NCT07113210 Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
| NCT ID | NCT07113210 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Southern College of Optometry |
| Condition | Presbyopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-07-18 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 36 participants in total. It began in 2025-07-18 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Frequently Asked Questions
Who can join the NCT07113210 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 64 Years, studying Presbyopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07113210 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07113210 currently recruiting?
Yes, NCT07113210 is actively recruiting participants. Visit ClinicalTrials.gov or contact Southern College of Optometry to inquire about joining.
Where is the NCT07113210 trial being conducted?
This trial is being conducted at Medina, United States, Memphis, United States.
Who is sponsoring the NCT07113210 clinical trial?
NCT07113210 is sponsored by Southern College of Optometry. The trial plans to enroll 36 participants.