At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 534 enrolled
Drug / intervention
KetoNaph +1 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.
A Multi-center, Double-masked, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy, Normal Volunteers
In Brief
A Phase 3 clinical trial evaluating KetoNaph and Vehicle for Allergic Conjunctivitis. Completed, enrolled 534 participants.
Detailed Summary
This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Conjunctivitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedJul 2010
Primary CompletionSep 2010
Study CompletionOct 2010
TodayJul 2026
First PostedJul 9, 2010
Enrollment StartJul 1, 2010
Primary CompletionSep 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.0 years ago
Interventions
KetoNaphdrug
Ophthalmic Solution administered BID for 6 weeks
Vehicledrug
Vehicle of KetoNaph ophthalmic solution administered bid for six weeks