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CompletedNCT00364091Updated Sep 27, 2011

Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

A Phase 3 interventional study of R89674 0.025% ophthalmic solution in Allergic Conjunctivitis, sponsored by Vistakon Pharmaceuticals. Completed at 6 sites in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2011-09-27.

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

Phase
Phase 3
Study type
Interventional
Enrollment
365
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Study summary

The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

02

Conditions studied

  • Allergic Conjunctivitis

Keywords

  • allergic conjunctivitis, ophthalmology, multicenter, controlled
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 365 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Vistakon Pharmaceuticals is the lead sponsor of 12 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
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • history of positive diagnostic test for ragweed within the past 2 years;
  • positive bilateral response to ragweed as induced by conjunctival allergen challenge

Exclusion criteria

Exclusion Criteria:

  • ocular infection;
  • history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
  • moderate to severe asthma;
  • dry eye syndrome;
  • history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
  • pregnancy or lactation
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
365 participants (actual)

Interventions

  • DrugR89674 0.025% ophthalmic solution
06

What researchers measure

Primary outcomes

  1. Ocular itching and redness scores at defined timepoints

Secondary outcomes

  1. QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints

07

Study locations

6 sites
  • Louisville, Kentucky, United States
  • North Andover, Massachusetts, United States
  • Creve Coeur, Missouri, United States
  • Charlotte, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Memphis, Tennessee, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00364091
Lead sponsor
Vistakon Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 15, 2006
Start date
Aug 2006
Primary completion
Oct 2006
Last update
Sep 27, 2011

Study contacts

Reza Haque, MD
study director · Vistakon Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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