CLINICAL TRIAL

Control Lens B for Myopia

Waitlist Available · 18 - 65 · All Sexes · Minnesota, MN

This study is evaluating whether a silicone hydrogel contact lens can be worn for a month.

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About the trial for Myopia

Treatment Groups

This trial involves 2 different treatments. Control Lens B is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control Lens B
DEVICE
Lens A (Test)
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Control Lens B
DEVICE
Lens A (Test)
DEVICE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lens A (Test)
2021
N/A
~40

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
resourceful, and displays initiative Is able to work independently;shows enthusiasm and takes initiative;able to take direction and carry out assignments The individual is willing and able to follow instructions and maintain the appointment schedule show original
I have had a full eye examination in the previous two years. show original
The subject has no health condition or medication that would prevent them from wearing contact lenses, as determined by the investigator. show original
I anticipate being able to wear the study lenses for 8 hours a day, 6 days a week. show original
I usually spend around 6 hours a day using digital devices such as a computer, laptop, tablet, e-reader, and smartphone. show original
Has a corrected visual acuity of 20/40 or better in each eye The person can have a refractive astigmatism no higher than -0.75DC in each eye and a corrected visual acuity of 20/40 or better in each eye. show original
Must be at least 18 years of age and no older than 35 years old, and have the legal capacity to volunteer. show original
I have read and signed an information consent letter. show original
Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand;
This person can have surgery to improve their vision to at least 20/30 Snellen show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 27
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 27.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Control Lens B will improve 1 primary outcome in patients with Myopia. Measurement will happen over the course of Day 27.

Subjective Ratings on Lens handling on removal
DAY 27
Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 0- very easy, 10 -very difficult)

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is myopia?

In a recent study, findings showed that myopia was an increasingly present problem among Chinese children and adolescents, with high prevalence for far-sightedness. We also found that there was an association between myopia and obesity, dyslipidemia and DM.

Anonymous Patient Answer

What causes myopia?

The condition of the eye (primarily, intraocular pressure), the light environment, a number of genes and hormones, the brain, and many other factors can determine the amount of vision achievable. Myopia is a common condition with a range of causes.

Anonymous Patient Answer

What are common treatments for myopia?

Myopia and the management of myopic refractive errors are well understood and have traditionally been treated primarily with myopic contact lenses. In many places, the use of ophthalmic eyeglasses have become common in the management of myopia. At the time of eye exam, patients are often advised to wear eyeglasses for prevention of amblyopia and to increase near-point clarity of distance vision. However, current studies evaluating the effect of myopic eyeglasses on distance vision or near-point clarity provide mixed results.

Anonymous Patient Answer

How many people get myopia a year in the United States?

The number of people who develop myopia in the United States is about half that of people with diabetes and one-fifth that of people who have heart disease. The increased prevalence of myopia among children and adolescents underscores the importance of preventive efforts.

Anonymous Patient Answer

What are the signs of myopia?

Any of these symptoms can indicate the presence of either myopia or astigmatism. An ophthalmologic examination is recommended to clarify if the cause is myopia or astigmatism.

Anonymous Patient Answer

Can myopia be cured?

Myopia cannot be (or is not) cured by any of the currently available therapies including refractive surgery. Myopathy appears to be a separate clinical entity, while asthenopia is a more common symptom. Neither myopia, myopathy nor asthenopia can be cured.

Anonymous Patient Answer

Is control lens b safe for people?

There is a general acceptance amongst the reflux lens providers and their patients that the b lens has a wider dynamic range than expected. It should be used with caution.

Anonymous Patient Answer

Have there been other clinical trials involving control lens b?

There have not been any previous clinical trials with control lenses. No conclusive evidence has been found when performing refraction on children younger than 6 years of age with myopia. There have been very few uncontrolled case series involving the use of children with severe myopia to demonstrate the refractive benefits of other control lens combinations. There are also few controlled studies documenting the efficacy of using other control lenses for myopic children during their active refractive growth period. There are currently no guidelines in existence for when and how well children with high myopia can participate in clinical studies.

Anonymous Patient Answer

What are the common side effects of control lens b?

In the current study, side effects of control lens b and silicone hydrogel contact lenses in the long term were moderate or mild in most cases.

Anonymous Patient Answer

What is control lens b?

The lens b of the NAGRA group was close to the target and lens b was independent of lens power. However, we recommend that doctors keep long-term follow up of visual functions, such as the reading and vision scores to look at the lens image displacement, and we need a prospective study to investigate whether there is an increased risk of developing cataracts in patients with a history of myopia who have undergone lens implantation.

Anonymous Patient Answer

Who should consider clinical trials for myopia?

This research suggests that both low and high myopia are equally common in India. The majority in this research did not seek myopia treatment in any form. The low willingness of treating myopia is quite alarming. This suggests a larger number of cases with untreated myopia. These numbers warrant consideration for treatment options such as refractive surgery and medical therapy such as atropine. The low willingness to seek treatment may be a problem for future management of myopia in India, as patients may be wary of treatment options.

Anonymous Patient Answer

How does control lens b work?

The control lens can function well for an extended period with little deterioration of the refractive power. This means that the control lens can be more comfortable for the patient, avoiding a refractive error which can be corrected by lenses.

Anonymous Patient Answer
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