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Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
R89674 (generic name not yet established)
Sponsored by
Vistakon Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis focused on measuring Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: healthy normal volunteers age >=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better - Exclusion Criteria: 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 -

Sites / Locations

Outcomes

Primary Outcome Measures

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 Outcome Measures

No additional endpoints

Full Information

First Posted
September 20, 2005
Last Updated
February 19, 2015
Sponsor
Vistakon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00223951
Brief Title
Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers
Official Title
A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vistakon Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis
Keywords
Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
900 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
R89674 (generic name not yet established)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
No additional endpoints

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy normal volunteers age >=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better - Exclusion Criteria: 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack V Greiner, OD, DO, PhD
Organizational Affiliation
Ophthalmic Research Associates, North Andover, MA
Official's Role
Principal Investigator
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
City
North Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States

12. IPD Sharing Statement

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Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

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