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0.1% STN1013600 ophthalmic solution for Presbyopia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Eye Research Foundation, Newport Beach, CAPresbyopia0.1% STN1013600 ophthalmic solution - Drug
Eligibility
47 - 55
All Sexes
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Lifitegrast 5% Ophthalmic Solution
1
STN1010904 ophthalmic suspension 0.1% BID
1
VVN539 Ophthalmic Solution 0.04%

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Month 2 and Month 3

Month 2
Subject treatment satisfaction as assessed by Patient Global Rating of Treatment
Month 3
Mean change from baseline in quality of life assessed with Near Activity Visual Questionnaire (NAVQ)
Month 3
Mean change from baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at all visits
Proportion of subjects who improve 1/2/3-lines or more in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA)
at Month 2
Mean change from baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Lifitegrast 5% Ophthalmic Solution
2
STN1010904 ophthalmic suspension 0.1% BID
2
VVN539 Ophthalmic Solution 0.04%

Trial Design

3 Treatment Groups

0.1% STN1013600 ophthalmic solution
1 of 3
0.3% STN1013600 ophthalmic solution
1 of 3
Placebo (Vehicle) ophthalmic solution
1 of 3

Experimental Treatment

Non-Treatment Group

75 Total Participants · 3 Treatment Groups

Primary Treatment: 0.1% STN1013600 ophthalmic solution · Has Placebo Group · Phase 2

0.1% STN1013600 ophthalmic solution
Drug
Experimental Group · 1 Intervention: 0.1% STN1013600 ophthalmic solution · Intervention Types: Drug
0.3% STN1013600 ophthalmic solution
Drug
Experimental Group · 1 Intervention: 0.3% STN1013600 ophthalmic solution · Intervention Types: Drug
Placebo (Vehicle) ophthalmic solution
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 2 and month 3

Who is running the clinical trial?

Santen Inc.Lead Sponsor
34 Previous Clinical Trials
4,557 Total Patients Enrolled

Eligibility Criteria

Age 47 - 55 · All Participants · 3 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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