search
Back to results

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
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 18, 2011
Last Updated
May 23, 2016
Sponsor
Sun Pharma Advanced Research Company Limited
search

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

Learn more about this trial

Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

We'll reach out to this number within 24 hrs