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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a new type of contact lens affects blood flow in the eye and comfort for individuals with nearsightedness. Participants will wear two types of lenses: an experimental lens with a special design called the Myopic Defocus Soft Lens Design (MDSL) and a regular lens already available on the market. The study will assess changes in the eye and gather feedback on comfort and vision after participants wear each lens for a week. Ideal candidates are healthy young adults with nearsightedness between -0.50 and -4.00D, no significant astigmatism, and good vision in both eyes. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance vision care for many.

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 prior data suggests that these contact lenses are safe for near-sighted individuals?

Research has shown that contact lenses designed to reduce nearsightedness, such as the Myopic Defocus Soft Lens (MDSL), have generally been well-received in past studies. These studies, mostly involving children, indicate that such lenses can effectively slow the progression of nearsightedness. Importantly, no major safety issues were reported during their use.

The Single Vision Soft Lens (SVSL) is already popular in places like the US and Canada, indicating its safety and effectiveness for correcting vision without major safety concerns.

In summary, both types of lenses appear safe based on previous research and their market use. However, individual experiences may vary, so it's important to consider any specific sensitivities or conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Myopic Defocus Soft Lens Design (MDSL) because it introduces a unique approach to managing near-sightedness. Unlike standard single-vision lenses that solely correct distance vision, MDSL incorporates a special myopic defocus zone. This design includes a central zone for clear distance vision, surrounded by a convex area that intentionally creates a defocus effect. This feature is believed to help slow down the progression of myopia by altering the way light is focused on the retina. Such an innovative approach could offer a dual benefit: correcting vision while potentially managing the condition's advancement.

What evidence suggests that this trial's contact lenses could be effective for near-sightedness?

Research shows that special soft contact lenses, called myopic defocus soft lenses (MDSL), can help slow down nearsightedness, especially in children and young teens. Studies have found that wearing these lenses daily can significantly reduce the eye's elongation, a main cause of worsening nearsightedness. For example, one study found that using MDSL led to a 25% decrease in the progression of nearsightedness. While most research focuses on children, these results suggest that MDSL might also help young adults by managing changes in their eyes. In this trial, participants will be assigned to either the MDSL arm or the single vision soft lens design (SVSL) arm. Thus, MDSL could be a promising way to control nearsightedness. ^{1 2 3 6 7}

Who Is on the Research Team?

Langis Michaud, OD MS

Principal Investigator

Universite de Montreal

Are You a Good Fit for This Trial?

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

Smoking (tobacco or marijuana)

Addiction to drugs or alcohol

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3888618/

Defocus Incorporated Soft Contact (DISC) lens slows ... The daily wearing of DISC lens significantly slowed myopia progression and axial elongation in Hong Kong schoolchildren.

2. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00238-6/fulltext

One-Year Myopia Control Efficacy of a New Defocus ... The primary outcome was the 1-year change in SER from baseline to 12 months. Secondary outcomes included changes in axial length (AL), ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1888429624000219

Real–world outcomes on myopia management efficacy of ... DSDO showed more stable myopia control effect comparing to DIMS, especially in groups of SER≤–2.0D sub–groups and older patients. DSDO showed initial potential ...

4. bjo.bmj.com bjo.bmj.com/content/early/2025/09/23/bjo-2025-327471

Effect of daily disposable Defocus Incorporated Soft ... The study has shown that DISC lens use resulted in a significant myopia control effect in children and young adolescents aged 7–11 years. This ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/opo.13501

Myopia control using a modified optical defocus soft ... Defocus Incorporated Soft Contact (DISC) lenses with +2.50 D myopic defocus reduced myopia progression by 25% in a previous randomised ...

6. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1416286/full

Real-world outcomes of Defocus Incorporated Multiple ... The study demonstrated that DIMS lenses could retard axial elongation, with the effect sustained with increased duration of lens wear.

7. nature.com nature.com/articles/s41598-023-32700-7

Long-term myopia control effect and safety in children ... Defocus incorporated soft contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: A 2-year randomized clinical trial.