Qlosi eye drops to improve daily life for people with presbyopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, phase 4 study in which participants will use Qlosi (pilocarpine HCl 0.4%) twice daily in both eyes. Distance-only spectacles will be provided at a dispense visit 1–2 weeks after screening to confirm distance visual acuity, then participants will start treatment and return after 4 weeks for outcome assessment. Quality-of-life and near-vision symptoms will be measured using validated instruments including the NAVQ-P and the VisQualT at baseline and week 4, with the week 4 visit occurring 4–6 hours after the participant's morning dose. Safety will be monitored with slit-lamp and ophthalmoscopy data collected at screening and other standard ocular exams.

Why it matters

Who can join: the full rules

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).

Where it's running

• Complete Eye Care of Medina
  Medina, Minnesota, United States Recruiting
• The Southern College of Optometry
  Memphis, Tennessee, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.