ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03368339
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Realm Therapeutics, Inc.

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: Placebo 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

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

Placebo Comparator: Vehicle Drug: Placebo
Vehicle




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368339


Contacts
Contact: Valerie Crossley 4843212700 Valerie@realmtx.com
Contact: Kathy Goin 4843212700 kgoin@realmtx.com

Locations
United States, Pennsylvania
Principal Investigator Recruiting
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Realm Therapeutics, Inc.
Investigators
Study Director: Christian Peters Realm Therapeutics

Responsible Party: Realm Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03368339     History of Changes
Other Study ID Numbers: 17-100-0007
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

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
Ophthalmic Solutions
Pharmaceutical Solutions