RecruitingPhase 4NCT07113210

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

Understanding Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

Sponsor

Southern College of Optometry

Enrollment

36 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Dry Eye Presbyopia Glasses

Summary

The goal of this clinical trial is to determine how Qlosi™ (pilocarpine HCL ophthalmic solution) 0.4%impacts the quality of life of participants with presbyopia by using a battery of validated and investigator-developed instruments * Improvement in presbyopic symptoms as measured with the Near Activity Visual Questionnaire-Presbyopia (NAVQ-P) when using Qlosi™ at week 4 compared to baseline (continuous variable). * Improvement in presbyopic symptoms as measured with the Visual Quality of Life with Time Survey (VisQualT) questionnaire when using Qlosi™ at week 4 compared to baseline.

Eligibility

Min Age: 45 YearsMax Age: 64 Years

Inclusion Criteria9

Subjects who are 45-64 years old (inclusive) at the time of screening.
Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed.
Be able and willing to follow all instructions and attend study visits.
Have text messaging capabilities on their phone.
Self-reported complaints of near vision blur when fully corrected at distance.
Study confirmed near add that is between +0.75 D to +2.00 D OD/OS (inclusive).
Spherical distance prescription between +1.00 D to -4.00 D OD/OS (inclusive).
Cylinder power less than or equal to -1.00 D OD/OS.
Best-corrected visual acuity (BCVA) at distance of 0.00 logMAR (20/20 Snellen equivalent) or better OD/OS.

Exclusion Criteria10

Known hypersensitivity to any ingredient in the study drops.
Any active ocular condition that may confound study results (e.g., dry eye, allergy, conjunctivitis, ocular infection).
Any use of prescription eye drops 1 week before screening or during the study.
Any past use of the study drops.
Any contact lens use for the duration of the study.
Artificial tears or lubricant eye drops use on the day of or during any study visits.
Clinically significant abnormal findings (e.g., central corneal scar) on a slit lamp exam in either eye documented at screening or a known history of a clinically significant slit-lamp finding in either eye that could confound study results.
Have had an ocular surgical intervention within 6 months of the screening visit or planned surgical intervention during the study.
A female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy.
Any visible retinal findings noted upon a dilated fundus examination known to be a risk for use of study treatment (as determined by the investigator).