Contact Lenses for Astigmatism

Recruiting at 19 trial locations

Overseen By Study Contact

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Vision Care, Inc.

Must not be taking: Ocular medications

Disqualifiers: Pregnancy, Diabetes, Ocular disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

282 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.

Research Team

Johnson & Johnson Vision Care, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Vision Care, Inc.

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Test/Control Experimental Treatment 2 Interventions

Eligible subjects will be randomized to the Test/Control sequence, to 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.

Group II: Control/Test Experimental Treatment 2 Interventions

Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens followed by the Test Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.

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

Johnson & Johnson Vision Care, Inc.

Chief Executive Officer since 2022

Master’s from Thunderbird School of Global Management, MBA from ESADE

Dr. Raj Rajpal

Johnson & Johnson Vision Care, Inc.

Chief Medical Officer since 2023

MD