NCT04884217

Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: PharmaDax Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease

Detailed description

Pro-ocular™ 1% topical gel his demonstrated efficacy in rapidly reducing or eliminating dry eye symptoms, and after multiple doses, the signs and symptoms of ocular surface disease including dry eye disease. Study DE-2 is single center, randomized, double-masked, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks for treatment of Dry Eye Disease. The approximately 80 subjects will be randomized 1:1, active drug:placebo.

Conditions

• Dry Eye Syndrome
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	Pro-ocular™ Topical Gel	Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily
DRUG	Placebo Topical Gel	Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-10-30
• Completion: 2021-12-30
• First posted: 2021-05-12
• Last updated: 2021-05-14

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study