Contact Lenses for Astigmatism

Overseen By Percy Lazon, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: CooperVision International Limited (CVIL)

Must not be taking: Systemic medications

Disqualifiers: Ocular disease, Allergies, Surgery, others

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

Compensation: Varies

Number of Visits: 9

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to evaluate and compare the performance of two soft contact lens.

Research Team

Lyndon Jones, PhD,FCOptom

Principal Investigator

Centre for Ocular Research and Education

Eligibility Criteria

This trial is for individuals with low astigmatism and may also have near-sightedness or farsightedness. Specific eligibility criteria are not provided, but typically participants must meet certain vision and eye health requirements.

Inclusion Criteria

Have specific astigmatism values in each eye

Achieves specific visual acuity in each eye

Fit with available study contact lens powers

Exclusion Criteria

Employee of the Centre for Ocular Research & Education directly involved in the study

Participating in any concurrent clinical interventional study

Worn rigid contact lenses in the last 3 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment - Period 1

Participants wear Control Contact Lens (stenfilcon A Sphere) for one week

1 week

Day 1 (in-person), Day 7 (in-person)

Treatment - Period 2

Participants wear Test Contact Lens (stenfilcon A Toric) for one week

1 week

Day 8 (in-person), Day 13 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• stenfilcon A Sphere
• stenfilcon A Toric

Trial Overview The study aims to compare the performance of two types of soft contact lenses: a control lens (stenfilcon A Sphere) for standard vision correction, and a test lens (stenfilcon A Toric) designed specifically for astigmatism.

Participant Groups

Group I: Test Contact Lens (stenfilcon A Toric) Experimental Treatment 1 Intervention

All participants will wear Test Contact Lens for one week (Period 2).

Group II: Control Contact Lens (stenfilcon A Sphere) Experimental Treatment 1 Intervention

All participants will wear Control Contact Lens for one week (Period 1).

Who Is Running the Clinical Trial?

CooperVision International Limited (CVIL)

Lead Sponsor

Trials

171

Recruited

14,600+

Dr. Patrizia Cavazzoni

CooperVision International Limited (CVIL)

Chief Medical Officer

MD from Harvard Medical School

Steven Robins

CooperVision International Limited (CVIL)

President, Americas

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

Centre for Ocular Research & Education, Canada

Collaborator

Trials

14

Recruited

2,600+