomplicated cataract surgery.
  • Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

  • Subjects who have known hypersensitivity or contraindication to the study drug or components.
  • Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
  • Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
  • Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01010633
576
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Laura Trusso Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP