Effect of Different Concentrations of 1334H on Allergic Conjunctivitis
This study has been completed.
Sponsor:
Sun Pharma Advanced Research Company Limited
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
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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
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, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013