Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

Recruitment & Eligibility

Inclusion Criteria

Signed informed consent form and HIPAA document
Willing and able to comply with all study procedures
Be at least 10 years of age at the time of enrollment
LogMar 0.7 or better, in each eye
History of ocular allergies, and a positive skin and ocular allergic reaction to allergens
A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria

have known contraindications or sensitivities to the use of any of the study medications(s) or their 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 a current diagnosis or history of open angle glaucoma or ocular hypertension;
have had ocular surgical intervention within three (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 progressive retinal disease;
have the presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit;
manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at screening or during study
have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study

Arm && Interventions

Group	Intervention	Description
SPARC1102 I	SPARC1102 I	1334H 0.15% eye drops will be administered in both eyes at 3 occasions
SPARC1102 II	SPARC1102 II	1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
SPARC1102 III	SPARC1102 III	1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
Vehicle	Vehicle	Placebo eye drops (solution)will be administered in both eyes at 3 occasions

Primary Outcome Measures

Name	Time	Method
Ocular Itching	Up to 28 days	Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5.

Secondary Outcome Measures

Name	Time	Method
Ciliary Redness Evaluated by the Investigator	Up to 4 weeks	Ciliary redness and episcleral redness were evaluated by the investigator at 7, 15, and 20 minutes post-CAC using a 4-point (0 indicating none and 4 indicating extremely severe i.e. large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) scale with half-unit (1-step) increments allowed.