Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

NCT07113210 | Recruiting Phase 4 FDA Drug

• 1 other identifier: qlosi00006733
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Presbyopia; Glasses; Dry Eye

Outcome Measures

Primary Outcomes (1)

• Near Visual Acuity Questionnaire-Presbyopia

  • 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). In which higher scores are better.

  1 month

Secondary Outcomes (4)

• Visual Quality of Life with Time Survey (VisQualT)

  1 month

• Improvement in overall visual acuity score

  1 month

• Investigator developed survey

  1 month

• Text message surveys

  1 day, 1 week, 1 month

Study Arms (1)

Qlosi

EXPERIMENTAL

Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work

Drug: pilocarpine HCL ophthalmic solution

Interventions

pilocarpine HCL ophthalmic solution DRUG

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

Qlosi

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Southern College of Optometry: lead

Study Sites (2)

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

RECRUITING

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

RECRUITING

MeSH Terms

Conditions

Presbyopia; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participant's who qualify will be given Qlosi and instructions for how many drops to take.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: July 18, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 15, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (2)