PresbyopiaPhase 4NCT07113210
Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
A Phase 4 study testing pilocarpine HCL ophthalmic solution in people with Presbyopia and Glasses, run by Southern College of Optometry at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Presbyopia, Glasses, Dry Eye
- What is being tested?
- pilocarpine HCL ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2025to 15 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Complete Eye Care of Medina
Medina, Minnesota, 55340
Gina Wesley, OD, 763-478-3505, leahlang@cecofmedina.com
- Recruiting
The Southern College of Optometry
Memphis, Tennessee, 38104
Chris Lievens, OD, 9014815699, clievens@sco.edu
About this study
Official title: Understanding Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
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.
Read the detailed description
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.
- Conditions
- Presbyopia, Glasses, Dry Eye
- Being tested
- pilocarpine HCL ophthalmic solution
- Medical subject headings
- Presbyopia, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilocarpine HCL ophthalmic solutionDrug
Qlosi will be given to participants and quality of life will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Qlosi | Experimental | Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work Receives: Drug: pilocarpine HCL ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 day, 1 week, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start18 Jul 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participant's who qualify will be given Qlosi and instructions for how many drops to take.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113210
- Sponsor's protocol ID
- qlosi00006733
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
- ClinicalTrials.gov ID
- NCT07113210
- Acronym / sponsor ID
- qlosi00006733
- Conditions
- Presbyopia, Glasses, Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participant's who qualify will be given Qlosi and instructions for how many drops to take.
| Arm | Type | Receives |
|---|---|---|
| Qlosi | Experimental | Drug: pilocarpine HCL ophthalmic solutionSubjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pilocarpine HCL ophthalmic solutionQlosi will be given to participants and quality of life will be determined. | Drug | Qlosi |
Primary outcome
Near Visual Acuity Questionnaire-Presbyopia
Time frame: 1 month
• 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.
4 secondary outcomes
Visual Quality of Life with Time Survey (VisQualT)
Time frame: 1 month
Improvement in overall visual acuity score
Time frame: 1 month
Investigator developed survey
Time frame: 1 month
Text message surveys
Time frame: 1 day, 1 week, 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pilocarpine HCL ophthalmic solution in people with Presbyopia and Glasses, run by Southern College of Optometry at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near Visual Acuity Questionnaire-Presbyopia (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.