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NCT05665387 · ClinicalTrials.gov registry record · Phase 2
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
A Phase 2 study, sponsored by Santen.
- Completed
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
NCT05665387: Completed Phase 2 study, sponsored by Santen.
NCT05665387 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 79 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05665387, a Phase 2 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
Study 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.
Primary Outcome
Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.
Interventions
- DRUG Placebo
- DRUG 0.1% STN1013600 ophthalmic solution
- DRUG 0.3% STN1013600 ophthalmic solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2022-12-22 |
| Est. Completion | 2023-07-27 |
| Phase | Phase 2 |
What the finished NCT05665387 record still lists
NCT05665387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05665387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05665387 about?
NCT05665387 is a clinical study titled "Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia". 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 Tr...
What is the current status of trial NCT05665387?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2022-12-22. Estimated completion is 2023-07-27.
What interventions are being tested in trial NCT05665387?
The interventions under investigation include: Placebo (DRUG), 0.1% STN1013600 ophthalmic solution (DRUG), 0.3% STN1013600 ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT05665387?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05665387's enrollment target sits among peer trials
79 884th of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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