250 Participants Needed

Contact Lenses for Vision Correction

JA
Overseen ByJose A Vega, OD,MSc,PhD
Age: 18 - 65
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 tests various contact lenses to evaluate their performance and comfort for wearers. Participants will try several types, including those with special features like blue light technology. It suits individuals who already wear soft contact lenses and have prescriptions ranging from -6.00 to +6.00. As an unphased trial, it allows participants to explore innovative contact lens technologies and contribute to advancements in eye care.

Will I have to stop taking my current medications?

The trial excludes people using medications that would interfere with wearing contact lenses, so you might need to stop certain medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the contact lenses under study have varied safety profiles. The comfilcon A lens, approved for up to 7 days of continuous wear, is generally well-tolerated. The delefilcon A lens is known for comfort, with some studies noting long periods of comfortable wear. Fanfilcon A lenses have a few reported issues, such as eye redness, but these are uncommon.

Kalifilcon A lenses are safe and effective for daily wear. Lehfilcon A lenses have a low risk of side effects and retain moisture, enhancing comfort. Samfilcon A lenses are approved and widely used, demonstrating a strong safety record.

Senofilcon A lenses, available in bi-weekly and daily disposable options, offer UV protection and are known for their safety. Daily disposables have a lower risk of certain eye infections. The version with blue light technology provides additional protection against blue-violet light. Serafilcon A lenses are also safe for correcting vision problems like nearsightedness.

Somofilcon A lenses have some reports of irritation but are generally safe for daily use. Stenfilcon A lenses are mostly safe, though some reports of side effects exist. Lastly, the verofilcon A lens is noted for comfort and maintaining good vision, with few safety concerns reported in studies.

These lenses have been in use for some time, and while each has specific characteristics, they generally show a trend of being safe and well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about these contact lenses because they offer a variety of features aimed at improving vision correction. Unlike traditional lenses, some of these investigational lenses incorporate blue light technology, which could help reduce eye strain from digital screens. Moreover, with options ranging from daily disposables to bi-weekly replacements, these lenses provide flexibility and convenience for different user preferences. Each lens type is designed to maximize comfort and clarity, potentially setting a new standard for contact lens wearers.

What evidence suggests that this trial's contact lenses could be effective for vision correction?

This trial will evaluate thirteen types of contact lenses for vision correction. Research has shown that the comfilcon A lens fits well in 94.6% of cases, providing clear vision. Delefilcon A lenses are known for comfort, with 91% of users finding them more comfortable than expected. Studies indicate that fanfilcon A lenses offer excellent vision quality, even at night. Kalifilcon A lenses provide stable vision at various distances. Lehfilcon A lenses are praised for comfort and sharp vision. Samfilcon A lenses perform well in both comfort and vision compared to others. Senofilcon A lenses, with blue light technology, enhance vision outdoors and in changing light. Serafilcon A lenses effectively correct common vision issues like nearsightedness and farsightedness. Somofilcon A lenses are highly rated for both vision quality and comfort. Stenfilcon A lenses offer strong sharpness of vision, achieving clear sight for most users. Finally, verofilcon A lenses are highly rated for comfort and dryness, maintaining performance throughout the day. Participants in this trial will wear these lenses in a randomized order to assess their performance.678910

Who Is on the Research Team?

PK

Pete Kollbaum, OD, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for individuals with vision issues like farsightedness or near-sightedness. Participants should be interested in trying out different types of contact lenses to assess their performance and comfort.

Inclusion Criteria

Refractive error of -6.00 to -0.50DS or +0.50 to +6.00DS and less than or equal to 0.75DC as vertexed to the corneal plane
Anisometropia no greater than 1.50D, based on vertexed manifest refraction spherical equivalent
Can achieve visual acuity of at least 20/25 in each eye with spherical equivalent manifest refraction
See 2 more

Exclusion Criteria

Used gas permeable/hard contact lenses (including orthokeratology) in the previous 3 months
Participation in a contact lens or lens care product trial in the previous 30 days
I am not on any medication that prevents me from wearing contact lenses.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types

13 weeks
13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • comfilcon A lens
  • delefilcon A lens
  • fanfilcon A lens
  • kalilfilcon A lens
  • lehfilcon A lens
  • samfilcon A lens
  • senofilcon A bi-weekly lens
  • senofilcon A daily disposable lens
  • senofilcon A with blue light technology lens
  • serafilcon A lens
  • somofilcon A lens
  • stenfilcon A lens
  • verofilcon A lens

Trial Overview

The study is testing various contact lenses made from materials like stenfilcon A, fanfilcon A, and others. It aims to compare how these lenses perform in terms of vision correction and user acceptance over a set period.

How Is the Trial Designed?

13

Treatment groups

Experimental Treatment

Group I: verofilcon A lensExperimental Treatment1 Intervention
Group II: stenfilcon A lensExperimental Treatment1 Intervention
Group III: somofilcon A lensExperimental Treatment1 Intervention
Group IV: serafilcon A lensExperimental Treatment1 Intervention
Group V: senofilcon A lens with blue light technologyExperimental Treatment1 Intervention
Group VI: senofilcon A lens daily disposableExperimental Treatment1 Intervention
Group VII: senofilcon A lens bi-weekly replacementExperimental Treatment1 Intervention
Group VIII: samfilcon A lensExperimental Treatment1 Intervention
Group IX: lehfilcon A lensExperimental Treatment1 Intervention
Group X: kalifilcon A lensExperimental Treatment1 Intervention
Group XI: fanfilcon A lensExperimental Treatment1 Intervention
Group XII: delefilcon A lensExperimental Treatment1 Intervention
Group XIII: comfilcon A 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

Wear Experiences with Two Soft Contact Lenses for ...

The results of this study show that wear experience with delefilcon A lenses for astigmatism can meet or exceed that of comfilcon A toric lenses.

P080011 BIOFINITY® (comfilcon A) Soft Contact Lens for ...

The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. BIOFINITY® (comfilcon A) Toric ...

Subjective Wearing Experience of Lehfilcon A Among ...

In conclusion, a high proportion of subjects were satisfied with the subjective wearing experience with lehfilcon A toric lenses after one month ...

A Clinical Study of the Comfilcon A Asphere Soft Contact ...

The aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon A asphere contact lens when compared to single- ...

Safety and Efficacy of a New Water Gradient Biomimetic ...

Lens position at month 3 was assessed as having optimal centration for 94.6% of the eyes with comfilcon A and 98.7% with lehfilcon A lenses.

BIOFINITY (comfilcon A) BIOFINITYToric ... - accessdata.fda.gov

The BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous ...

7.

coopervision.com

coopervision.com/safety

Important Safety Information for Daily Disposables

Only use fresh multi-purpose solution so you do not contaminate your lenses or lens case. Use of non-sterile solution can lead to severe infection, vision loss, ...

SUMMARY OF SAFETY AND EFFECTIVENESS (SSED)

The warnings and precautions can be found in the BIOFINITY® (comfilcon A) Soft. Contact Lens package insert labeling (attached). V. DEVICE ...

protocol title: - clinical evaluation of comfilcon a contact ...

Additionally, the contact lens should not be used if there is an active ocular inflammation, any eye disease or systemic disease that may ...

Contact lens safety and performance study

Comfilcon A contact lenses are CE- marked for both daily and overnight wear of up to 7 days for use by children and adults.