Phase 2
N=79
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT05665387 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) — 4.1; 4.3; 4.4 EDTRS letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.1% STN1013600 ophthalmic solution (Drug); 0.3% STN1013600 ophthalmic solution (Drug); Placebo (Drug)
- Age
- Adult · 47+ yrs
- Sex
- All
- Sponsor
- Santen Inc.
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) |
4.1; 4.3; 4.4 | — |
| SECONDARY Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 |
62.2; 63.5; 63.8; 66.4; 67.9; 68.7 | — |
| SECONDARY 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 |
13; 17; 5; 6; 12; 0 | — |
| SECONDARY Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2 |
-7.493; -8.140; -10.510 | — |
| SECONDARY Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment |
13; 18; 9 | — |
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).
Data sourced from ClinicalTrials.gov (NCT05665387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.