Delefilcon A Contact Lenses for Refractive Errors

No longer recruiting at 15 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Anterior segment disease, Refractive surgery, Irregular cornea, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well delefilcon A contact lenses fit when available in various shapes and sizes. The goal is to determine if altering the base curves and diameters affects comfort and vision for individuals with refractive errors (vision problems requiring glasses or contacts). Participants will try two different types of these lenses, switching after a short break. Those who currently wear soft contact lenses regularly, have a prescription between -2.00 and -4.00 diopters, and achieve good vision with their current glasses are suitable for this study. As an unphased trial, this study allows participants to contribute to advancements in contact lens comfort and vision correction.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

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

Research on Delefilcon A contact lenses shows they are generally safe and comfortable for wearers. In studies, most people found them comfortable all day and reported clear vision. About 91% of users found the lenses more comfortable than expected. Importantly, no major safety issues have been reported. While some might experience minor discomfort, serious problems are rare. These lenses already correct vision problems like nearsightedness and farsightedness, supporting their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Delefilcon A contact lenses for refractive errors because they offer a novel approach to correcting vision with their unique design features. Unlike standard contact lenses, which typically have uniform base curves and diameters, these lenses are being tested with different base curves and diameters tailored to individual needs, potentially offering a more customized fit and comfort. This customization could lead to improved vision correction and wearing experience. Moreover, the lenses are designed for shorter wear periods, reducing the time commitment while still providing effective vision correction.

What evidence suggests that delefilcon A contact lenses are effective for refractive errors?

Research has shown that Delefilcon A contact lenses are very comfortable and easy to use. In one study, 91% of participants found these lenses more comfortable than expected, and 98% reported they were simple to use. Another study found these lenses more comfortable and less drying, allowing for longer wear compared to other lenses. Most users reported a positive experience when switching to Delefilcon A lenses and expressed satisfaction with their choice. This trial will evaluate two different sequences of wearing Delefilcon A lenses with varying base curves and diameters. These findings suggest that Delefilcon A lenses effectively provide comfort and convenience for those needing vision correction. ^{3 4 6 7 8}

Who Is on the Research Team?

Principal Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with refractive errors, such as near-sightedness. Specific eligibility criteria are not provided, but typically participants would need to have a stable prescription and no eye diseases.

Inclusion Criteria

Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D)

Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months

Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR) in each eye

Exclusion Criteria

I don't have eye infections or conditions that prevent wearing contact lenses.

I have had or plan to have eye surgery to correct my vision, or I have an irregular cornea.

My eye exam showed moderate to severe surface eye changes or some blood vessel growth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment Period 1

Participants wear delefilcon A contact lenses with different base curves and diameters for 6 (+2) hours

1 day

1 visit (in-person)

Washout

A one-to-two day washout period between lens wear periods

1-2 days

Treatment Period 2

Participants wear delefilcon A contact lenses with standard base curves and diameters for 6 (+2) hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for lens fit and centration at 6-hour follow-up

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Delefilcon A Contact Lenses

Trial Overview The study is testing Delefilcon A contact lenses. It compares lenses with various base curves and diameters to standard ones, assessing how well they fit.

How Is the Trial Designed?

Group I: LID023681, then LID006961 Experimental Treatment 2 Interventions

Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.

Group II: LID006961, then LID023681 Experimental Treatment 2 Interventions

Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

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 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 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]

Citations

1. 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 ...

2. withpower.com withpower.com/trial/phase-refractive-errors-3-2025-4555a

Delefilcon A Contact Lenses for Refractive Errors In a study of 43 patients using senofilcon A contact lenses for therapeutic purposes, 81% of those fitted for pain relief reported full effectiveness, ...

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06749496

Study Details | NCT06749496 | Evaluation of Delefilcon A ... In both eyes, have refractive error suitable for correction with the range of toric contact lens powers available in this study: 6.1 Sphere powers (DS) ...

5. 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.

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

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12306556/

Performance of Delefilcon A Daily Disposable Contact ... Most agreed the CL performed well, providing good comfort (91%) and vision all-day-long (94%), and did not have dryness with device use (69%).

8. 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.