At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 69 enrolled
Drug / intervention
TOP1630 Ophthalmic Solution +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 Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome
In Brief
A Phase 2 clinical trial evaluating TOP1630 Ophthalmic Solution and Placebo to TOP1630 Ophthalmic Solution for Dry Eye Syndrome. Completed, enrolled 69 participants across 1 site.
Detailed Summary
In subjects with Dry Eye Syndrome: The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo. The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesUnited States
CollaboratorsTopivert Pharma Ltd
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartFeb 2017
First PostedMar 2017
Primary CompletionJun 2017
TodayJul 2026
First PostedMar 23, 2017
Enrollment StartFeb 20, 2017
Primary CompletionJun 15, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.3 years ago
Interventions
TOP1630 Ophthalmic Solutiondrug
Bilateral ocular drug administration
Placebo to TOP1630 Ophthalmic Solutiondrug
Bilateral ocular drug administration