NCT00241319

Brief Summary

The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

5 active sites

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

Study Start

First participant enrolled

October 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

2 months

First QC Date

October 14, 2005

Last Update Submit

September 26, 2011

Conditions

Allergic Conjunctivitis

Keywords

ocular, allergic conjunctivitis, ophthalmic

Outcome Measures

Primary Outcomes (1)

  • Ocular itching and conjunctival redness post challenge

Secondary Outcomes (1)

  • Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge

Interventions

R89674 (generic name not yet established)DRUG

Eligibility Criteria

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

You may qualify if:

  • history of ocular allergies and a positive skin test reaction to cat hair,
  • cat dander, grasses, ragweed, and/or trees within the past 24 months;
  • calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction

You may not qualify if:

  • narrow angle glaucoma,
  • clinically significant blepharitis, follicular conjunctivitis, iritis
  • pterygium or diagnosis of dry eye
  • ocular surgical intervention within 3 months
  • history of refractive surgery within 6 months
  • known history of retinal detachment, diabetic retinopathy, or progressive retinal disease
  • presence of active ocular infection positive history of an ocular herpetic infection
  • preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Lewiston, Maine, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ingerman Avner, MD

    Johnson & Johnson

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2005

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

US(5)