Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

NCT ID: NCT01320553

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-09-30

Brief Summary

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SPARC1102 I

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

Group Type: EXPERIMENTAL

SPARC1102 I

Intervention Type: DRUG

SPARC1102 I will be administered in both eyes

SPARC1102 II

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

Group Type: EXPERIMENTAL

SPARC1102 II

Intervention Type: DRUG

SPARC1102 II will be administered in both eyes

SPARC1102 III

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

Group Type: EXPERIMENTAL

SPARC1102 III

Intervention Type: DRUG

SPARC1102 III will be administered in both eyes

Vehicle

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

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle will be administered in both eyes

Interventions

SPARC1102 I

SPARC1102 I will be administered in both eyes

Intervention Type: DRUG

SPARC1102 II

SPARC1102 II will be administered in both eyes

Intervention Type: DRUG

SPARC1102 III

SPARC1102 III will be administered in both eyes

Intervention Type: DRUG

Vehicle

Vehicle will be administered in both eyes

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharma Advanced Research Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ORA Inc

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

CLR_11_02

Identifier Type: -

Identifier Source: org_study_id