Contact Lenses for Astigmatism

Recruiting at 11 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: 4

Duration: 3 weeks

134 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using any eye medications or have any conditions or medications that might interfere with contact lens wear.

What data supports the effectiveness of the treatment Delefilcon A, Senofilcon A for astigmatism?

Research shows that Delefilcon A contact lenses provide comfort for people with astigmatism compared to other lenses, and Senofilcon A lenses are effective for protecting the eye and relieving pain. This suggests that these lenses can be effective for people with astigmatism by offering comfort and eye protection. ^{1 2 3 4 5}

Is it safe to use contact lenses like Delefilcon A and Senofilcon A for astigmatism?

Research shows that Senofilcon A contact lenses are used safely for therapeutic purposes, providing corneal protection and pain relief without significant complications. Delefilcon A lenses are also evaluated for comfort in astigmatism, suggesting they are generally safe for use. ^{1 2 3 6 7}

How do Delefilcon A and Senofilcon A contact lenses for astigmatism differ from other treatments?

Delefilcon A contact lenses are unique because they are daily disposable lenses specifically designed for astigmatism, offering improved comfort compared to weekly or monthly lenses. Senofilcon A lenses are notable for their use in therapeutic applications, providing corneal protection and pain relief, which is not a typical feature of standard contact lenses for astigmatism. ^{1 2 3 4 7}

What is the purpose of this trial?

This is a prospective, multi-site, 4-visit, bilateral, dispensing, randomized, controlled, double-masked, 2x2 crossover study to evaluate subjective comfort, overall opinion and end of day comfort following wear of two different contact lenses.

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 are interested in trying out two different brands of daily disposable toric soft contact lenses. Specific eligibility details were not provided, so general criteria such as age, health status, and previous contact lens experience may apply.

Inclusion Criteria

Have best corrected monocular distance visual acuity of 20/25 or better in each eye

Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form

Appear able and willing to adhere to the instructions set forth in this clinical protocol

Exclusion Criteria

Be currently wearing monovision or multifocal contact lenses

Be currently wearing lenses in an extended wear modality

My vision changes because of severe dry eye or other eye problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear each study lens (Control lens and Test lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods

3 weeks

4 visits (in-person)

Follow-up

Participants are monitored for comfort, overall opinion, and end of day comfort following lens wear

1 week

Treatment Details

Interventions

• Delefilcon A
• Senofilcon A

Trial Overview The study is testing the comfort levels of Delefilcon A (test lens) versus Senofilcon A (control lens) contact lenses over a week. Participants will wear each type of lens during separate periods to compare subjective comfort and overall satisfaction.

Participant Groups

Group I: Test/Control Experimental Treatment 2 Interventions

Eligible subjects will be randomized into the Test/Control sequence, to wear each study lens (Test lens and Control lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.

Group II: Control/Test Experimental Treatment 2 Interventions

Eligible subjects will be randomized into the Control/Test sequence, to wear each study lens (Control lens and Test lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens 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

Findings from Research

In a study of 43 patients using senofilcon A contact lenses for therapeutic purposes, 81% of those fitted for pain relief reported full effectiveness, indicating strong efficacy in managing corneal pain.

The lenses also showed a 64% full effectiveness rate in improving corneal integrity, with no reported adverse events, highlighting their safety and effectiveness in protecting the cornea post-surgery and during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of senofilcon a contact lenses for therapeutic bandage lens indications. Shafran, T., Gleason, W., Osborn Lorenz, K., et al.[2022]

In a study of 85 symptomatic wearers of reusable toric contact lenses, switching to delefilcon A daily disposable lenses significantly improved comfort, with a notable reduction in dry eye symptoms as measured by the CLDEQ-8 questionnaire.

After 2 weeks of wearing delefilcon A lenses, 78.9% of participants reported little to no eye discomfort, compared to only 51.7% with their previous lenses, indicating a clear advantage in comfort and dryness relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comfort After Refitting Symptomatic Habitual Reusable Toric Lens Wearers with a New Daily Disposable Contact Lens for Astigmatism. Wan, K., Mashouf, J., Hall, B.[2023]

After two weeks of daily wear of senofilcon A contact lenses, there were no significant changes in visual acuity or overall ocular surface health in 17 participants, indicating that short-term use may be safe.

However, the study found a significant decrease in tear film stability and MUC5AC mRNA expression, along with an increase in tear interleukin-6 levels, suggesting potential inflammatory responses and tear instability associated with contact lens wear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of 2 week senofilcon-A silicone hydrogel contact lens daily wear on tear functions and ocular surface health status. Dogru, M., Ward, SK., Wakamatsu, T., et al.[2011]

In a study involving 183 presbyopic subjects, a modified fitting guide for multifocal contact lenses significantly reduced the number of lenses needed for a successful fit compared to the previous guide, with an average of 1.2 lenses versus 1.4 lenses required.

The modified guide also resulted in a higher success rate, with 82.8% of eyes fitted with one pair of lenses, compared to 65.1% with the previous guide, indicating improved efficacy in fitting multifocal lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing a modified fitting approach for improved multifocal contact lens fitting. Merchea, M., Evans, D., Kannarr, S., et al.[2020]

The senofilcon A contact lens with a new manufacturing technique showed a significantly increased probability of longer vision break-up time (VBUT) compared to the control lens, indicating better stability of the tear film.

The study, involving 50 healthy adult participants, demonstrated that the test lens also outperformed the control lens in terms of modulation transfer function (MTF) cutoff, suggesting improved optical performance without any serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tear film dynamics of a new soft contact lens. Buch, J., Riederer, D., Scales, C., et al.[2023]

In a study involving adults aged 18 to 45 who use digital devices for at least 3 hours daily, samfilcon A contact lenses received high satisfaction ratings for comfort, vision, and overall performance, indicating they are a suitable option for myopic users.

Patients who previously wore senofilcon A or lotrafilcon B lenses reported significantly better experiences with samfilcon A lenses, suggesting an improvement in comfort and visual quality, with favorable assessments from investigators as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Performance of Samfilcon A Contact Lenses in Intensive Digital Device Users: A Multicenter, Prospective Clinical Study. Uçakhan, ÖÖ., Taşındı, E., Toker, E., et al.[2021]

In a study involving 1,253 patients, 96% reported good to excellent satisfaction with the novel toric nesofilcon A contact lens, indicating high comfort and vision performance.

There was no significant difference in satisfaction levels between habitual contact lens wearers and nonwearers, suggesting that the lens is effective for all types of users, including those new to contact lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction of astigmatic patients with toric nesofilcon A contact lenses. Saxon, J., Rah, MJ., Reindel, WT.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Application of senofilcon a contact lenses for therapeutic bandage lens indications. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Comfort After Refitting Symptomatic Habitual Reusable Toric Lens Wearers with a New Daily Disposable Contact Lens for Astigmatism. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The effects of 2 week senofilcon-A silicone hydrogel contact lens daily wear on tear functions and ocular surface health status. [2011]

4. England pubmed.ncbi.nlm.nih.gov

Assessing a modified fitting approach for improved multifocal contact lens fitting. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Tear film dynamics of a new soft contact lens. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Clinical Performance of Samfilcon A Contact Lenses in Intensive Digital Device Users: A Multicenter, Prospective Clinical Study. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Satisfaction of astigmatic patients with toric nesofilcon A contact lenses. [2022]