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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qlosi | Experimental | Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pilocarpine HCL ophthalmic solution | Drug | Qlosi will be given to participants and quality of life will be determined. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Improvement in overall visual acuity score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complete Eye Care of Medina | Recruiting | Medina | Minnesota | 55340 | United States |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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Participant's who qualify will be given Qlosi and instructions for how many drops to take.
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• 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 |
| 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. | 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. | 1 day, 1 week, 1 month |
| The Southern College of Optometry | Recruiting | Memphis | Tennessee | 38104 | United States |
|