NCT04268069

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	PL9643 Ophthalmic Solution	PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.
DRUG	Placebo Ophthalmic Solution	Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Timeline

• Start date: 2020-02-14
• Primary completion: 2020-10-05
• Completion: 2020-10-05
• First posted: 2020-02-13
• Last updated: 2020-11-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study