Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

Recruiting now · Phase 4

Conditions studied: Presbyopia, Glasses, Dry Eye

In brief

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.

Key facts

Study ID

NCT07113210

Run by

Southern College of Optometry

People needed

36

Starts

2025-07-18

Expected to finish

2025-11-15

Last updated by the study team

2025-08-12

Who can join

Age: 45 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Complete Eye Care of Medina — Medina, Minnesota, United States (enrolling)
• The Southern College of Optometry — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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