Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Vehicle; Drug: SPARC1102 II; Drug: SPARC1102 I; Drug: SPARC1102 III

Study type: Interventional

Funder types: Industry

Identifiers

NCT01320553

CLR_11_02

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 4 patient groups, including a placebo group

SPARC1102 I

Experimental group

Description:

1334H 0.15% eye drops will be administered in both eyes at 3 occasions

Treatment:

Drug: SPARC1102 I

SPARC1102 II

Experimental group

Description:

1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions

Treatment:

Drug: SPARC1102 II

SPARC1102 III

Experimental group

Description:

1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions

Treatment:

Drug: SPARC1102 III

Vehicle

Placebo Comparator group

Description:

Placebo eye drops (solution)will be administered in both eyes at 3 occasions

Treatment:

Drug: Vehicle