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Effect of Different Concentrations of 1334H on Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01320553
First received: March 18, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: 1334 H 0.15%
Drug: 1334 H-0.3%
Drug: 1334 H-0.45%
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Masked, Randomized, Vehicle Controlled Evaluation of the of 1334H 0.15%, 0.3%, and 0.45% Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Resource links provided by NLM:


Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Ocular itching and conjunctival redness at defined timepoints [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ciliary and episcleral redness evaluated by the investigator [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1334 H 0.15%
1334H 0.15% eye drops will be administered in both eyes at 3 occasions
Drug: 1334 H 0.15%
1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions
Experimental: 1334 H-0.3%
1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
Drug: 1334 H-0.3%
1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
Experimental: 1334 H-0.45%
1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
Drug: 1334 H-0.45%
1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
Placebo Comparator: Placebo
Placebo eye drops (solution)will be administered in both eyes at 3 occasions
Drug: Placebo
Placebo eye drops (solution)will be administered in both eyes at 3 occasions

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320553

Locations
United States, Massachusetts
ORA Inc
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01320553     History of Changes
Other Study ID Numbers: CLR_02_11
Study First Received: March 18, 2011
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014