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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 (OPSIS Trial)

Phase 2
Waitlist Available
Research Sponsored by Santen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 2

Summary

This trial tests eye drops called STN1013600 in people with presbyopia to see if it helps them focus better on nearby objects. The study compares two strengths of the drops over several weeks.

Eligible Conditions
  • Presbyopia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
Secondary study objectives
Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2
Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 0.3% STN1013600 ophthalmic solutionExperimental Treatment1 Intervention
0.3% STN1013600 ophthalmic solution 1 drop BID
Group II: 0.1% STN1013600 ophthalmic solutionExperimental Treatment1 Intervention
0.1% STN1013600 ophthalmic solution 1 drop BID
Group III: Placebo (Vehicle) ophthalmic solutionPlacebo Group1 Intervention
Placebo (Vehicle) ophthalmic solution BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.1% STN1013600 ophthalmic solution
2022
Completed Phase 2
~80
0.3% STN1013600 ophthalmic solution
2022
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Santen Inc.Lead Sponsor
34 Previous Clinical Trials
4,490 Total Patients Enrolled
~26 spots leftby Dec 2025
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