NCT00223951

Brief Summary

The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers

Trial Health

80
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

6 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

September 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

September 20, 2005

Last Update Submit

February 19, 2015

Conditions

Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis

Keywords

Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic

Outcome Measures

Primary Outcomes (1)

  • Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination

Secondary Outcomes (1)

  • No additional endpoints

Interventions

R89674 (generic name not yet established)DRUG

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy normal volunteers age \>=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better

You may not qualify if:

  • intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female \< 18 years of age -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Phoenix, Arizona, 85032, United States

Location

Unknown Facility

Bel Air, Maryland, 21014, United States

Location

Unknown Facility

North Andover, Massachusetts, 01845, United States

Location

Unknown Facility

Las Vegas, Nevada, 89102, United States

Location

Unknown Facility

Charlotte, North Carolina, 28204, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jack V Greiner, OD, DO, PhD

    Ophthalmic Research Associates, North Andover, MA

    PRINCIPAL INVESTIGATOR

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

September 20, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2005

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

US(6)