Loading clinical trials...

Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle of PR013 Topical Ophthalmic Drops for the Treatment of Allergic Conjunctivitis Using Conjunctival Allergen Challenge Model (Ora-CAC®)

NCT03368339•Realm Therapeutics, Inc.

View on ClinicalTrials.gov

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®).

Detailed Description

A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of PR013 Topical Ophthalmic Drops (0.045% and 0.06%) Compared to Vehicle of PR013 Topical Ophthalmic Drops for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)

Eligibility

Age

10 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•be at least 10 years of age of either sex and any race
•have a positive history of ocular allergies and a positive skin test reaction to a perennial allergen (cat dander, dog dander, dust mites, cockroaches) and a seasonal allergen (trees, grasses, and/or ragweed) as confirmed by an allergic skin test within the past 24 months.
•have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria

•have known contraindications or sensitivities to the use of the investigational product or any of its components
•have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
•have had ocular surgical intervention within 3 months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 6 months
•have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
•have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
•use any of the disallowed medications\* during the period indicated prior to Visit 1 and during the study
•have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease \[including arrhythmias\] the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens;
•have planned surgery (ocular or systemic) during the trial period or within 30 days after;
•have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial;
•be a female who is currently pregnant, planning a pregnancy, or lactating

Locations (1)

Principal Investigator

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 10, 2017

Primary Completion Date

January 21, 2018

Completion Date

January 28, 2018

Last Updated

January 29, 2020

Enrollment

ACTUAL participants

Conditions

Allergic Conjunctivitis

Interventions

PR013 (0.045%)

DRUG

PR013 (0.06%)

DRUG

Vehicle

DRUG

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

NCT05839938

Allergic Conjunctivitis

View study

ACTIVE_NOT_RECRUITING

Tyrosine Allergoid Paediatric and Adult Study

NCT05186025

Allergic Rhinitis Due to PollenAllergic Conjunctivitis+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

Tyrosine Allergoid Paediatric and Adult Study

Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis

Dietary Choice for the Management of Cow's Milk Allergy Influences Other Allergic Manifestations