CooperVision has completed patient enrollment in its global MiSight 1 day post-approval clinical studies (PAS) in the United States and China.
What’s the significance of this?
These studies represent the longest international clinical evidence program ever undertaken for soft contact lens-based myopia control intervention in children, including both randomized controlled efficacy trials (RCTs) and large-scale safety registries.
Nice! Now before we talk trials, refresh me on MiSight.
What it is: FDA-approved in 2019, this is the first and only soft contact lens for slowing myopia progression among pediatric patients.
- Its features include an omafilcon A soft (hydrophilic) lens material and a unique optical design (dual-focus)
Its indication: For daily wear to correct myopic ametropia and slow myopia progression among pediatric patients (between age 8-12 at the start of treatment) with non-diseased eyes.
- Other criteria: a refraction of -0.75 to -4.00 diopters (D; spherical equivalent) with ≤ 0.75 D of astigmatism
And what else is unique about this lens?
Most notably, MiSight is embedded with ActivControl Technology, a specialty contact lens technology for pediatric patients that both corrects vision and slows myopia progression for its target patient age group.
How it works: This tech is specifically designed to reduce myopia progression by controlling axial length and refractive error—potentially helping to "reduce the risk of myopia-related vision complications” later in life.
Alrighty, now tell me more about these clinical studies.
The combined PAS programs (NCT05285553 [PAS001/BC] and NCT05285527 [PAS002]) span more than 100 clinical sites and include over 3,000 children (aged 8-12 years old), with participants in the multiyear-year studies representing populations across the U.S. and China.
PAS001/BC is a multicenter, parallel-group, controlled, double-masked RCT with a total duration of 4 years enrolling 2,400 participants. The study is divided into two parts:
- Part 1: Evaluating the effectiveness of MiSight 1 day in slowing myopia progression over 3 years in a U.S. population.
- Subjects in Part 1 will wear MiSight 1 day lenses or Proclear 1 day lenses.
- Part 2: Assessing the stability of the effectiveness result over a 1-year post-treatment period.
- All subjects in Part 2 will wear Proclear 1 day lenses and subjects and investigators will remain masked from Part 1.
And that second trial?
PAS002 is a prospective post-approval study of safety in a U.S. study population. Consecutive subjects receiving the MiSight 1 day lens, will be prospectively offered to participate in the study.
Note: Safety data from PAS001 will be used to supplement this safety study.
Are there any differences in the cohorts of the two studies?
One key differentiation: PAS001/BC participants must have a spherical equivalent refractive error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye.
- Comparatively: Those in PAS002 require a SERE at baseline between -0.50 D and -7.00 D.
Let’s dig into the outcome measures in PAS001/BC.
Primary outcome measures:
- Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic autorefraction in diopters
- In Part 2: the mean difference between the Part 1 MiSight 1 day and control lens groups over 1 year post-treatment will be compared
- Mean difference in axial length change from baseline
- In Part 2: the mean difference in rate of axial length change between the Part 1 MiSight 1 day and control lens groups over 1 year post-treatment will be compared
Secondary outcome measures include:
- Percentage of subjects with no appreciable myopic progression (-0.25D change or less)
- Visual symptoms and the effects on activities of daily living.
Let’s dig into the outcome measures in PAS002.
The primary outcome measure is the incidence of microbial keratitis (MK) while the secondary outcome measures include the incidence of:
- Peripheral infiltrative keratitis/non-infectious ulcers
- Non-infectious infiltrative keratitis
- Loss of best-corrected visual acuity (BCVA) ≥2 lines for any adjudicated adverse event
And when can we expect updates on these studies?
Final data is anticipated on a rolling basis between 2027 and 2030.
Any comments from CooperVision as of yet?
“As clinicians, we all want long-term, real-world data that mirrors how myopia control is actually practiced,” noted Jennifer Palombi, OD, FAAO, director, Professional Affairs, Americas, CooperVision.
- “MiSight 1 day was built on a strong foundation of clinical evidence, and this next phase will add meaningful insights that can help eyecare professionals feel even more confidence when managing pediatric myopia and guiding families through long-term care decisions,” she added.
In related news: Check out our previous coverage of 7-year clinical data on the efficacy of MiSight 1 day soft contact lenses for myopia control.
Is there any other recent news from CooperVision to keep in mind?
Indeed. Most recently, the company launched a new 180-pack for MyDay Energys daily contact lenses, which is the only 1-day lens with a single-vision aspheric design and material technology to help eye tiredness and dryness linked to digital device use.