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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-24

Study Completion Date

2025-02-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lens 1 (ocufilcon D)

All participants will wear lens 1 for 15 minutes (Period 1).

Group Type EXPERIMENTAL

Lens 1 (ocufilcon D)

Intervention Type DEVICE

15 minutes of daily wear

Lens 2 (somofilcon A)

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

Group Type EXPERIMENTAL

Lens 2 (somofilcon A)

Intervention Type DEVICE

15 minutes of daily wear

Interventions

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Lens 1 (ocufilcon D)

15 minutes of daily wear

Intervention Type DEVICE

Lens 2 (somofilcon A)

15 minutes of daily wear

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No