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Keep this study
Lead
Realm Therapeutics, Inc.
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®)
Age
10–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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
Clareo Health | Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis
