Completed
PHASE3
INTERVENTIONAL
NCT02786901
LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.
Detailed Description
A Phase 3, Multi-Center, Double-Masked, Vehicle Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.
Interventions
Name:
Loteprednol Etabonate Ophthalmic Gel dosed TID
Type:
DRUG
Description:
Gel
Name:
Loteprednol Etabonate Ophthalmic Gel dosed BID
Type:
DRUG
Description:
Gel
Name:
Vehicle Gel
Type:
DRUG
Description:
Gel
Primary Outcomes
Measure:
Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8)
TimeFrame:
8 days
Description:
Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye.
Measure:
Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8)
TimeFrame:
8 days
Description:
Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0.
Trial Information
NCT ID
NCT02786901
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Bausch & Lomb Incorporated
Last Updated
December 15, 2025