Soft Contact Lenses for Near-sightedness

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CooperVision International Limited (CVIL)

Must not be taking: Systemic medications

Disqualifiers: Ocular disease, Systemic condition, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to evaluate and compare the performance of two soft contact lenses.

Research Team

Lyndon Jones, PhD FCOptom

Principal Investigator

Centre for Ocular Research and Education

Eligibility Criteria

This trial is for adults over 18 who already use soft contact lenses and have mild to moderate near-sightedness, with prescriptions between -1.00DS to -6.00DS and astigmatism up to -1.00DC in each eye. Participants must be able to see clearly with the study lenses and keep scheduled appointments.

Inclusion Criteria

Have understood and signed an information consent letter

Are willing and able to maintain the appointment schedule

Are an adapted soft contact lens wearer

Exclusion Criteria

Are participating in any concurrent clinical or research study

Have a systemic condition that would contraindicate contact lens use

Have known sensitivity to the diagnostic fluorescein sodium to be used in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants will wear each type of lens for 15 minutes to evaluate comfort

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Biomedics 1 Day Extra Sphere
• Clariti 1 Day Sphere

Trial Overview The study compares two types of daily disposable soft contact lenses: Lens 1 (ocufilcon D) versus Lens 2 (somofilcon A). It aims to assess which lens performs better in terms of comfort, vision quality, and overall user experience.

Participant Groups

Group I: Lens 2 (somofilcon A) Experimental Treatment 1 Intervention

All participants will wear lens 2 for 15 minutes (Period 2).

Group II: Lens 1 (ocufilcon D) Experimental Treatment 1 Intervention

All participants will wear lens 1 for 15 minutes (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+