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

NCT03368339 | Completed Phase 2 FDA Drug

• 1 other identifier: 17-100-0007
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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®).

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• Ocular itching evaluated by the subject

  The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale

  [Time Frame: Efficacy assessment period (Day 7 through Day 8)]

• Conjunctival redness evaluated by the Investigator

  Ora Calibra(TM) Ocular Hyperemia Scale

  [Time Frame: Efficacy assessment period (Day 7 through Day 8)]

Study Arms (3)

PR013 topical Ophthalmic Drops (0.045%)

ACTIVE COMPARATOR

topical Ophthalmic Drops (0.045%)

Drug: PR013 (0.045%)

PR013 topical Ophthalmic Drops (0.06%)

ACTIVE COMPARATOR

topical Ophthalmic Drops (0.06%)

Drug: PR013 (0.06%)

Vehicle

PLACEBO COMPARATOR

Placebo

Drug: Vehicle

Interventions

PR013 (0.045%) DRUG

PR013 topical Ophthalmic Drops (0.045%)

Also known as: HOCl

PR013 topical Ophthalmic Drops (0.045%)

PR013 (0.06%) DRUG

PR013 topical Ophthalmic Drops (0.06%)

Also known as: HOCl

PR013 topical Ophthalmic Drops (0.06%)

Vehicle DRUG

Vehicle

Vehicle

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Realm Therapeutics, Inc.: lead

Study Sites (1)

Principal Investigator

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Alessandra Cesano, MD

  Essa Pharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 11, 2017
• Study Start: December 10, 2017
• Primary Completion: January 21, 2018
• Study Completion: January 28, 2018
• Last Updated: January 29, 2020

Record last verified: 2019-08

Locations

US (1)