At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,936 enrolled
Drug / intervention
Sodium Hyaluronate Ophthalmic Solution, 0.18% +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 Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome
In Brief
A Phase 3 clinical trial evaluating Sodium Hyaluronate Ophthalmic Solution, 0.18% and Vehicle for Dry Eye Syndrome. Completed, enrolled 1,936 participants.
Detailed Summary
The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartJul 2011
Primary CompletionMay 2012
TodayJul 2026
First PostedJun 27, 2011
Enrollment StartJul 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.0 years ago
Interventions
Sodium Hyaluronate Ophthalmic Solution, 0.18%drug
Vehicleother
Inactive ingredients used as run-in and placebo comparator