Effect of Different Concentrations of 1334H on Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320553
• Other study ID #: CLR_02_11
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2011
• Last updated: June 6, 2012
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Sun Pharma Advanced Research Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• 1334 H 0.15%
1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions
• 1334 H-0.3%
1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
• 1334 H-0.45%
1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
• Placebo
Placebo eye drops (solution)will be administered in both eyes at 3 occasions

Locations

Country	Name	City	State
United States	ORA Inc	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular itching and conjunctival redness at defined timepoints		Up to 4 weeks	No
Secondary	Ciliary and episcleral redness evaluated by the investigator		Up to 4 weeks	No