Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere

Not Applicable

Active, not recruiting

• Conditions: Myopia

• Registration Number: NCT06817785
• Lead Sponsor: CooperVision International Limited (CVIL)

Brief Summary

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

Detailed Description

The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing myopic soft lens wearers.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-24
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-02-21
• Study Completion: 2025-02-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Are at least 18 years of age and have full legal capacity to volunteer;
2. Have understood and signed an information consent letter;
3. Are willing and able to maintain the appointment schedule;
4. Are an adapted soft contact lens wearer;
5. Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
6. Have a refraction with a cylinder component of no more than -1.00DC in each eye;
7. Can be fitted with and achieve a distance visual acuity of +0.10 logMAR or better in each eye with the study contact lenses.

Exclusion Criteria

1. Are participating in any concurrent clinical or research study;
2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use;
3. Have a systemic condition that would contraindicate contact lens use;
4. Are using any systemic or topical medications that would contraindicate contact lens use;
5. Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
6. Are an employee of the Centre for Ocular Research & Education directly involved in the study (i.e. on the delegation log).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Lens Comfort	Immediately after lens application	The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best).

Trial Locations

Locations (1)

School of Optometry and Vision Science; 🇨🇦 Waterloo, Ontario, Canada