← Back to Search

0.1% STN1013600 ophthalmic solution for 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 and month 3

Awards & highlights

OPSIS Trial Summary

This trial will test if a new eye drop can reduce the need for reading glasses in people with presbyopia.

OPSIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 2 and month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 2 and month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 2 and month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change from baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)

Secondary outcome measures

Mean change from baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at all visits

Mean change from baseline in quality of life assessed with Near Activity Visual Questionnaire (NAVQ)

Proportion of subjects who improve 1/2/3-lines or more in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA)

+1 more

OPSIS 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Santen Inc.Lead Sponsor

34 Previous Clinical Trials

4,490 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to join this clinical research study?

"To become a part of this medical trial, volunteers must be between 47 and 55 years old with presbyopia. The team hopes to enlist up to 75 participants in total."

Answered by AI

Does this clinical trial permit elderly individuals over the age of 85 to participate?

"Participants for this medical study must be aged 47 and over, but below the age of 55."

Answered by AI

Are there any vacancies for prospective participants in this research?

"Per information on clinicaltrials.gov, this research is presently enrolling patients; it was initially publicized on December 21st 2022 and its particulars were most recently revised January 12th 2023."

Answered by AI

What is the aggregate participation in this clinical experiment?

"Affirmative. The clinicaltrials.gov website indicates that this trial is actively recruiting patients - it was initially posted on December 21st 2022 and has been modified most recently on January 12th 2023. 75 participants are needed for the study at two separate sites."

Answered by AI

What potential risks are associated with the application of 0.1% STN1013600 ophthalmic solution?

"Our assessment at Power rates 0.1% STN1013600 ophthalmic solution to be safe with a score of 2 since it is currently in Phase 2 trials; there are observations indicating its safety but no evidence showing efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05665387.

All > Montreal > Toronto