CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
SJP-0132 +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.

Search/NCT04139122
NCT04139122Phase 2Completed

A Randomized, Double-Masked, Single-Center, Placebo-Controlled Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of SJP-0132 in Subjects With Dry Eye Disease

Senju Pharmaceutical Co., Ltd.·interventional·Posted Oct 25, 2019·Updated Apr 20, 2023

In Brief

A Phase 2 clinical trial evaluating SJP-0132 and Placebo for Dry Eye Disease and Dry Eye Syndrome. Completed, enrolled 89 participants across 1 site.

Detailed Summary

This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease

Study Details

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

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 25, 2019
Enrollment StartOct 5, 2019
Primary CompletionMar 3, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.7 years ago

Interventions

SJP-0132drug

SJP-0132 is administered as an eye drop

Placebodrug

Placebo is administered as an eye drop