Clinical trial NCT05665387: Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Keywords: Santen, Presbyopia, Eye
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 79
Sex: ALL
Minimum age (years): 47
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Primary outcomes:
measure: Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: At Month 2
Secondary outcomes:
measure: Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2
timeFrame: Month 2
measure: Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2
timeFrame: Month 2
measure: Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2
timeFrame: Month 2
measure: Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment
timeFrame: Month 2
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Global Research Management Inc
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd
state: Missouri
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, P.C.
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott Christie and Associates PC
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision Clinic
state: South Dakota
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
city: El Paso
country: United States
facility: The Cataract and Glaucoma Center
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research LLC
state: Texas
Study officials:
References: