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Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

Dry Eye Disease Clinical Trial

Official title:
A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of PL9643 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

Clinical Trial Summary

Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.

Clinical Trial Description

The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study. During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04268069
Study type Interventional
Source ORA, Inc.
Contact
Status Completed
Phase Phase 2
Start date February 14, 2020
Completion date October 5, 2020
View Details
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