Contact Lenses for Astigmatism

No longer recruiting at 21 trial locations
SC
Overseen ByStudy Contact
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Johnson & Johnson Vision Care, Inc.
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 tests new daily disposable contact lenses for people with astigmatism, a condition where the eye's shape causes blurry vision. The study aims to determine the safety and effectiveness of these investigational daily disposable, soft, toric lenses by having participants wear them for a week, then switch to another lens type for comparison. It suits those who regularly wear soft contact lenses in both eyes and have specific astigmatism correction needs. Participants should also have glasses for distance vision. This trial is not suitable for individuals with certain eye conditions or those using ocular medications. As an unphased trial, it offers participants the chance to contribute to innovative research in vision care.

Will I have to stop taking my current medications?

If you are currently using any eye medications or have an eye infection, you cannot participate in the study. Also, if you have any disease or take medications that might interfere with wearing contact lenses, you may be excluded.

What prior data suggests that these contact lenses are safe for astigmatism?

Research has shown that daily disposable soft toric lenses are generally easy to wear. One study found these lenses to be very comfortable, with an average comfort score of 92 out of 100 during the day. Even at the end of the day, the comfort score remained high at about 82.5 out of 100, indicating that most people find them comfortable throughout the day.

Regarding safety, other studies have tested these lenses and found no major problems. Designed for daily use, they can lower the risk of infections compared to lenses worn for longer periods. Using a new pair each day helps maintain eye health.

Overall, these lenses appear safe and comfortable for most people. However, it is important to follow the instructions from an eye care provider on how to wear and care for them.12345

Why are researchers excited about this trial?

Researchers are excited about these investigational daily disposable, soft, toric lenses for astigmatism because they offer a fresh approach to comfort and convenience compared to traditional options like monthly or bi-weekly contact lenses. These lenses are designed for daily use, potentially reducing the risk of eye infections and eliminating the need for cleaning solutions. Additionally, the toric design specifically addresses the unique shape of the astigmatic eye, potentially improving vision clarity and stability. By focusing on both vision correction and wearer comfort, these lenses could set a new standard for astigmatism treatment.

What evidence suggests that these contact lenses are effective for astigmatism?

Research shows that modern soft toric lenses can greatly improve vision for people with astigmatism. Studies have found that these lenses provide clearer vision and more comfort than other options, especially with daily use. In this trial, participants will wear investigational daily disposable soft toric lenses and compare them to control lenses. Patients have rated the latest ACUVUE lenses higher for vision and comfort compared to some other brands. Additionally, people with astigmatism who had stopped using contact lenses reported clearer vision after switching to these advanced lenses. Overall, evidence supports that these lenses offer clear and comfortable vision for those with astigmatism.16789

Who Is on the Research Team?

J&

Johnson & Johnson Vision Care, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Vision Care, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with astigmatism who require corrective lenses. Participants should be interested in trying out new types of daily disposable toric soft contact lenses. Specific eligibility criteria are not provided, but typically participants must meet certain vision and eye health requirements.

Inclusion Criteria

Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
Possess a wearable pair of spectacles that provide correction for distance vision
Have best corrected monocular distance visual acuity of 20/30 or better in each eye
See 3 more

Exclusion Criteria

I have eye conditions that prevent me from wearing contact lenses.
I have had or will have eye surgery during the study.
Be currently pregnant or lactating
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the Test Lens followed by the Control Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods

4 weeks
Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks
Up to 3 visits

What Are the Treatments Tested in This Trial?

Interventions

  • Investigational daily disposable, soft, toric lenses
Trial Overview The study compares two types of daily disposable toric soft lenses for astigmatism: one made with a traditional process using isopropyl alcohol (ACUVUE® Oasys), and another made with a newer technology using propylene glycol. It's a controlled test where patients wear each type without knowing which is which.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Test/ControlExperimental Treatment2 Interventions
Group II: Control/TestExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johnson & Johnson Vision Care, Inc.

Lead Sponsor

Trials
224
Recruited
26,100+
Top Products
- ACUVUE® disposable contact lenses - TECNIS® intraocular lenses - LASIK vision correction systems
Joaquin Duato profile image

Joaquin Duato

Johnson & Johnson Vision Care, Inc.

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Johnson & Johnson Vision Care, Inc.

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

Evaluation of Daily Disposable Toric Soft Lenses ...This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and ...
Research highlights that the latest ACUVUE contact lens ...... OASYS MAX 1-Day for ASTIGMATISM outperformed Dailies Total1® for Astigmatism in patient reported outcomes related to vision and comfort.
Performance of a Toric, Monthly, Soft Contact Lens in ...Overall, the study contact lenses provided good performance when using a digital device for ≥ 8 hours. · Agree: 41.7% ; Overall, the study contact ...
Toric Contact Lenses: A Practice Growth OpportunityRecent studies suggest astigmatic patients who drop out of contact lens wear can have improved visual acuity when refit in a modern day soft ...
Prospective Evaluation of a Novel Multifocal Toric Daily ...This study evaluated the ability of a novel multifocal toric contact lens in a daily disposable lens with a single astigmatic lens power (−1.00D) ...
Summary of Safety and Effectiveness Data (SSED)The warnings and precautions can be found in the Precision7™, Precision7™ for. Astigmatism, Precision7™ Multifocal, Precision7™ Multifocal Toric ...
(PDF) Clinical Performance of a Novel Daily Disposable ...A previous study using the same lenses found a median (IQR) overall comfort score of 92.0 (18.00) and end of day comfort was 82.50 (51.25), 14 which was similar ...
Clinical Performance of Two Daily Disposable Toric Soft ...The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM ( ...
Real-Time Changes in the Comfort of a Toric, Monthly, Soft ...Conclusions. Results from the present work found that the comfort of a monthly, toric, soft CL slightly decreased over the long wearing day, ...
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