Specialized Contact Lenses for Nearsightedness

(WINK Trial)

Overseen By Sindhu Gurrala, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Systemic medications

Disqualifiers: Ocular diseases, Corneal disorders, Strabismus, others

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

Compensation: Varies

Number of Visits: 2

Duration: 52 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether wearing special contact lenses daily can slow the progression of nearsightedness (when faraway objects appear blurry) in children. Researchers aim to determine if these lenses can manage myopia (another term for nearsightedness) and if children can wear them safely every day. Families with children who have worn regular soft contact lenses for at least a week and have mild to moderate nearsightedness may be suitable for this trial. Participants will wear various specialized soft contact lenses and attend regular checkups over a year. As an unphased trial, this study offers families the opportunity to contribute to important research that could enhance vision care for children.

Will I have to stop taking my current medications?

The trial excludes participants who are currently using medications that may affect contact lens wear or eye health. If you are taking such medications, you may need to stop them to participate in the trial.

What prior data suggests that these specialized contact lenses are safe for children?

Research has shown that soft contact lenses designed to control nearsightedness are generally safe and well-tolerated in children. A large study found that children wearing these lenses experienced very few complications, similar to adults. For Specialized Soft Contact Lens 1, about 12.2% of children had some eye-related issues, but serious problems were rare, with minor inflammation occurring at a rate of just 0.66% per year.

For Specialized Soft Contact Lens 2, the results were similar. Studies have shown these lenses effectively slow the progression of nearsightedness with a low risk of complications. Overall, both types of contact lenses appear to be a safe option for managing nearsightedness in children, based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these specialized contact lenses for nearsightedness because they offer a unique approach by combining two different types of lenses daily. Unlike traditional contact lenses that are worn consistently throughout the day, these lenses involve switching types partway through, potentially offering better control over myopia progression. This innovative method could provide a more tailored and effective management of nearsightedness in children, addressing a growing need for solutions that go beyond standard single-vision lenses.

What evidence suggests that these specialized contact lenses are effective for slowing nearsightedness in children?

This trial will evaluate the effectiveness of specialized soft contact lenses for nearsightedness in children. Research has shown that special soft contact lenses can significantly slow the progression of nearsightedness (myopia) in children. One study found that MiSight contact lenses reduced myopia progression by 71% over several years. These lenses alter how light focuses on the back of the eye, helping to control eye growth and vision changes. Studies also indicate that these lenses are generally safe and comfortable for children. Other research highlights that dual-focus and high-add multifocal lenses are also effective in slowing myopia. Children using these special lenses reported feeling as comfortable and satisfied as those wearing regular lenses. In this trial, participants in Group A will wear two different types of specialized soft contact lenses at different times of the day, while the control group will wear standard single-vision soft contact lenses. ^{5 6 7 8 9}

Who Is on the Research Team?

Safal Khanal, OD, PhD

Principal Investigator

Unversity of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for children with near-sightedness. Participants will wear specialized soft contact lenses daily to see if it slows down their myopia. They must be able to visit the clinic for checkups over a year and keep a diary of when they wear the lenses.

Inclusion Criteria

Best-corrected visual acuity of 20/25 (+0.10 logMAR) or better in each eye

Less than 1.00 D of astigmatism or anisometropia

History of soft contact lens wear for at least one month

Exclusion Criteria

History of premature (less than 3.3 lb) or preterm birth (earlier than 30 weeks)

Subjects exhibiting poor personal hygiene that may affect the compliance of contact lens wear

Known allergy to fluorescein, benoxinate, proparacaine, or tropicamide

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear specialized soft contact lenses daily for one year to slow myopia progression

52 weeks

Visits at 2 weeks, 1 month, 3 months, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Specialized Soft Contact Lens 1
• Specialized Soft Contact Lens 2

Trial Overview The study tests two types of specialized soft contact lenses, worn at different times, to determine their effectiveness in treating childhood myopia progression. Kids will switch between these lenses throughout the day for one year.

How Is the Trial Designed?

Group I: Group A Experimental Treatment 1 Intervention

Children who are randomized to this group will wear one type of daily use, daily disposable, single-vision soft contact lens for at least four hours starting in the afternoon (after school) and another type of daily use, daily disposable, single-vision soft contact lens for the remainder of the time daily for one year.

Group II: Control group Placebo Group 1 Intervention

Children who are randomized to this group will wear daily use, daily disposable, single-vision soft contact lenses full time for one year. Contact lenses will be worn for a minimum of 10 hours per day.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

In a study involving 581 myopic children aged 7-15 years wearing daily disposable hydrogel contact lenses, no significant or serious ocular adverse events were reported over 816 patient years, indicating a high safety profile for these lenses.

The overall rate of ocular adverse events was low at 10.6 per 100 patient years, with only two non-significant corneal infiltrative events, suggesting that daily disposable soft contact lenses are a safe option for children compared to a lower incidence of 1.8 per 100 patient years for spectacle wearers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. Cheng, X., Brennan, NA., Toubouti, Y., et al.[2021]

In a study involving 34 young myopic adults, both single-vision (SV) and multifocal (MF) soft contact lenses (SCLs) caused a hyperopic shift in peripheral refraction, indicating a change in how light is focused in the eye.

However, MF SCLs resulted in a relative myopic shift in peripheral refraction compared to SV SCLs, which may help explain why MF lenses are associated with slower progression of myopia in young individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of multifocal soft contact lenses on peripheral refraction. Kang, P., Fan, Y., Oh, K., et al.[2019]

In a 6-month study involving 199 myopic children, prototype contact lenses designed for enhancing efficacy (EE) significantly reduced axial elongation compared to single-vision lenses, indicating they are effective in slowing myopia progression.

Both the enhancing efficacy (EE) and dual-focus (DF) lenses showed similar visual performance, while the enhancing vision (EV) lenses had comparable efficacy to DF but did not perform as well in slowing axial elongation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Soft Contact Lenses with Novel Ring Focus for Controlling Myopia Progression. Cheng, X., Xu, J., Brennan, NA.[2022]

In a study of 40 myopic patients, visual performance was evaluated using spectacles and three types of soft contact lenses, revealing that wavefront analysis provided more sensitive measurements of visual function compared to traditional methods like high contrast visual acuity and contrast sensitivity.

While there were differences in refractive components between the contact lenses, overall visual performance in terms of acuity and contrast sensitivity was not significantly different among spectacles and the three contact lenses, indicating that all options may be similarly effective for myopic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Visual performance in myopic correction with spectacles and soft contact lenses]. Barth, B., Alves, MR., Kara-José, N.[2019]

Extended-wear soft contact lenses are associated with a significantly higher risk of complications compared to gas-permeable hard lenses, with a relative risk of 2.7, indicating they may not be the safest option for new users.

Daily wear soft contact lenses also present risks, particularly for users with toxic or hypersensitivity disorders, where the relative risk is as high as 5.9, suggesting careful selection and monitoring of lens types is crucial for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonulcerative complications of contact lens wear. Relative risks for different lens types. Stapleton, F., Dart, J., Minassian, D.[2019]

Contact lenses are FDA-regulated medical devices that provide a safe and effective way to correct refractive errors for approximately 45 million Americans.

The materials used in contact lenses and the wear and care practices significantly influence the risk of complications, such as corneal inflammation and microbial keratitis, highlighting the importance of proper lens management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact Lens Safety for the Correction of Refractive Error in Healthy Eyes. Rhee, MK., Jacobs, DS., Dhaliwal, DK., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10076805/

Effectiveness of myopia control interventions - PubMed Central The results showed that MiSight contact lenses slowed the progression of myopia over a period of 6 years with a total reduction of 71% over the subsequent 3- ...

2. withpower.com withpower.com/trial/phase-myopia-9-2024-5e732

Specialized Contact Lenses for Nearsightedness The goal of this clinical trial is to learn if daily brief periods of specialized soft contact lens wear work to slow the progression of nearsightedness in ...

3. mykidsvision.org mykidsvision.org/knowledge-centre/soft-contact-lenses-for-myopia-control-in-children

Soft contact lenses for myopia control in children The research reveals myopia control soft contact lenses to be effective, safe and well tolerated in children from age 7-8. However, age alone should not be the ...

4. cureus.com cureus.com/articles/424878-efficacy-of-contact-lens-based-interventions-in-slowing-myopia-progression-in-children-a-systematic-review

Efficacy of Contact Lens-Based Interventions in Slowing ... Overall, contact lens interventions, particularly dual-focus and high-add multifocal soft lenses, are effective and safe for slowing childhood ...

5. myopiaprofile.com myopiaprofile.com/articles/children-soft-contact-lenses-satisfaction-handling-vision

How satisfied are children wearing full-time daily ... Six year data from the MiSight® 1 day study showed similar satisfaction, comfort and vision outcomes to children wearing single vision ...

6. myopiaprofile.com myopiaprofile.com/articles/children-soft-contact-lenses-adverse-events

How often do children wearing soft contact lenses ... Some studies of myopia control with SCLs have not reported safety outcomes, potentially resulting in underreporting of adverse events.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7839756/

Adverse event rates in the retrospective cohort study of safety ... There were 122 potential ocular AEs observed from 118/963 (12.2%) subjects; the annualised rate of non‐infectious inflammatory AEs was 0.66%/year (95% CI 0.39– ...

8. reviewofmm.com reviewofmm.com/largest-ever-study-on-childrens-soft-contact-lenses-shows-low-complications/

Largest-Ever Study on Children's Soft Contact Lenses ... The largest-ever retrospective study of its kind has found very low complication rates in children who wear soft contact lenses, similar to rates in adults.

9. sciencedirect.com sciencedirect.com/science/article/pii/S136704842300053X

Six years of wearer experience in children participating in a ... The dual-focus optics included in the MiSight® 1 day lenses successfully achieved myopia control without lowering subjective ratings when fitted to neophytes.