Soft Contact Lenses for Near-sightedness

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CooperVision International Limited (CVIL)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate and compare two types of soft contact lenses, Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere, for individuals with near-sightedness. Participants will try each lens for a short period to determine which performs better in comfort and vision clarity. The trial seeks individuals who regularly wear soft contact lenses and have a prescription between -1.00 and -6.00 for each eye. Those who consistently have difficulty seeing distant objects clearly and are accustomed to wearing contacts might be a good fit for this study. As an unphased trial, it offers the opportunity to contribute to research that could enhance contact lens options for people with near-sightedness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using any medications that would interfere with contact lens use, you may not be eligible to participate.

What prior data suggests that these soft contact lenses are safe for near-sightedness?

Research has shown that both Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere contact lenses are generally safe for use. These lenses are approved for daily wear, indicating a strong safety record.

The Biomedics 1 Day Extra Sphere, made from ocufilcon D, is designed for nearsighted individuals and is well-tolerated. Studies indicate it provides clear vision without major side effects.

Clariti 1 Day Sphere, made from somofilcon A, allows more oxygen to reach the eye, promoting eye health and comfort. It also offers UV protection, adding extra safety.

Both lenses are disposable and intended for one-day use, reducing the risk of infection and other issues. Users typically report good comfort and clear vision with few negative effects.12345

Why are researchers excited about this trial?

Unlike traditional contact lenses for near-sightedness, which often focus solely on correcting vision, the lenses being studied, Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere, offer unique material compositions. Lens 1 uses ocufilcon D, a hydrogel material known for its comfort, while Lens 2 utilizes somofilcon A, a silicone hydrogel that allows more oxygen to reach the eye, potentially enhancing eye health and comfort over prolonged use. Researchers are excited because these materials could provide better comfort and eye health benefits compared to conventional daily lenses, making it easier for people with near-sightedness to maintain eye health while enjoying clear vision.

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

In this trial, participants will test two types of soft contact lenses for near-sightedness. Research has shown that Biomedics 1 Day Extra Sphere contact lenses effectively correct near-sightedness, a condition where distant objects appear blurry. These lenses improve vision by properly focusing light in the eyes. Clariti 1 Day Sphere lenses, another option in this trial, have also been found to slow the progression of near-sightedness. Specifically, studies showed they reduced vision decline by up to 59% over three years. Both types of lenses are designed for comfort and effectiveness, with users reporting good vision correction and manageable side effects.36789

Who Is on the Research Team?

LJ

Lyndon Jones, PhD FCOptom

Principal Investigator

Centre for Ocular Research and Education

Are You a Good Fit for This Trial?

This trial is for adults over 18 who already use soft contact lenses and have mild to moderate near-sightedness, with prescriptions between -1.00DS to -6.00DS and astigmatism up to -1.00DC in each eye. Participants must be able to see clearly with the study lenses and keep scheduled appointments.

Inclusion Criteria

Have understood and signed an information consent letter
Are willing and able to maintain the appointment schedule
Are an adapted soft contact lens wearer
See 3 more

Exclusion Criteria

Are participating in any concurrent clinical or research study
Have a systemic condition that would contraindicate contact lens use
Have known sensitivity to the diagnostic fluorescein sodium to be used in the study
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants will wear each type of lens for 15 minutes to evaluate comfort

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Biomedics 1 Day Extra Sphere
  • Clariti 1 Day Sphere
Trial Overview The study compares two types of daily disposable soft contact lenses: Lens 1 (ocufilcon D) versus Lens 2 (somofilcon A). It aims to assess which lens performs better in terms of comfort, vision quality, and overall user experience.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Lens 2 (somofilcon A)Experimental Treatment1 Intervention
Group II: Lens 1 (ocufilcon D)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CooperVision International Limited (CVIL)

Lead Sponsor

Trials
171
Recruited
14,600+
Dr. Patrizia Cavazzoni profile image

Dr. Patrizia Cavazzoni

CooperVision International Limited (CVIL)

Chief Medical Officer

MD from Harvard Medical School

Steven Robins profile image

Steven Robins

CooperVision International Limited (CVIL)

President, Americas

Bachelor of Arts from Bates College, participated in Pfizer Global Leadership Program with Harvard University

Centre for Ocular Research & Education, Canada

Collaborator

Trials
14
Recruited
2,600+

Citations

Biomedics® 1 Day Extra (ocufilcon D) Soft Contact Lens1 Day Extra (ocufilcon D) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons ...
Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 ...The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best).
Clinical Performance of Habitual Wearers of Bioclear 1-day ...Open label, 1-week daily disposable, dispensing study Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ...
NEW Biomedics® 1 day Extra lensBiomedics 1 day Extra maintains the same fitting characteristics as Biomedics 1 day. - Push up. - Post blink movement. - Overall centration. - Comparable for ...
Soft Contact Lenses for Near-sightedness... Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere will have tolerable side effects & efficacy for patients with Near-sightedness and Near-sightedness ...
Biomedics® 1 day extraFor the device safety, warnings, precaution, and local regulatory information, please refer to the Instruction for use leaflet. * After 1 week of daily wear; ...
Ocular Sciences (ocufilcon D) soft (hydrophilic) contact lensThe lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The BIOMEDICS® UV Colors ...
Myopia (Disorder) (DBCOND0126788)Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere, No ... MiSight 1 Day Safety Post-Approval Study, No drug interventions, treatment ...
Biomedics 1 Day Extra - Pack of 30 - Daily Contact lensesSpherical lenses are designed to correct myopia and hyperopia. They have a uniform curvature that corrects vision equally in all directions, providing clear and ...
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