NCT02831387

Evaluation of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease

Randomized, Double-Masked, Parallel Group Study of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Assessing Safety and Efficacy Over 28 Days

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Parion Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye Symptoms.

Detailed description

This is a multi-center, randomized, double-masked, placebo-controlled, parallel group Phase 2b trial designed to evaluate symptoms and signs in subjects with mild to moderate dry eye disease. Eligible patients, will be treated with placebo during 2-week placebo run-in period. Subjects will then be randomly assigned in a double-masked, 1:1 ratio to either 0.017% P-321 Ophthalmic Solution or placebo TID for 28 days. This study is designed to evaluate the changes in symptoms. Safety will be assessed throughout the study by adverse events.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	P-321 Ophthalmic Solution	P-321 Ophthalmic Solution 0.017%
DRUG	P-321 Ophthalmic Solution placebo	Placebo to match P-321 Ophthalmic Solution

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-07-13
• Last updated: 2018-10-11
• Results posted: 2018-10-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study