Qlosi for Presbyopia

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Southern College of Optometry

Must not be taking: Prescription eye drops

Disqualifiers: Ocular conditions, Pregnancy, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new eye drop, Qlosi™, can enhance the quality of life for individuals with presbyopia, which causes blurry near vision. Researchers aim to determine if Qlosi™ aids in everyday tasks, such as reading, and eases life for those with this condition. Participants should experience difficulty seeing up close, even if their distance vision is corrected. As a Phase 4 trial, Qlosi™ is already FDA-approved and proven effective, and this research seeks to understand how it benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial requires that you stop using any prescription eye drops one week before screening and during the study. Other medications are not mentioned, so it's best to discuss with the study team.

What is the safety track record for this treatment?

Research has shown that Qlosi, an eye drop solution, is generally safe and well-tolerated. It has been tested in five clinical trials with many participants. In two key studies, 309 people with presbyopia (difficulty seeing things up close) used Qlosi for 15 days. The results indicated that most participants tolerated Qlosi well.

However, some side effects were observed. These may include temporary dim or dark vision, so caution is advised when driving at night or engaging in activities in low light. It is also recommended to remove contact lenses before using Qlosi and wait 10 minutes before reinserting them. Overall, the safety data from these studies supports using Qlosi, but following the usage guidelines is important to reduce any risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Qlosi is unique because it offers a new approach to treating presbyopia, which traditionally relies on reading glasses or contact lenses. Unlike these standard options, Qlosi is administered as an eye drop, allowing for a non-invasive, convenient solution that can be used on-the-go. Researchers are excited because this treatment has the potential to improve near vision without the immediate need for corrective lenses, providing a more seamless vision correction experience.

What is the effectiveness track record for Qlosi in treating presbyopia?

Research has shown that Qlosi™ (a pilocarpine eye drop) 0.4% effectively treats presbyopia, a condition where close-up vision becomes difficult with age. Studies found that 84.2% of individuals with early presbyopia achieved clear near vision (20/40 or better) on the first day of using Qlosi, when applied up to twice daily. Another study demonstrated that Qlosi significantly improved near vision compared to a placebo. These findings suggest that Qlosi can enhance near vision for those with presbyopia. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with presbyopia, a condition that affects near vision typically in middle-aged and older adults. Participants should also have dry eye syndrome. They must not currently be using any other treatments for these conditions.

Inclusion Criteria

Spherical distance prescription between +1.00 D to -4.00 D OD/OS (inclusive)

My eye prescription for astigmatism is -1.00 D or less in both eyes.

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

I have not used prescription eye drops in the week before screening or during the study.

I have not had eye surgery in the last 6 months and don't plan to during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive Qlosi™ BID OD/OS and are monitored for improvement in presbyopic symptoms

4 weeks

Daily treatment with evaluation at 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Qlosi

Trial Overview

The study tests Qlosi™ (pilocarpine HCL ophthalmic solution) to see if it improves the quality of life and symptoms of presbyopia. The effects are measured at week 4 compared to when they started, using specific questionnaires designed to assess visual function.

How Is the Trial Designed?

Group I: Qlosi Experimental Treatment 1 Intervention

Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work

Who Is Running the Clinical Trial?

Southern College of Optometry

Lead Sponsor

Trials

8

Recruited

390+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07113210

Quality of Life in Presbyopic Patients Who Are Treated With ...

Improvement in presbyopic symptoms as measured with the Near Activity Visual Questionnaire-Presbyopia (NAVQ-P) when using Qlosi at week 4 ...

2.

qlosiecp.com

qlosiecp.com/efficacy

Efficacy | Qlosi™ (pilocarpine hydrochloride ophthalmic ...

View study designs and clinical data on Qlosi for presbyopia, and see which of your patients could benefit from Qlosi. Please see full Prescribing Information.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38216351/

Efficacy and Safety of CSF-1 (0.4% Pilocarpine ...

CSF-1, a low-dose pilocarpine ophthalmic solution, demonstrated superiority to vehicle in improving near vision in individuals with presbyopia without ...

4.

orasis-pharma.com

orasis-pharma.com/orasis-pharmaceuticals-strengthens-leadership-team-with-key-hires-to-support-the-launch-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4/

Orasis Pharmaceuticals Announces Novel Corrective ...

In clinical trials, presbyopia patients achieved their best results when taking Qlosi consecutively over two weeks. All adverse events ...

5.

optometrytimes.com

optometrytimes.com/view/aaopt-2024-qlosi-s-effectiveness-in-treatment-of-presbyopia

AAOpt 2024: Qlosi's effectiveness in treatment of presbyopia

The results showed that for the early presbyopes, 84.2% achieved 20/40 or better near vision on day 1 with up to twice daily dosing.

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2023/217836s000lbl.pdf

NDA 217836 Page 4 - accessdata.fda.gov

QLOSI was evaluated in 309 patients with presbyopia in two randomized, double-masked, vehicle-controlled studies (NEAR-1 and NEAR-2) of 15 days duration. The ...

7.

qlosi.com

qlosi.com/

Qlosi™ (pilocarpine ophthalmic solution) 0.4% | Blurry Near ...

Important Safety Information​​ Use caution when driving at night or performing hazardous activities in poor lighting. Qlosi may cause temporary dim or dark ...

8.

clearvisionforyou.com

clearvisionforyou.com/en-us/news-media-center/feature-stories/presbyopia-treatment-orasis/

Johnson & Johnson's Investment in QLOSI™ Eye Drops

Qlosi should not be administered while wearing contact lenses. Remove lenses prior to the installation of Qlosi and wait 10 minutes before reinsertion. Avoid ...

9.

qlosiecp.com

qlosiecp.com/tolerability

Tolerability | Qlosi™ (pilocarpine hydrochloride ophthalmic ...

Well-established safety and tolerability profile across 5 clinical trials: · Qlosi is contraindicated in presbyopia patients with known hypersensitivity to the ...