Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
Eligible age
45–64 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Southern College of Optometry
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.
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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07113210 · last updated 2025-08-12