Understanding Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
Southern College of Optometry
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.
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 becau…
Eligibility
- Age range
- 45–64 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 bet…
Interventions
- Drugpilocarpine HCL ophthalmic solution
Qlosi will be given to participants and quality of life will be determined.
Locations (2)
- Complete Eye Care of MedinaMedina, Minnesota
- The Southern College of OptometryMemphis, Tennessee