💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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).
💊
What it tests
- pilocarpine HCL ophthalmic solution
Complete Eye Care of Medina
Medina, United States
The Southern College of Optometry
Memphis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.