Actively Recruiting

Phase 4
Age: 45Years - 64Years
All Genders
NCT07113210

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

Led by Southern College of Optometry · Updated on 2025-08-12

36

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

Who Can Participate

Age: 45Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects who are 45-64 years old (inclusive) at the time of screening.
  • Able and willing to provide written informed consent and sign a HIPAA form before any study procedures.
  • 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 between +0.75 D to +2.00 D in both eyes.
  • Spherical distance prescription between +1.00 D to -4.00 D in both eyes.
  • Cylinder power less than or equal to -1.00 D in both eyes.
  • Best-corrected distance visual acuity of 0.00 logMAR (20/20) or better in both eyes.
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to any ingredient in the study eye drops.
  • Any active eye condition that might affect study results, such as dry eye, allergy, conjunctivitis, or infection.
  • Use of prescription eye drops within 1 week before screening or during the study.
  • Any past use of the study eye drops.
  • Use of contact lenses during the study.
  • Use of artificial tears or lubricant eye drops on the day of or during any study visits.
  • Clinically significant abnormal findings on slit lamp exam that could affect results.
  • Eye surgery within 6 months before screening or planned during the study.
  • Female participants who are pregnant, nursing, or planning pregnancy.
  • Visible retinal findings on dilated exam that pose risk for study treatment as determined by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Complete Eye Care of Medina

Medina, Minnesota, United States, 55340

Actively Recruiting

2

The Southern College of Optometry

Memphis, Tennessee, United States, 38104

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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