Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT02242032
Brief 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.
Study:
NCT02242032
Study Brief:
Protocol Section:
NCT02242032