Contact Lenses for Near-sightedness

Overseen By Langis Michaud, OD MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Université de Montréal

Must not be taking: Blood pressure medications

Disqualifiers: Corneal dystrophy, Smoking, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable soft contact lens (MDSL) in a group of healthy young myopic adults (18-35 years; myopia -1.00D to -4.00D; all genders). It will also learn about the acceptance of this visual correction modality compared to regular contact lenses. The main questions to be answered are: * To evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus after one week of MDSL wear. * To evaluate changes in choroidal thickness at the macular level after one week of MDSL wear. * To evaluate the visual comfort provided by this MDSL design using a questionnaire. Researchers will compare the MDSL to a daily disposable single vision soft lens (SVSL) used to correct myopia to determine if the addition of a defocus area makes a difference in the retinal response to the visual signal. Participants will be required to * Wear both MDSL and SVSL for one week each, in a random order. * Read letters to measure visual acuity * Have a deep scan of their retina with an optical coherence tomography (OCT) device * Rate the comfort and vision provided by both devices using a questionnaire.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've recently taken medications affecting blood pressure or if you use topical eye medications.

What data supports the effectiveness of the treatment Myopic Defocus Soft Lens Design (MDSL) for near-sightedness?

Research shows that contact lenses with designs that create myopic defocus, like the Myopic Defocus Soft Lens Design (MDSL), can help control the progression of myopia (near-sightedness) by affecting how light focuses on the retina. Studies comparing different lens designs, including those with ring-focus and dual-focus, suggest that these lenses can be effective in managing myopia progression. ^{1 2 3 4 5}

Is it safe to use contact lenses for near-sightedness?

Research on defocus incorporated soft contact lenses (DISC lenses) and other similar designs shows they are generally safe for controlling myopia (near-sightedness) in children and adults. These studies focus on safety and effectiveness, indicating that these lenses are safe for human use. ^{1 2 3 5 6}

How is the Myopic Defocus Soft Lens Design (MDSL) treatment different from other treatments for near-sightedness?

The Myopic Defocus Soft Lens Design (MDSL) is unique because it uses a special design to create myopic defocus (a way to focus light in front of the retina) which can help slow down the progression of near-sightedness. This is different from traditional single vision lenses that only correct vision without addressing myopia progression. ^{1 2 3 4 7}

Research Team

Langis Michaud, OD MS

Principal Investigator

Universite de Montreal

Eligibility Criteria

This trial is for healthy young adults aged 18-35 with mild to moderate near-sightedness (myopia between -1.00D and -4.00D). Participants must be willing to wear two types of soft contact lenses, each for one week, and undergo eye scans.

Inclusion Criteria

Astigmatism ≤ 1.00 D

Binocular acuity of 6/6 or better

Myopia between -0.50 and -4.00D

Exclusion Criteria

I have taken medication that affects blood pressure in the last 3 months.

Addiction to drugs or alcohol

I have a corneal condition affecting my eye's surface.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Measurement

Initial measurements of deep and superficial plexus blood vessel density and choroidal thickness are taken with an angiographic optical coherence tomograph (OCT-A Triton, Topcon USA).

1 day

1 visit (in-person)

Treatment

Participants wear each type of contact lens (MDSL and SVSL) for one week each, in a random order. Measurements are repeated at the end of each week.

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in retinal blood flow and choroidal thickness after wearing the contact lenses.

1 week

Treatment Details

Interventions

• Myopic defocus soft lens design (MDSL)
• Single vision soft lens design (SVSL)

Trial Overview The study tests if a myopic defocus soft lens design (MDSL) affects retinal blood flow and choroidal thickness compared to standard single vision lenses (SVSL). It includes wearing both lens types, eye scanning with OCT technology, and completing comfort questionnaires.

Participant Groups

Group I: Myopic defocus soft lens design (MDSL) Experimental Treatment 1 Intervention

This arm involves the wear of a daily disposable soft contact lens (nesofilcon A) designed with a myopic defocus zone. This is a 14.2mm total diameter lens with a 4.2mm central zone for distance vision correction. This is followed by an abrupt transition zone of 1.2mm with no optical power. Then a higher convex power zone covers the surface to the edge of the optical zone (8mm). The rest of the lens (up to 14.2 mmOAD) supports the lens on the eye surface and has no power nor refractive effect. The power of the add area is calibrated to the central power to achieve a net add power of +5D. For example: -1.00D central power is surrounded by a +6D convex area; -2D is surrounded by a +7D area, and so on.)

Group II: Single vision soft lens design (SVSL) Active Control 1 Intervention

This arm involves the wear of a daily disposable soft contact lens (nesofilcon A) designed as a regular optical device to compensate for refractive error. In the case of this study, this lens will be made available from -1.00D to -4.00D. This lens is already in regular use in the US (K113703) and Canadian markets. Its design includes a central optical zone of 8mm that is powered to correct distance vision. The rest of the lens is supported on the ocular surface and has no power.

Myopic defocus soft lens design (MDSL) is already approved in European Union, United States for the following indications:

Approved in European Union as MDSL for:

• Myopia control
• Retardation of myopia progression

Approved in United States as MDSL for:

• Myopia control
• Retardation of myopia progression

Who Is Running the Clinical Trial?

Université de Montréal

Lead Sponsor

Trials

223

Recruited

104,000+

Bausch & Lomb Incorporated

Industry Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University

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]

Bifocal soft contact lenses with a distance center design do not provide the same myopic defocus to the peripheral retina as corneal reshaping contact lenses, despite some statistical similarities in central vision performance.

The study involved 14 myopic subjects and found that corneal reshaping lenses produced a more myopic peripheral optical profile compared to bifocal lenses, suggesting that different lens designs have distinct effects on peripheral vision, which may require more advanced measurement techniques to fully understand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral optics with bifocal soft and corneal reshaping contact lenses. Ticak, A., Walline, JJ.[2022]

The study involved 25 young adults with myopia, and it found that certain spherical soft contact lenses (SCLs) can significantly reduce peripheral hyperopia, which may help in slowing myopia progression.

Specifically, lenses like Acuvue 2, Biofinity, and Air Optix Night & Day Aqua showed myopic shifts in peripheral defocus, while PureVision2 did not affect peripheral defocus, indicating that the design of SCLs can influence how they impact myopic eyes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spherical Soft Contact Lens Designs and Peripheral Defocus in Myopic Eyes. Moore, KE., Benoit, JS., Berntsen, DA.[2018]

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 study involving 33 juvenile myopes, multifocal soft contact lenses (MFSCLs) provided satisfactory distance visual acuity without significant differences in high and low contrast visual acuity compared to single vision lenses after one month of use.

While MFSCLs increased certain optical aberrations, they did not adversely affect overall visual quality, although they did lead to more halos compared to single vision spectacles, indicating a trade-off in visual perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual quality of juvenile myopes wearing multifocal soft contact lenses. Huang, X., Wang, F., Lin, Z., et al.[2022]

Both defocus incorporated soft contact (DISC) lenses and orthokeratology (OrthoK) lenses effectively reduced the increase in ocular axial length in myopic children over a 12-month period, showing better results than traditional prescription glasses.

The safety profiles of both lens types were similar, with no significant differences in the incidence of corneal and conjunctival complications, indicating that both options are safe for managing myopia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Observational Comparison of the Safety and Effectiveness of Myopic Children Wearing Defocus Incorporated Soft Contact Lenses or Orthokeratology Lenses]. Ma, W., Yang, B., Wang, X., et al.[2023]

In a study involving 10 young myopic adults, different multizone contact lenses were tested, showing that lenses like the concentric-ring dual-focus and RingBoost designs introduced significantly more myopic defocus across the pupil compared to single vision lenses, with up to 84% of the pupil area being myopic at certain vergences.

The effectiveness of these multizone lenses in creating myopic defocus varied based on their geometric design and the viewing conditions, indicating that lens design plays a crucial role in controlling myopia progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of zone geometry on the introduction of myopic defocus in young adult eyes wearing multi-zone lenses. Sah, RP., Meyer, D., Jaskulski, M., et al.[2023]

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

Peripheral optics with bifocal soft and corneal reshaping contact lenses. [2022]

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

Spherical Soft Contact Lens Designs and Peripheral Defocus in Myopic Eyes. [2018]

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

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

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

Visual quality of juvenile myopes wearing multifocal soft contact lenses. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Observational Comparison of the Safety and Effectiveness of Myopic Children Wearing Defocus Incorporated Soft Contact Lenses or Orthokeratology Lenses]. [2023]

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

Impact of zone geometry on the introduction of myopic defocus in young adult eyes wearing multi-zone lenses. [2023]