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OpenTrials
Completed

NCT Number: NCT01320553

Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ORA Inc

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARC1102 I

Drug

SPARC1102 I will be administered in both eyes

SPARC1102 II

Drug

SPARC1102 II will be administered in both eyes

SPARC1102 III

Drug

SPARC1102 III will be administered in both eyes

Vehicle

Drug

Vehicle will be administered in both eyes

Primary outcomes

  1. Ocular Itching

    Time frame: 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 outcomes

  1. Ciliary Redness Evaluated by the Investigator

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 22, 2011
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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