Qlosi eye drops to improve daily life for people with presbyopia
Understanding Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
This trial will test whether Qlosi 0.4% eye drops, used twice daily, can improve quality of life for people aged 45–64 who have presbyopia and need near vision help.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 45 Years to 64 Years |
| Sex | All |
| Sponsor | Southern College of Optometry Academic / other |
| Locations | 2 sites (Medina, Minnesota and 1 other locations) |
| Trial ID | NCT07113210 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, phase 4 study in which participants will use Qlosi (pilocarpine HCl 0.4%) twice daily in both eyes. Distance-only spectacles will be provided at a dispense visit 1–2 weeks after screening to confirm distance visual acuity, then participants will start treatment and return after 4 weeks for outcome assessment. Quality-of-life and near-vision symptoms will be measured using validated instruments including the NAVQ-P and the VisQualT at baseline and week 4, with the week 4 visit occurring 4–6 hours after the participant's morning dose. Safety will be monitored with slit-lamp and ophthalmoscopy data collected at screening and other standard ocular exams.
Who should consider this trial
Good fit: Ideal candidates are adults 45–64 years old with symptomatic presbyopia, a study-confirmed near add of +0.75 to +2.00 D, spherical distance prescription between +1.00 and -4.00 D, cylinder ≤1.00 D, and best-corrected distance acuity of 0.00 logMAR (20/20) or better in each eye.
Not a fit: Patients with active ocular conditions that could confound results (such as significant dry eye, allergy, conjunctivitis), known hypersensitivity to study drug ingredients, or refractive/add ranges outside the eligibility criteria are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, Qlosi could reduce near-vision blur and improve the ability to perform reading and other close-up tasks without relying on near-add glasses.
How similar studies have performed: Other pilocarpine-based eye drops have improved near vision in presbyopia in prior studies, and this phase 4 effort focuses on measuring real-world quality-of-life effects with Qlosi.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Medina, Minnesota and 1 other locations
- Complete Eye Care of Medina — Medina, Minnesota, United States (Recruiting)
- The Southern College of Optometry — Memphis, Tennessee, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.