Recruiting

Qlosi™

Sponsor:

Southern College of Optometry

Code:

NCT07113210

Conditions

Presbyopia

Glasses

Dry Eye

Eligibility Criteria

Sex: All

Age: 45 - 64

Healthy Volunteers: Not accepted

Interventions

pilocarpine HCL ophthalmic solution

Study Details

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

Study ID

NCT07113210

Start date

Jul 18, 2025

Status verified date

Aug, 2025

Completion date

Nov 15, 2025

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 64

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Qlosi

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

Interventions

pilocarpine HCL ophthalmic solution

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

Primary outcome measure

  • Near Visual Acuity Questionnaire-Presbyopia [ Time Frame: 1 month ]

Central Contacts and Locations

Locations

Complete Eye Care of Medina

Recruiting

Medina, Minnesota, United States, 55340

Contacts

Gina Wesley, OD

763-478-3505leahlang@cecofmedina.com

The Southern College of Optometry

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Chris Lievens, OD

9014815699clievens@sco.edu

More Information

Sponsor

Southern College of Optometry

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southern College of Optometry on 2025-08-12.