CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
0.1% STN1013600 ophthalmic solution +2 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/NCT05665387
NCT05665387Phase 2Completed
CompareCT.gov

OPSIS: A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia

Santen Inc.·interventional·Posted Dec 27, 2022·Updated May 29, 2024

In Brief

A Phase 2 clinical trial evaluating 0.1% STN1013600 ophthalmic solution, 0.3% STN1013600 ophthalmic solution, and 1 other intervention for Presbyopia. Completed, enrolled 79 participants across 12 sites.

Detailed Summary

This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to Placebo in subjects diagnosed with presbyopia. This study will consist of a Screening Period of up to 15 days followed by a 2 Month Treatment Period. After the Treatment Period subjects will be followed for a one-month treatment free period.

Study Details

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

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedDec 27, 2022
Enrollment StartDec 22, 2022
Primary CompletionJul 27, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.5 years ago

Interventions

0.1% STN1013600 ophthalmic solutiondrug

0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months

0.3% STN1013600 ophthalmic solutiondrug

0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months

Placebodrug

Placebo ophthalmic solution 1 drop BID for 2 months