Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

Study Overview
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Brief Summary
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The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older.

Official Title
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Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: SPARC1102 I
* Drug: SPARC1102 II
* Drug: SPARC1102 III
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC1102 I<br>1334H 0.15% eye drops will be administered in both eyes at 3 occasions | Drug: SPARC1102 I<br>* SPARC1102 I will be administered in both eyes<br>|
| Experimental: SPARC1102 II<br>1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions | Drug: SPARC1102 II<br>* SPARC1102 II will be administered in both eyes<br>|
| Experimental: SPARC1102 III<br>1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions | Drug: SPARC1102 III<br>* SPARC1102 III will be administered in both eyes<br>|
| Placebo Comparator: Vehicle<br>Placebo eye drops (solution)will be administered in both eyes at 3 occasions | Drug: Vehicle<br>* Vehicle will be administered in both eyes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching | 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. | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ciliary Redness Evaluated by the Investigator | 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. | Up to 4 weeks |