A Phase 4 interventional study of pilocarpine HCL ophthalmic solution in Presbyopia, Glasses and Dry Eye, sponsored by Southern College of Optometry. Recruiting at 2 sites in United States. Open to participants aged 45 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Southern College of Optometry · Phase 4, Interventional, and Treatment
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
This will be a prospective, multi-center, study. Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work. All subjects will be prescribed a pair of distance spectacles (no near add) at the screening visit. The baseline survey and visual acuity data will be collected at the spectacle dispense visit (outcome measures). The screening visit data will be used as the baseline data for slit-lamp biomicroscope and indirect ophthalmoscopy and not repeated at the dispense visit. The investigators feel that this approach is reasonable because it is unlikely that the slit-lamp biomicroscope and indirect ophthalmoscopy data will change between the screening visit and dispense visit. Distance spectacles will be provided at a dispense visit 1-2 weeks after screening and a logMAR visual acuity of 0.00 or better OD/OS at distance will be confirmed. Subjects will then be instructed to start their treatment. After 4 weeks, subjects will return for an evaluation visit that will occur 4-6 hours after starting treatment for the day. Subjects will then be compensated for their time and exited from the study.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's planned enrollment of 36 is below the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Southern College of Optometry is the lead sponsor of 18 studies on the registry; 10 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work
Drug: pilocarpine HCL ophthalmic solution
Qlosi will be given to participants and quality of life will be determined.
Near Visual Acuity Questionnaire-Presbyopia
• 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). In which higher scores are better.
Time frame: 1 month
Visual Quality of Life with Time Survey (VisQualT)
• 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
Time frame: 1 month
Improvement in overall visual acuity score
• Improvement in presbyopic symptoms as measured with the overall quality of life VAS when using Qlosi™ at week 4 compared to baseline. In which higher scores are better
Time frame: 1 month
Investigator developed survey
• Improvement in presbyopic symptoms as measured with the Investigator-Developed Likert Survey when using Qlosi at week 4 compared to baseline. In which positive answers such as strongly agree are better.
Time frame: 1 month
Text message surveys
• Real-time text messaging to subjects on each day of treatment to identify time to treatment onset post-drop application (minutes). In which lower scores are better.
Time frame: 1 day, 1 week, 1 month
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Pilocarpine
Southern College of Optometry