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

Pain Clinical Trial

Official title:

A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060072
• Other study ID #: 577
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2010
• Last updated: December 8, 2011
• Start date: February 2010
• Est. completion date: October 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 to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: October 2010
• Est. primary completion date: September 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.

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 visual acuity (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:
• Loteprednol etabonate
Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
• Vehicle of Loteprednol Etabonate
Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.

Locations

Country	Name	City	State
United States	Bausch & Lomb	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.	Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells	Visit 5 (Postoperative day 8)	No
Primary	Grade 0 Pain	Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain	Visit 5 (Postoperative day 8)	No
Secondary	Resolution of Anterior Chamber Cells	Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells	Visit 4-7 (postoperative day 3-18)	No
Secondary	Grade 0 Pain	Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain	Visits 4-7 (Postoperative days 3-18)	No
Secondary	Resolution of Anterior Chamber Flare	Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.	Visit 4-7 (postoperative day 3-18)	No