Actively Recruiting
Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
Led by Southern College of Optometry · Updated on 2025-08-12
36
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who are 45-64 years old (inclusive) at the time of screening.
- Able and willing to provide written informed consent and sign a HIPAA form before any study procedures.
- 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 between +0.75 D to +2.00 D in both eyes.
- Spherical distance prescription between +1.00 D to -4.00 D in both eyes.
- Cylinder power less than or equal to -1.00 D in both eyes.
- Best-corrected distance visual acuity of 0.00 logMAR (20/20) or better in both eyes.
You will not qualify if you...
- Known hypersensitivity to any ingredient in the study eye drops.
- Any active eye condition that might affect study results, such as dry eye, allergy, conjunctivitis, or infection.
- Use of prescription eye drops within 1 week before screening or during the study.
- Any past use of the study eye drops.
- Use of contact lenses during the study.
- Use of artificial tears or lubricant eye drops on the day of or during any study visits.
- Clinically significant abnormal findings on slit lamp exam that could affect results.
- Eye surgery within 6 months before screening or planned during the study.
- Female participants who are pregnant, nursing, or planning pregnancy.
- Visible retinal findings on dilated exam that pose risk for study treatment as determined by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Complete Eye Care of Medina
Medina, Minnesota, United States, 55340
Actively Recruiting
2
The Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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