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New treatment option for Presbyopia
Official title Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
ClinicalTrials.gov ID: NCT07113210
What this study is testing
What is pilocarpine HCL ophthalmic solution?
pilocarpine HCL ophthalmic solution is an investigational medicine, being studied as a potential treatment for presbyopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 64
You may be able to join if
- people 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...
- 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.
You likely can't join 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.
See the full eligibility criteria
- people 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.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Medina, Minnesota, United States
- Memphis, Tennessee, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Medina, Minnesota, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.