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Actively Recruiting

Phase 4
Age: 45Years - 64Years
All Genders
ID07113210

Study of Qlosi Eye Drops to Improve Quality of Life in People Aged 45 to 64 With Presbyopia

Led by Southern College of Optometry · Updated on 2025-08-12

36

Participants Needed

2

Research Sites

2 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how Qlosi14 pilocarpine HCL ophthalmic solution 0.4% affects the quality of life in people with presbyopia, a condition causing near vision problems. This Phase 4, multi-center study aims to measure improvements in near vision symptoms using validated questionnaires such as the Near Activity Visual Questionnaire-Presbyopia NAVQ-P and the Visual Quality of Life with Time Survey VisQualT. The study focuses on participants aged 45 to 64 who experience near vision blur despite having corrected distance vision. Participants will use Qlosi twice daily in both eyes, while only using reading glasses for urgent tasks. At the screening visit, all subjects will receive distance spectacles without near correction and have their baseline visual acuity and survey data collected. After confirming good distance vision with the spectacles, participants will start the study treatment. The treatment period lasts four weeks, after which participants return for an evaluation visit to assess changes in vision and quality of life. During the study, researchers will collect visual acuity data, responses to questionnaires, and text message surveys at various time points up to one month. Eye exams including slit-lamp biomicroscopy and indirect ophthalmoscopy will be performed at screening. Participants will be monitored for any changes or side effects, and after completing the evaluation visit, they will be compensated and exited from the study. The total participation time spans approximately 4 to 6 weeks from screening to study exit.

CONDITIONS

Brief Title

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

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