NCT03693183

Efficacy Study of Ketorolac and HPMC to Treat Dry Eye

A Double-Masked, Randomized, Single-Center Study Evaluating the Effect of 0.30% Ketorolac/0.80% HPMC, 0.80% HPMC and Vehicle on Symptoms of Dry Eye After Exposure to the Controlled Adverse Environment (CAE)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ketorolac and Hydroxypropyl Methylcellulose are effective in the treatment of Dry Eye.

Detailed description

This is a double masked, randomized study with approximately 45 subjects randomized to one of the three treatment arms at a single site. There are 5 visits over the course of 16 days. Visit 1: Day -7 Visit 2: Day 0 Visit 3: Day 2 Visit 4: Day 7 Visit 5: Day 9

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Ketorolac/HPMC	0.30% Ketorolac/0.80%HPMC Ophthalmic solution administered 4 times per day for 2 days
DRUG	HPMC	0.80% Hydroxypropyl Methylcellulose solution 4 times per day for 2 days
DRUG	Vehicle	Vehicle

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-06-15
• Completion: 2009-06-15
• First posted: 2018-10-02
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study