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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 64
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Complete Eye Care of Medina
RECRUITING
Medina
Tennessee
The Southern College of Optometry
RECRUITING
Memphis
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2025-11-15
Participants
Target number of participants: 36
Treatments
Experimental: Qlosi
Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work
Related Therapeutic Areas
Sponsors
Leads: Southern College of Optometry

This content was sourced from clinicaltrials.gov