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Qlosi for Presbyopia and Quality of Life

This study is looking at how Qlosi™ (pilocarpine HCL ophthalmic solution) 0.4% eye drops affect the quality of life for people with presbyopia (age-related farsightedness). Researchers want to see if Qlosi™ improves symptoms like difficulty with near vision. You might be able to join if you are between 45 and 64 years old and have presbyopia. The study will measure improvements in your near vision and how your daily life is affected by your vision after using Qlosi™ for one month. The current recruitment status is unclear.

Study design
This is a multi-center study planning to enroll 36 participants. All participants will receive Qlosi™ eye drops.
What's involved
You would attend a screening visit, a spectacle dispense visit, and a final evaluation visit after 4 weeks of treatment. You would use Qlosi™ twice a day in both eyes.
Compensation
Participants will be compensated for their time.
Follow-up
You will be evaluated at 1 month after starting treatment.

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NCT07113210

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

Recruiting
PHASE4Ages 45–64InterventionalTreatment
Southern College of Optometry
~36 participants
Updated 2025-08-12 on ClinicalTrials.gov
What's tested:pilocarpine HCL ophthalmic solution

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Near Visual Acuity Questionnaire-Presbyopia
Measured over 1 month

Conditions

Presbyopia
Glasses
Dry Eye

Explore related trials

Presbyopia

Where it's being run

2 sites across 2 states
Minnesota1
Tennessee1

Who to contact

Gina Wesley, OD
[email protected]
763-478-3505
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Near Visual Acuity Questionnaire-Presbyopia1 month

    • 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). In which higher scores are better.