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

NCT ID: NCT03368339

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-10
• Study Completion Date: 2018-01-28

Brief 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®)

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PR013 topical Ophthalmic Drops (0.045%)

topical Ophthalmic Drops (0.045%)

Group Type: ACTIVE_COMPARATOR

PR013 (0.045%)

Intervention Type: DRUG

PR013 topical Ophthalmic Drops (0.045%)

PR013 topical Ophthalmic Drops (0.06%)

topical Ophthalmic Drops (0.06%)

Group Type: ACTIVE_COMPARATOR

PR013 (0.06%)

Intervention Type: DRUG

PR013 topical Ophthalmic Drops (0.06%)

Vehicle

Placebo

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle

Interventions

PR013 (0.045%)

PR013 topical Ophthalmic Drops (0.045%)

Intervention Type: DRUG

PR013 (0.06%)

PR013 topical Ophthalmic Drops (0.06%)

Intervention Type: DRUG

Vehicle

Vehicle

Intervention Type: DRUG

Other Intervention Names

HOCl; HOCl

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Realm Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandra Cesano, MD

Role: STUDY_CHAIR

Essa Pharma

Locations

Principal Investigator

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

17-100-0007

Identifier Type: -

Identifier Source: org_study_id