Qlosi for Presbyopia
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.12345Why 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.56789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Qlosi™ BID OD/OS and are monitored for improvement in presbyopic symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Qlosi
Find a Clinic Near You
Who Is Running the Clinical Trial?
Southern College of Optometry
Lead Sponsor