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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010633
• Other study ID #: 576
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2009
• Last updated: December 8, 2011
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Pain

Intervention

Drug:
• Vehicle of Loteprednol Etabonate
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
• Loteprednol Etabonate
1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.

Locations

Country	Name	City	State
United States	Bausch & Lomb, Inc.	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of Anterior Chamber Cells (ACC).	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.	Visit 5 (Postoperative day 8)	No
Primary	Grade 0 Pain	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.	Visit 5 (Postoperative Day 8)	No
Secondary	Resolution of Anterior Chamber Cells.	Study eyes with complete resolution of anterior chamber cells (ACC)	At visits 4-7- postoperative day 3, 8,15 & 18	No