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Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

NCT01320553•Sun Pharma Advanced Research Company Limited

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.

Eligibility

Age

10 - No limit years

Sex

ALL

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

Locations (1)

ORA Inc

Andover, Massachusetts, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

August 1, 2011

Completion Date

September 1, 2011

Last Updated

June 24, 2016

Enrollment

122

ACTUAL participants

Conditions

Allergic Conjunctivitis

Interventions

SPARC1102 I

DRUG

SPARC1102 II

DRUG

SPARC1102 III

DRUG

Vehicle

DRUG

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

Inclusion Criteria

Exclusion Criteria

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

Tyrosine Allergoid Paediatric and Adult Study

Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis

Dietary Choice for the Management of Cow's Milk Allergy Influences Other Allergic Manifestations