Status:
COMPLETED
Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis
Lead Sponsor:
Realm Therapeutics, Inc.
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
10+ years
Phase:
PHASE2
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 Con...
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 Tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2018
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03368339
Start Date
December 10 2017
End Date
January 28 2018
Last Update
January 29 2020
Active Locations (1)
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1
Principal Investigator
Philadelphia, Pennsylvania, United States, 19148