NCT02242032

Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease

A Double-Masked, Randomized, Placebo-Controlled Dose Escalation Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Parion Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of P-321 Ophthalmic Solution in subjects with mild to moderate dry eye disease.

Detailed description

This is a single-center, dose escalation, randomized, double-masked, placebo-controlled, Phase 1/2a trial designed to evaluate the safety and tolerability of P-321 Ophthalmic Solution in subjects with mild to moderate dry eye for up to 4-weeks of treatment and up to 8 scheduled in clinic visits. This study will conduct a consecutive dose escalation of the following concentrations of P-321 Ophthalmic Solution given two times a day via ocular instillation: 0.0005% (Cohort 1), 0.0015% (Cohort 2), 0.005% (Cohort 3), and 0.01% (Cohort 4). Up to 48 subjects will be enrolled in four consecutive cohorts. Subjects will be randomized to P-321 Ophthalmic Solution or placebo in a 3:1 ratio. Safety and tolerability assessments, drug plasma concentrations and drug urine concentrations will be evaluated throughout the study in all cohorts.

Conditions

• Dry Eye Disease

Interventions

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

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-09-16
• Last updated: 2015-05-04

Locations

1 site across 1 country: United States