Contact Lenses for Astigmatism

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of contact lenses, Delefilcon A and Senofilcon A, to determine which provides more comfort throughout the day for people with astigmatism, a common vision condition that causes blurriness. Participants will wear each lens for a week, with a break in between, to compare comfort levels. It is ideal for those who frequently wear soft contact lenses and have astigmatism that fits a specific lens prescription. As an unphased trial, this study offers a unique opportunity to directly compare the comfort of two popular lenses for astigmatism.

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

Research shows that both Delefilcon A and Senofilcon A contact lenses provide comfort for users. Studies have found that Delefilcon A lenses offer excellent comfort and help reduce dryness. Notably, 91% of users reported greater comfort than expected, and 98% found them easy to use.

Senofilcon A lenses also enjoy a good reputation. Safety data indicates that these lenses provide clear and stable vision, even with head or eye movement. They are designed to protect against harmful UV rays, enhancing safety.

Both types of lenses have FDA approval for vision correction and are commonly used for astigmatism, a condition that causes blurred vision. This approval ensures their safety for users. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional contact lenses for astigmatism, which typically rely on hydrogel materials, the treatments Delefilcon A and Senofilcon A use advanced silicone hydrogel materials. These materials allow more oxygen to reach the eye, which can enhance comfort and eye health. Researchers are excited about these treatments because they are designed for daily disposable use, potentially offering better hygiene and convenience compared to reusable lenses. Additionally, their unique material composition could improve vision clarity and wearer satisfaction.

What evidence suggests that this trial's treatments could be effective for astigmatism?

This trial will compare Delefilcon A and Senofilcon A contact lenses for astigmatism. Studies have shown that Delefilcon A lenses effectively provide comfort and reduce dryness. In one study, 91% of users found these lenses more comfortable than expected. Another study demonstrated that Delefilcon A lenses were more comfortable and could be worn longer than other lenses. Senofilcon A lenses, meanwhile, are known for correcting vision problems related to aging, such as difficulty seeing up close. They also remain comfortable for extended periods, such as during eight or more hours of digital device use. Both types of lenses have improved wearer satisfaction and comfort. Participants in this trial will experience both lenses in different sequences to assess their effectiveness and comfort. ^{3 5 6 7 8}

Who Is on the Research Team?

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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

Dr. Jijo James, MD

Johnson & Johnson Vision Care, Inc.

Chief Medical Officer since 2014

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

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988191/

Patient Satisfaction with a Novel Daily Toric Contact Lens ... The results suggest that Dailies Total1 for Astigmatism contact lenses offer favorable comfort and vision for individuals who had previously been dissatisfied ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1367048417301091

Performance evaluation of delefilcon a water gradient daily ... Ninety-one percent of subjects reported that their study lenses were more comfortable than expected, 98% agreed that they were convenient to use, and 92% were ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06749496

Study Details | NCT06749496 | Evaluation of Delefilcon A ... This is a prospective, multi-site, 4-visit, bilateral, dispensing, randomized, controlled, double-masked, 2x2 crossover study to evaluate subjective comfort ...

4. researchgate.net researchgate.net/publication/393912450_A_Clinical_Study_Evaluating_How_Delefilcon_A_Contact_Lenses_Perform_in_Satisfied_Senofilcon_A_Contact_Lens_Wearers

A Clinical Study Evaluating How Delefilcon A Contact ... This study found that most subjects were able to remain satisfied CL wearers and had a positive CL wearing experience after switching CL brands.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11512522/

Investigation of Delefilcon A Contact Lenses for Symptomatic ... This study demonstrated that DT1 lenses offered superior comfort, reduced dryness symptoms, and extended comfortable wear time compared to ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/K113168.pdf

11460 Johns Creek Parkway - accessdata.fda.gov DAILIES TOTAL1® for Astigmatism (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia ...

7. us.alconscience.com us.alconscience.com/sites/g/files/rbvwei1736/files/pdf/DAILIES-TOTAL1-Delefilcon-A-Daily-Disposable-Contact-Lenses_p-US-DT1-2000031.pdf

DAILIES TOTAL1 (Delefilcon A) Daily Disposable Contact ... DAILIES TOTAL1 are daily disposable contact lenses (delefilcon A) designed and manufactured with rigorous research and clinical studies.

8. myalcon.com myalcon.com/professional/contact-lenses/

Discover Alcon Contact Lenses & Solutions - MyAlcon PRECISION7® FOR ASTIGMATISM. PRECISION7® is the only one-week toric lens that offers 16 hours of outstanding comfort and precise vision even at day 715.