Soft Contact Lenses for Nearsightedness

(ARCTIC Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Myoptechs, Inc

Must not be taking: Antihistamines, Atropine

Disqualifiers: Astigmatism, Amblyopia, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 hour per lens

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new soft contact lenses to determine their effect on the thickness of the choroid in people with nearsightedness (myopia). It includes three different types of lenses, and researchers aim to understand how each one works in the short term. Ideal participants have been wearing glasses or soft contact lenses, have nearsightedness within a specific range, and have not used any myopia control treatments in the last two years. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance vision care for those with myopia.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use any medications that might affect the study results, like antihistamines or atropine eye drops. It's best to discuss your current medications with the study team to see if they might be a concern.

What prior data suggests that these prototype soft contact lenses are safe for people with myopia?

Studies have shown that the new soft contact lenses for nearsightedness are generally easy to use. Research indicates that these lenses are safe, with no serious problems reported. Some studies found that users experienced mild to moderate discomfort, similar to regular contact lenses. Designed to slow the progression of nearsightedness, these lenses work as intended. Overall, evidence suggests that the lenses are safe, with side effects similar to standard contact lenses. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these prototype soft contact lenses because they offer a new approach to managing nearsightedness. Unlike traditional options like glasses or standard contact lenses, these experimental lenses may provide improved vision correction by utilizing advanced lens materials or designs. This innovation has the potential to enhance comfort and vision quality, making daily wear more appealing and effective for people with nearsightedness. By exploring these new lenses, researchers hope to offer a more comfortable and efficient solution for vision correction that could surpass current options.

What evidence suggests that these prototype soft contact lenses could be effective for myopia?

This trial will compare three different designs of prototype soft contact lenses: Lens A, Lens B, and Lens C. Studies have shown that new types of soft contact lenses can effectively slow the progression of nearsightedness, or myopia. One study found that all three lens designs successfully slowed eye growth over six months while maintaining clear vision. Another study confirmed that these lenses, especially those specifically designed for myopia control, effectively managed vision changes. Additionally, wearing similar contact lenses for three years significantly slowed myopia progression compared to regular glasses. Overall, these lenses appear promising for managing nearsightedness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with near-sightedness (myopia) who are interested in testing how different prototype soft contact lenses affect the thickness of the choroid, a layer in the eye. Specific eligibility criteria details were not provided.

Inclusion Criteria

Are myopic with both eyes having a vertex corrected spherical equivalent non-cycloplegic refraction of at least -0.50 DS and no more than -4.50 DS

Have read (or be read to) and signed the information and consent form

Habitually wear soft contact lenses or are spectacle wearers with previous experience of soft contact lens wear

Exclusion Criteria

Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment

Are an employee of the Centre for Ocular Research & Education directly involved in this study (i.e. on the delegation log)

Participating in any concurrent clinical or research study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear each of the 3 prototype soft contact lenses for 1 hour to measure changes in choroidal thickness

1 hour per lens

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Prototype Soft Contact Lenses

Trial Overview

The study aims to measure changes in the choroidal thickness after wearing each of three different prototype soft contact lenses, referred to as Lens A, Lens B, and Lens C. Each lens will be worn for one hour.

How Is the Trial Designed?

Group I: Lens C Experimental Treatment 3 Interventions

Group II: Lens B Experimental Treatment 3 Interventions

Group III: Lens A Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Myoptechs, Inc

Lead Sponsor

University of Waterloo School of Optometry and Vision Science

Collaborator

Trials

1

Recruited

150+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9762188/

Randomized Trial of Soft Contact Lenses with Novel Ring ...

All 3 myopia control designs were effective at slowing axial elongation after 6 months of lens wear while providing good visual quality. Because EE produced ...

2.

contactlensjournal.com

contactlensjournal.com/article/S1367-0484(22)00068-6/fulltext

Controlling myopia progression with prototype soft contact ...

To evaluate efficacy and vision with two prototype soft contact lens (SCL; T1 and T2) designs optimized specifically for myopia control (MC)

3.

researchgate.net

researchgate.net/publication/363529315_Controlling_myopia_progression_with_prototype_soft_contact_lenses

(PDF) Controlling myopia progression with prototype soft ...

Objectives This study aims to compare the efficacy of peripheral add multifocal soft contact lenses (SCLs) (excluding bifocal SCLs) with single ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1367048424001966

Subjective impressions with myopia control contact lenses ...

The various optical lens designs that have been assessed and shown to have efficacy in slowing myopia include executive bifocals [15], progressive addition [16] ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/opo.13549?af=R

Three‐year myopia management efficacy of extended ...

Three years of wear with MYLO CL resulted in clinically significant slower myopia progression compared to the SV spectacle group.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02193555

Visual Performance of Prototype Contact Lens Designs

There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

7.

myopiaprofile.com

myopiaprofile.com/products/myopia-control-soft-contact-lenses

Myopia control soft contact lenses

This article provides advice comparing efficacy, best corrected acuity and accommodation outcomes in multifocal and myopia control soft contact lenses.

8.

reviewofmm.com

reviewofmm.com/soft-contact-lenses-with-novel-ring-focus-design-control-myopia-progression/

Soft Contact Lenses with Novel Ring Focus Design Control ...

Conclusions: The prototype contact lenses met the design intent; EE was more efficacious in slowing axial elongation than DF with comparable ...