NCT01320553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

May 20, 2016

Completed
Last Updated

June 24, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

March 18, 2011

Results QC Date

March 10, 2016

Last Update Submit

May 23, 2016

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ciliary Redness Evaluated by the Investigator

    Up to 4 weeks

Study Arms (4)

SPARC1102 I

EXPERIMENTAL

1334H 0.15% eye drops will be administered in both eyes at 3 occasions

Drug: SPARC1102 I

SPARC1102 II

EXPERIMENTAL

1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions

Drug: SPARC1102 II

SPARC1102 III

EXPERIMENTAL

1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions

Drug: SPARC1102 III

Vehicle

PLACEBO COMPARATOR

Placebo eye drops (solution)will be administered in both eyes at 3 occasions

Drug: Vehicle

Interventions

SPARC1102 IDRUG

SPARC1102 I will be administered in both eyes

SPARC1102 I
SPARC1102 IIDRUG

SPARC1102 II will be administered in both eyes

SPARC1102 II
SPARC1102 IIIDRUG

SPARC1102 III will be administered in both eyes

SPARC1102 III
VehicleDRUG

Vehicle will be administered in both eyes

Vehicle

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ORA Inc

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

Of the total of 122 subjects, 8 subjects did not complete the study: 114 subjects completed the study, PP population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects.

Results Point of Contact

Title
Shravanti Bhowmik, MD
Organization
SPARC
shravanti.bhowmik@sparcmail.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 22, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

June 24, 2016

Results First Posted

May 20, 2016

Record last verified: 2016-05

Locations

US(1)