Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

Southern College of Optometry

Status and phase

Enrolling

Phase 4

Conditions

Glasses

Dry Eye

Presbyopia

Treatments

Drug: pilocarpine HCL ophthalmic solution

Study type

Interventional

Funder types

Other

Identifiers

NCT07113210

qlosi00006733

Details and patient eligibility

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

45 to 64 years old

Volunteers

No Healthy Volunteers

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 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.

Exclusion criteria

Known hypersensitivity to any ingredient in the study drops.
Any active ocular condition that may confound study results (e.g., dry eye, allergy, conjunctivitis, ocular infection).
Any use of prescription eye drops 1 week before screening or during the study.
Any past use of the study drops.
Any contact lens use for the duration of the study.
Artificial tears or lubricant eye drops use on the day of or during any study visits.
Clinically significant abnormal findings (e.g., central corneal scar) on a slit lamp exam in either eye documented at screening or a known history of a clinically significant slit-lamp finding in either eye that could confound study results.
Have had an ocular surgical intervention within 6 months of the screening visit or planned surgical intervention during the study.
A female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy.
Any visible retinal findings noted upon a dilated fundus examination known to be a risk for use of study treatment (as determined by the investigator).