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

Trial Summary

What is the purpose of this trial?

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 children. Additionally, the study will learn about the compliance and safety of specialized soft contact lens wear in children. The main questions it aims to answer are: Does wearing specialized soft contact lenses daily slow myopia progression and axial elongation? What visual/ocular problems do participants have when wearing specialized soft contact lenses? Researchers will compare two soft contact lenses to see if specialized soft contact lens wear works to treat childhood myopia progression. Participants will 1. Wear either a single type of soft contact lens or two types of soft contact lenses at alternate times daily full time in both eyes for one year. 2. Visit the clinic at 2 weeks, 1 month, 3 months, 6 months, and 12 months for checkups and tests 3. Keep a diary of the lens-wearing times.

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 data supports the effectiveness of the treatment Specialized Soft Contact Lens 1 and Specialized Soft Contact Lens 2 for nearsightedness?

Research shows that specialized soft contact lenses with novel designs can help control the progression of myopia (nearsightedness) by altering how light focuses on the eye, which is similar to the approach used in the trial. ^{1 2 3 4 5}

Is it safe to use specialized contact lenses for nearsightedness?

Contact lenses, including specialized soft contact lenses, are generally safe for correcting vision problems, but they can sometimes cause eye issues. Extended-wear soft contact lenses have a higher risk of complications compared to daily wear lenses, especially in people with certain conditions. It's important to follow proper lens care and wear guidelines to reduce risks. ^{6 7 8 9 10}

How do Specialized Soft Contact Lenses for Nearsightedness differ from other treatments?

Specialized Soft Contact Lenses for Nearsightedness are unique because they may incorporate novel designs like noncoaxial ring-focus, which can help control the progression of myopia (nearsightedness) more effectively than traditional single-vision lenses. This design aims to enhance both efficacy in slowing myopia progression and vision quality. ^{1 11 12 13 14}

Research Team

Safal Khanal, OD, PhD

Principal Investigator

Unversity of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized Trial of Soft Contact Lenses with Novel Ring Focus for Controlling Myopia Progression. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of multifocal soft contact lenses on peripheral refraction. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Protection of the ocular surface after keratoprosthesis surgery: the role of soft contact lenses. [2017]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Visual performance of myopia control soft contact lenses in non-presbyopic myopes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of two different orthokeratology lenses and defocus incorporated soft contact (DISC) lens in controlling myopia progression. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Nonulcerative complications of contact lens wear. Relative risks for different lens types. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of adverse events with daily disposable hydrogels and spectacle wear: results from a 12-month prospective clinical trial. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Orthokeratology vs. spectacles: adverse events and discontinuations. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Contact Lens Safety for the Correction of Refractive Error in Healthy Eyes. [2023]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Wavefront and accommodation parameters under different conditions of correction in myopia and hyperopia]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

On-eye performance of custom wavefront-guided soft contact lenses in a habitual soft lens-wearing keratoconic patient. [2022]

13. Poland pubmed.ncbi.nlm.nih.gov

[Use of contact lenses in children with severe myopia]. [2006]

14. Brazil pubmed.ncbi.nlm.nih.gov

[Visual performance in myopic correction with spectacles and soft contact lenses]. [2019]