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Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis

NCT03368339 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-01-29

No results posted yet for this study

Summary

To evaluate the efficacy and safety of PR013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®).

Conditions

  • Allergic Conjunctivitis

Interventions

DRUG

PR013 (0.045%)

PR013 topical Ophthalmic Drops (0.045%)

DRUG

PR013 (0.06%)

PR013 topical Ophthalmic Drops (0.06%)

DRUG

Vehicle

Vehicle

Sponsors & Collaborators

  • Realm Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Alessandra Cesano, MD · Essa Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-10
Primary Completion
2018-01-21
Completion
2018-01-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368339 on ClinicalTrials.gov