Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants Wit… (NCT06542497) | Clinical Trial Compass
CompletedPhase 3
Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia
United States569 participantsStarted 2024-08-15
Plain-language summary
Safety and efficacy of POS in participants with presbyopia
Who can participate
Age range45 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males or females ≥ 45 and ≤ 64 years of age
✓. Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
✓. Able and willing to give signed informed consent
✓. Able to self-administer study medication throughout the study period
✓. BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20 Snellen equivalent) or better in photopic conditions in each eye
✓. DCNVA of 50 ETDRS letters (20/50 Snellen equivalent) or worse but not \<35 ETDRS letters (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly
✓. For participants who depend on reading glasses or bifocals, binocular best-corrected near VA of 65 ETDRS letters (20/25 Snellen equivalent) or better
✓. Photopic PD of ≥ 4 mm in the study eye at Screening
Exclusion criteria
✕. Use of any topical prescription (including Vuity® or Qlosi™) or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.) and artificial tears as specified in Exclusion Criterion #2 below
✕. Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication
✕. Use of Ryzumvi™ (POS) within 7 days prior to Screening
✕. Use of any dry eye product, such as topical ophthalmic therapy for dry eye (eg, generic cyclosporine, Restasis®, Xiidra®, Cequa®, Eysuvis®, and Meibo®) or intranasal dry eye product (eg, Tyrvaya®) or other devices within 12 months prior to Screening
✕. Tear break-up time of \< 5 seconds or corneal fluorescein staining (CFS) Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale
✕. Clinically significant ocular disease (eg, cataract, glaucoma, corneal edema, uveitis, retinal degeneration, loss of visual field, or any macular pathology) that, in the judgment of the Investigator, might interfere with study procedures
✕. Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, keratitis, etc.). Participants must be symptom free for at least 7 days prior to Screening
✕. Any history of herpes simplex or herpes zoster keratitis