NCT05665387

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

OPSIS: A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 47 Years – 55 Years
• Healthy volunteers: Not accepted

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

• Presbyopia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-22
• Primary completion: 2023-07-27
• Completion: 2023-07-27
• First posted: 2022-12-27
• Last updated: 2024-05-29
• Results posted: 2024-05-29

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study