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

Sponsor
Realm Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03368339
Collaborator
(none)
96
1
3
1.6
59.6

Study Details

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
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
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 :
Dec 10, 2017
Actual Primary Completion Date :
Jan 21, 2018
Actual Study Completion Date :
Jan 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 Names:
  • 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 Names:
  • HOCl
  • Placebo Comparator: Vehicle

    Placebo

    Drug: Vehicle
    Vehicle

    Outcome Measures

    Primary Outcome Measures

    1. Ocular itching evaluated by the subject [[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: Efficacy assessment period (Day 7 through Day 8)]]

      Ora Calibra(TM) Ocular Hyperemia Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Principal Investigator Philadelphia Pennsylvania United States 19148

    Sponsors and Collaborators

    • Realm Therapeutics, Inc.

    Investigators

    • Study Chair: Alessandra Cesano, MD, Essa Pharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Realm Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03368339
    Other Study ID Numbers:
    • 17-100-0007
    First Posted:
    Dec 11, 2017
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 29, 2020