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

Santen

Status and phase: Completed; Phase 2

Conditions: Presbyopia

Treatments: Drug: 0.3% STN1013600 ophthalmic solution; Drug: 0.1% STN1013600 ophthalmic solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05665387

101360002IN

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 47 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 3 patient groups, including a placebo group

0.1% STN1013600 ophthalmic solution

Experimental group

Description:

0.1% STN1013600 ophthalmic solution 1 drop BID

Treatment:

Drug: 0.1% STN1013600 ophthalmic solution

0.3% STN1013600 ophthalmic solution

Experimental group

Description:

0.3% STN1013600 ophthalmic solution 1 drop BID

Treatment:

Drug: 0.3% STN1013600 ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Placebo Comparator group

Description:

Placebo (Vehicle) ophthalmic solution BID

Treatment:

Drug: Placebo