At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 637 enrolled
Drug / intervention
HL036 Ophthalmic Solution +1 morebiological
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, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HL036 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
In Brief
A Phase 3 clinical trial evaluating HL036 Ophthalmic Solution and Placebo for Dry Eye. Completed, enrolled 637 participants across 12 sites.
Detailed Summary
The objective of this study was to compare the safety and efficacy of 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesUnited States
CollaboratorsDaewoong Pharmaceutical Co. LTD.
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartMar 2019
Primary CompletionNov 2019
TodayJul 2026
First PostedFeb 19, 2019
Enrollment StartMar 10, 2019
Primary CompletionNov 22, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.4 years ago
Interventions
HL036 Ophthalmic Solutionbiological
HL036 Ophthalmic Solution
Placebobiological
Placebo vehicle solution