---
title: Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers
nct_id: NCT00223951
overall_status: COMPLETED
phase: PHASE3
sponsor: Vistakon Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00223951.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00223951"
ct_last_update_post_date: 2015-02-20
last_seen_at: "2026-05-12T06:23:53.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT00223951](https://clinicaltrials.gov/study/NCT00223951)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 900
- **Lead Sponsor:** Vistakon Pharmaceuticals
- **Conditions:** Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis
- **Start Date:** 2005-09
- **CT.gov Last Update:** 2015-02-20

## Brief Summary

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

## Eligibility

- **Minimum age:** 3 Years
- **Sex:** ALL
- **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 -
```

## Interventions

- **R89674 (generic name not yet established)** (DRUG)

## Primary Outcomes

- **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

- **No additional endpoints**

## Locations (6)

- Phoenix, Arizona, United States
- Bel Air, Maryland, United States
- North Andover, Massachusetts, United States
- Las Vegas, Nevada, United States
- Charlotte, North Carolina, United States
- Philadelphia, Pennsylvania, United States

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|phoenix|arizona|united states` — added _(2026-05-12)_
- `locations.|bel air|maryland|united states` — added _(2026-05-12)_
- `locations.|north andover|massachusetts|united states` — added _(2026-05-12)_
- `locations.|las vegas|nevada|united states` — added _(2026-05-12)_
- `locations.|charlotte|north carolina|united states` — added _(2026-05-12)_
- `locations.|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00223951.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00223951*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*