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Completed Phase 2 Interventional Results available

Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia

ClinicalTrials.gov ID: NCT05665387

Public ClinicalTrials.gov record NCT05665387. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 12, 2026, 10:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT05665387
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Santen Inc.
Industry
Enrollment
79 participants

Conditions and interventions

Eligibility (public fields only)

Age range
47 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 21, 2022
Primary completion
Jul 26, 2023
Completion
Jul 26, 2023
Last update posted
May 28, 2024

2022 – 2023

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Global Research Management Inc Glendale California 91204
Eye Research Foundation Newport Beach California 92663
Clayton Eye Clinical Research, LLC Morrow Georgia 30260
Comprehensive Eye Care, Ltd Washington Missouri 63090
Rochester Ophthalmological Group, P.C. Rochester New York 14618
Asheville Eye Associates Asheville North Carolina 28803
Scott Christie and Associates PC Cranberry Township Pennsylvania 16066
Vance Thompson Vision Clinic Sioux Falls South Dakota 57108
University Eye Specialists Maryville Tennessee 37803
Total Eye Care PA Memphis Tennessee 38119
The Cataract and Glaucoma Center El Paso Texas 79902
R and R Eye Research LLC San Antonio Texas 78229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05665387, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 28, 2024 · Synced Sep 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05665387 live on ClinicalTrials.gov.

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