Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

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

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi (NCT07113210) is a Phase 4 interventional studying Presbyopia and Glasses, sponsored by Southern College of Optometry. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 36 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects who are 45-64 years old (inclusive) at the time of screening. - Be able and willing to provide written willing to sign a consent form 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. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DRUG

pilocarpine HCL ophthalmic solution

Qlosi will be given to participants and quality of life will be determined.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Complete Eye Care of Medina

Medina, Minnesota, United States

The Southern College of Optometry

Memphis, Tennessee, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07113210), the sponsor (Southern College of Optometry), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07113210 clinical trial studying?

Who can participate in NCT07113210?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07113210?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07113210. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07113210. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.