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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03368339
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Realm Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE December 11, 2017
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE December 10, 2017
Actual Primary Completion Date January 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
  • 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
  • Conjunctival redness evaluated by the Investigator [ Time Frame: [Time Frame: Efficacy assessment period (Day 7 through Day 8)] ]
    Ora Calibra(TM) Ocular Hyperemia Scale
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
Ocular itching evaluated by the subject [ Time Frame: Day 3 through Day 15 ]
The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis
Official Title  ICMJE 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®)
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®)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-Masked
Primary Purpose: Treatment
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE
  • Drug: PR013 (0.045%)
    PR013 topical Ophthalmic Drops (0.045%)
    Other Name: HOCl
  • Drug: PR013 (0.06%)
    PR013 topical Ophthalmic Drops (0.06%)
    Other Name: HOCl
  • Drug: Vehicle
    Vehicle
Study Arms  ICMJE
  • Active Comparator: PR013 topical Ophthalmic Drops (0.045%)
    topical Ophthalmic Drops (0.045%)
    Intervention: Drug: PR013 (0.045%)
  • Active Comparator: PR013 topical Ophthalmic Drops (0.06%)
    topical Ophthalmic Drops (0.06%)
    Intervention: Drug: PR013 (0.06%)
  • Placebo Comparator: Vehicle
    Placebo
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2019)
96
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
90
Actual Study Completion Date  ICMJE January 28, 2018
Actual Primary Completion Date January 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03368339
Other Study ID Numbers  ICMJE 17-100-0007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Realm Therapeutics, Inc.
Study Sponsor  ICMJE Realm Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Alessandra Cesano, MD Essa Pharma
PRS Account Realm Therapeutics, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP