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

• ClinicalTrials.gov Identifier: NCT03368339
• Recruitment Status: Completed
• First Posted: December 11, 2017
• Last Update Posted: January 29, 2020
• Sponsor: Realm Therapeutics, Inc.
• Information provided by (Responsible Party): Realm Therapeutics, Inc.

Study Description

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®).

Condition or disease	Intervention/treatment	Phase
Allergic Conjunctivitis	Drug: PR013 (0.045%); Drug: PR013 (0.06%); Drug: Vehicle	Phase 2

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®)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-Masked
• Primary Purpose: Treatment
• Official Title: 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®)
• Actual Study Start Date: December 10, 2017
• Actual Primary Completion Date: January 21, 2018
• Actual Study Completion Date: January 28, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PR013 topical Ophthalmic Drops (0.045%); topical Ophthalmic Drops (0.045%)	Drug: PR013 (0.045%); PR013 topical Ophthalmic Drops (0.045%); Other Name: HOCl
Active Comparator: PR013 topical Ophthalmic Drops (0.06%); topical Ophthalmic Drops (0.06%)	Drug: PR013 (0.06%); PR013 topical Ophthalmic Drops (0.06%); Other Name: HOCl
Placebo Comparator: Vehicle; Placebo	Drug: Vehicle; Vehicle

Outcome Measures

Primary Outcome Measures :

1. Ocular itching evaluated by the subject [ Time Frame: [Time Frame: Efficacy assessment period (Day 7 through Day 8)] ]
   The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale
2. Conjunctival redness evaluated by the Investigator [ Time Frame: [Time Frame: Efficacy assessment period (Day 7 through Day 8)] ]
   Ora Calibra(TM) Ocular Hyperemia Scale

Eligibility Criteria

• Ages Eligible for Study: 10 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

Principal Investigator

Philadelphia, Pennsylvania, United States, 19148

Sponsors and Collaborators

Realm Therapeutics, Inc.

Investigators

• Study Chair: Alessandra Cesano, MD; Essa Pharma

More Information

• Responsible Party: Realm Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03368339
• Other Study ID Numbers: 17-100-0007
• First Posted: December 11, 2017
• Last Update Posted: January 29, 2020
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Conjunctivitis; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases