Toric Contact Lenses for Astigmatism

JV
Overseen ByJose Vega, O.D., MSc., PhD, FAAO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CooperVision International Limited (CVIL)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe the effects of switching from one type of toric contact lens to another. It focuses on the effectiveness of a new lens, Fanfilcon A, for individuals with astigmatism, a common vision issue that causes blurry vision. The study will last one month and will assess both the comfort of the new lenses and their impact on vision. This trial may suit those who currently wear Biofinity toric lenses with specific vision prescriptions and can wear lenses for most of the day, nearly every day. As an unphased trial, it offers a unique opportunity to explore new lens options and enhance vision comfort.

What prior data suggests that the Fanfilcon A Toric Contact Lens is safe for astigmatism?

Research has shown that toric contact lenses, including the Fanfilcon A Toric Contact Lens, generally provide comfort for users. One study on similar lenses found that 93.72% of individuals with high astigmatism reported satisfactory performance. This suggests these lenses are safe for most people with astigmatism.

While specific safety details for Fanfilcon A are not provided, toric lenses are typically safe when used correctly. Users should adhere to standard contact lens care, such as maintaining cleanliness, to prevent issues like eye irritation.12345

Why are researchers excited about this trial?

The Fanfilcon A Toric Contact Lens is unique because it offers a fresh approach to correcting astigmatism compared to current soft toric lenses like Confilcon A. One of its standout features is the improved material composition, which enhances oxygen permeability, potentially offering more comfort and healthier eyes for wearers. Researchers are excited about Fanfilcon A because it could provide better lens stability and visual acuity, leading to a more satisfying experience for those with astigmatism.

What evidence suggests that the Fanfilcon A Toric Contact Lens is effective for astigmatism?

Research has shown that Fanfilcon A Toric Contact Lenses, which participants in this trial will be refitted to, can improve near vision for people with astigmatism. Studies have found that these lenses enhance vision clarity in both bright and dim lighting by about half to one line on an eye chart. Most users report clear vision throughout the day, with 85% noting the lenses remain clear and 71% still satisfied by day's end. These toric lenses are specially designed to correct astigmatism, which can cause blurry vision and eye strain. Overall, evidence supports that Fanfilcon A Toric Contact Lenses effectively provide clear vision and comfort for those with astigmatism.46789

Are You a Good Fit for This Trial?

This trial is for people who have astigmatism (with or without nearsightedness) and are currently wearing toric soft contact lenses. Participants must be willing to switch to a new type of toric lens for one month.

Inclusion Criteria

I am at least 18 years old.
Understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent
I can see at least 20/25 in each eye with contact lenses.
See 6 more

Exclusion Criteria

I have blood vessels deeper than 1 mm in my cornea that are not active.
Slit lamp findings that are more serious than grade 1 (ISO scale)
I have an infection, inflammation, or abnormality in the front part of my eye.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are refitted from Comfilcon A to Fanfilcon A toric contact lenses and wear them daily for one month

4 weeks
Baseline, 1 week, and 1 month visits

Follow-up

Participants are monitored for subjective comfort and clinical outcomes after the transition

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fanfilcon A Toric Contact Lens

Trial Overview

The study looks at how well people do after switching from their current toric soft contact lenses to Fanfilcon A Toric contact lenses, focusing on comfort, vision quality, and overall satisfaction over one month.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Refit to Fanfilcon A Toric Contact LensExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CooperVision International Limited (CVIL)

Lead Sponsor

Trials
171
Recruited
14,600+
Dr. Patrizia Cavazzoni profile image

Dr. Patrizia Cavazzoni

CooperVision International Limited (CVIL)

Chief Medical Officer

MD from Harvard Medical School

Steven Robins profile image

Steven Robins

CooperVision International Limited (CVIL)

President, Americas

Bachelor of Arts from Bates College, participated in Pfizer Global Leadership Program with Harvard University

Citations

Toric Contact Lenses Enhance Near Vision Performance

Results indicated that toric lenses enhanced near high- and low-contrast visual acuity by 0.5 to 1 line, improved reading speed, and reduced ...

Clinical Performance of Biofinity Toric Versus Air Optix for ...

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) ...

An International Survey of Toric Contact Lens Prescribing

Results: Data were collected in relation to 21,150 toric fits (25%) and 62,150 spherical fits (75%). Toric prescribing ranged from 6% of lenses in Russia to 48% ...

Toric contact lenses, Part 1: Toric fitting trends

This this first part of a 3-part series, we examine current fitting practices for low astigmats, both globally and in the US market.

Performance of Toric Silicone Hydrogel Contact Lenses

Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) orbetter in each eye. Can achieve a distance visual acuity of ...

Latest CORE Publication Offers Soft Toric Contact Lens ...

Her clinical insight presents a case report illustrating the ineffectiveness of spherical lenses in correcting corneal astigmatism, emphasizing ...

Comparison of Comfilcon A Toric Contact... | Clinical Trial

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

NCT07557030 | Optimization for Toric Contact Lenses

They involve very limited human exposure to the drug. There are three types of violations: Failure to submit required clinical trial information Submission of ...

MAKING THE MOST OF THE SOFT TORIC CONTACT ...

Uncorrected astigmatism not only results in reduced visual performance for the wearer but can ultimately lead to contact lens dropout. Sub-optimal vision ...