Delefilcon A Contact Lenses for Refractive Errors

Recruiting at 11 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

190 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.

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 data supports the effectiveness of the treatment Delefilcon A Contact Lenses for refractive errors?

Research suggests that Delefilcon A contact lenses, which use water gradient technology, may improve tear film dynamics, potentially enhancing comfort and wearability for users. This could indirectly support their effectiveness in correcting refractive errors by maintaining a stable and comfortable lens fit. ^{1 2 3 4 5}

Is Delefilcon A safe for use in humans?

Research on Delefilcon A contact lenses, specifically for astigmatism, suggests they are generally safe and comfortable for wearers. No significant safety concerns were reported in studies comparing them to other types of contact lenses. ^{2 6 7 8 9}

How is Delefilcon A Contact Lenses treatment different from other treatments for refractive errors?

Delefilcon A Contact Lenses are unique because they use water gradient technology, which helps maintain moisture and comfort by improving tear film dynamics, making them more comfortable for prolonged wear compared to other contact lenses. ^{1 5 6 10 11}

Research Team

Principal Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Non-invasive pre-lens tear film assessment with high-speed videokeratoscopy. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Six months of in-practice experience with a high Dk lotrafilcon a soft contact lens. [2019]

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

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

4. India pubmed.ncbi.nlm.nih.gov

Tear Deformation Time and optical quality in eyes wearing silicone hydrogel contact lenses. [2020]

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

Role of the Water Gradient Structure in Inhibiting Thin Aqueous Layer Break in Silicone Hydrogel-Soft Contact Lens. [2021]

6. 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]

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

Three-year follow-up of biomicroscopy signs and refractive status in patients wearing lotrafilcon A lenses. [2019]

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

Dexamethasone-Eluting Contact Lens for the Prevention of Postphotorefractive Keratectomy Scar in a New Zealand White Rabbit Model. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The impact of lens choice in the relief of contact lens related symptoms and ocular surface findings. [2017]

10. Iran pubmed.ncbi.nlm.nih.gov

Comparative Study of Two Silicone Hydrogel Contact Lenses used as Bandage Contact Lenses after Photorefractive Keratectomy. [2021]

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

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