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CompletedNCT00223951Updated Feb 20, 2015

Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

A Phase 3 interventional study of R89674 (generic name not yet established) in Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis, sponsored by Vistakon Pharmaceuticals. Completed at 6 sites in United States. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-20.

Sponsored by Vistakon Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
3 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

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

Keywords

  • Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic
03

In context

Conjunctivitis, Allergic

231 studies on the registry are indexed under Conjunctivitis, Allergic; 19 are open to participants now.

This study's enrollment of 900 is above the median of 85 across 192 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

Vistakon Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
900 participants
06

What researchers measure

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

07

Study locations

6 sites
  • Phoenix, Arizona 85032, United States
  • Bel Air, Maryland 21014, United States
  • North Andover, Massachusetts 01845, United States
  • Las Vegas, Nevada 89102, United States
  • Charlotte, North Carolina 28204, United States
  • Philadelphia, Pennsylvania 19148, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2005 and a primary completion of Dec 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2005
First posted
Sep 22, 2005
Start
Sep 2005
Primary completionActual
Dec 2005
Last update
Feb 20, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00223951
Lead sponsor
Vistakon Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Sep 2005
Primary completion
Dec 2005
Last update
Feb 20, 2015

Study contacts

Jack V Greiner, OD, DO, PhD
principal investigator · Ophthalmic Research Associates, North Andover, MA
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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