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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: SPARC1102 I; Drug: SPARC1102 II; Drug: SPARC1102 III; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • ORA Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Itching	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.	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ciliary Redness Evaluated by the Investigator	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.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 18, 2011
• First Submitted That Met QC Criteria: March 19, 2011
• First Posted (Estimate): March 22, 2011

Study Record Updates

• Last Update Posted (Estimate): June 24, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: CLR_11_02