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Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320553
First Posted: March 22, 2011
Last Update Posted: June 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
  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: SPARC1102 I Drug: SPARC1102 II Drug: SPARC1102 III Drug: Vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


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: SPARC1102 I
1334H 0.15% eye drops will be administered in both eyes at 3 occasions
Drug: SPARC1102 I
SPARC1102 I will be administered in both eyes
Experimental: SPARC1102 II
1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
Drug: SPARC1102 II
SPARC1102 II will be administered in both eyes
Experimental: SPARC1102 III
1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
Drug: SPARC1102 III
SPARC1102 III will be administered in both eyes
Placebo Comparator: Vehicle
Placebo eye drops (solution)will be administered in both eyes at 3 occasions
Drug: Vehicle
Vehicle will be administered in both eyes

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320553


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

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01320553     History of Changes
Other Study ID Numbers: CLR_11_02
First Submitted: March 18, 2011
First Posted: March 22, 2011
Results First Submitted: March 10, 2016
Results First Posted: May 20, 2016
Last Update Posted: June 24, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases