Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPARC1102 I
SPARC1102 II
SPARC1102 III
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility 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
Sites / Locations
- ORA Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SPARC1102 I
SPARC1102 II
SPARC1102 III
Vehicle
Arm Description
1334H 0.15% eye drops will be administered in both eyes at 3 occasions
1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
Placebo eye drops (solution)will be administered in both eyes at 3 occasions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01320553
First Posted
March 18, 2011
Last Updated
May 23, 2016
Sponsor
Sun Pharma Advanced Research Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT01320553
Brief Title
Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
Official Title
Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPARC1102 I
Arm Type
Experimental
Arm Description
1334H 0.15% eye drops will be administered in both eyes at 3 occasions
Arm Title
SPARC1102 II
Arm Type
Experimental
Arm Description
1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
Arm Title
SPARC1102 III
Arm Type
Experimental
Arm Description
1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo eye drops (solution)will be administered in both eyes at 3 occasions
Intervention Type
Drug
Intervention Name(s)
SPARC1102 I
Intervention Description
SPARC1102 I will be administered in both eyes
Intervention Type
Drug
Intervention Name(s)
SPARC1102 II
Intervention Description
SPARC1102 II will be administered in both eyes
Intervention Type
Drug
Intervention Name(s)
SPARC1102 III
Intervention Description
SPARC1102 III will be administered in both eyes
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle will be administered in both eyes
Primary Outcome Measure Information:
Title
Ocular Itching
Description
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.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Ciliary Redness Evaluated by the Investigator
Description
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.
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
ORA Inc
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
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Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
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