Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223951

Enrollment

900

Registered

2005-09-22

Start date

2005-09-30

Completion date

Unknown

Last updated

2015-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic

Brief summary

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

Interventions

DRUGR89674 (generic name not yet established)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
No additional endpoints	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026