NCT07113210

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Southern College of Optometry · Academic / Other
• Sex: All
• Age: 45 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a prospective, multi-center, study. Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work. All subjects will be prescribed a pair of distance spectacles (no near add) at the screening visit. The baseline survey and visual acuity data will be collected at the spectacle dispense visit (outcome measures). The screening visit data will be used as the baseline data for slit-lamp biomicroscope and indirect ophthalmoscopy and not repeated at the dispense visit. The investigators feel that this approach is reasonable because it is unlikely that the slit-lamp biomicroscope and indirect ophthalmoscopy data will change between the screening visit and dispense visit. Distance spectacles will be provided at a dispense visit 1-2 weeks after screening and a logMAR visual acuity of 0.00 or better OD/OS at distance will be confirmed. Subjects will then be instructed to start their treatment. After 4 weeks, subjects will return for an evaluation visit that will occur 4-6 hours after starting treatment for the day. Subjects will then be compensated for their time and exited from the study.

Conditions

• Presbyopia
• Glasses
• Dry Eye

Interventions

Type	Name	Description
DRUG	pilocarpine HCL ophthalmic solution	Qlosi will be given to participants and quality of life will be determined.

Timeline

• Start date: 2025-07-18
• Primary completion: 2025-10-31
• Completion: 2025-11-15
• First posted: 2025-08-08
• Last updated: 2025-08-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study