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

NCT05665387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2024-05-29

Study results available
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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.

Conditions

Interventions

DRUG

0.1% STN1013600 ophthalmic solution

0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months

DRUG

0.3% STN1013600 ophthalmic solution

0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months

DRUG

Placebo

Placebo ophthalmic solution 1 drop BID for 2 months

Sponsors & Collaborators

  • Santen Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
47 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2023-07-27
Completion
2023-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05665387 on ClinicalTrials.gov