CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 144 enrolled
Drug / intervention
Ketotifen/naphazoline +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00769886
NCT00769886Phase 3Completed
CompareCT.gov

A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis

Bausch & Lomb Incorporated·interventional·Posted Oct 9, 2008·Updated Apr 3, 2024

In Brief

A Phase 3 clinical trial evaluating Ketotifen/naphazoline, Ketotifen, and 2 other interventions for Allergic Conjunctivitis. Completed, enrolled 144 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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Conjunctivitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 9, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2008
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.7 years ago

Interventions

Ketotifen/naphazolinedrug

One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.

Ketotifendrug

One drop of Ketotifen in study eye at visit 3 and visit 4.

Naphazolinedrug

One drop of naphazoline in study eye at vist 3 and visit 4.

Vehicledrug

One drop of vehicle in study eye at visit 3 and visit 4.