Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Louisville, Kentucky, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

R89674 0.025% ophthalmic solution

Drug

Primary outcomes

Ocular itching and redness scores at defined timepoints

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Vistakon Pharmaceuticals

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis

Important dates

Study start: 2006
Primary completion: 2006
First posted: Aug 15, 2006
Registry last updated: Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed