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

Completed · Phase 2 · Has a placebo group

Conditions studied: Presbyopia

In brief

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.

Key facts

Study ID

NCT05665387

Run by

Santen Inc.

People needed

79

Starts

2022-12-22

Expected to finish

2023-07-27

Last updated by the study team

2024-05-29

Who can join

Age: 47 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phakic presbyopic subjects, Male or Female between 47 and 55 years of age.
• Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, 70 EDTRS letters or worse (equivalent to 0.3 logMAR or worse; or 20/40 Snellen or worse) at 40 cm. To be reconfirmed at Visit 2 (Baseline).
• Best-corrected distance visual acuity (BCDVA) for each eye of 85 ETDRS letters or better (equivalent to 0.00 logMAR or better; or 20/20 Snellen or better) at 4 m. To be reconfirmed at Visit 2 (Baseline).

You may not qualify if…

• Secondary cause of presbyopia in either eye as assessed by investigator (e.g., damage to lens, zonules or ciliary muscle, multiple sclerosis, cardiovascular accidents, vascular insufficiency, myasthenia gravis, anemia, influenza, measles).
• Any history of ocular surgery (including ocular laser surgery) in either eye or plan of ocular surgery (including ocular laser surgery) during the course of the study.
• Prior invasive therapy for presbyopia (e.g., ciliary body electrostimulation, corneal implants).

Where it is running

• Global Research Management Inc — Glendale, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Clayton Eye Clinical Research, LLC — Morrow, Georgia, United States
• Comprehensive Eye Care, Ltd — Washington, Missouri, United States
• Rochester Ophthalmological Group, P.C. — Rochester, New York, United States
• Asheville Eye Associates — Asheville, North Carolina, United States
• Scott Christie and Associates PC — Cranberry Township, Pennsylvania, United States
• Vance Thompson Vision Clinic — Sioux Falls, South Dakota, United States
• University Eye Specialists — Maryville, Tennessee, United States
• Total Eye Care PA — Memphis, Tennessee, United States
• The Cataract and Glaucoma Center — El Paso, Texas, United States
• R and R Eye Research LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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