At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.
In Brief
A Phase 3 clinical trial evaluating Ketotifen/naphazoline, Naphazoline, and 2 other interventions for Allergic Conjunctivitis. Completed, enrolled 141 participants across 1 site.
Detailed Summary
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
Study Details
Timeline
Interventions
One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
One drop of vehicle ophthalmic solution at visit 3 and visit 4.