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Recruiting NCT05665387

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

Conditions: Presbyopia

Sex: All
Ages: 47 Years – 55 Years
Phase: PHASE2
Enrollment: 75
Sponsor: Santen Inc.

Location: United States

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.

Eligibility Criteria

Inclusion Criteria: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).Exclusion Criteria: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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05665387). StuddyBuddy aggregates publicly available trial information.