RECRUITING

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-18

Study Completion:2025-11-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07113210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Study Locations (Sites)

Complete Eye Care of Medina

Medina, Minnesota, 55340

United States

The Southern College of Optometry

Memphis, Tennessee, 38104

United States

Collaborators and Investigators

Sponsor: Southern College of Optometry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-18

Study Completion Date2025-11-15

Study Record Updates

Study Start Date2025-07-18

Study Completion Date2025-11-15

Terms related to this study

Additional Relevant MeSH Terms

Presbyopia
Glasses
Dry Eye