Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

Not Applicable

Completed

• Conditions: Ametropia
• Interventions: Device: Lens A (ocufilcon D); Device: Lens B (fanfilcon A)

• Registration Number: NCT06400914
• Lead Sponsor: CooperVision International Limited (CVIL)

Brief Summary

The aim of this study is to compare the short-term clinical performance of two sphere contact lenses.

Detailed Description

The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-02
• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-06
• Primary Completion: 2024-05-11
• Study Completion: 2024-05-11
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Is at least 18 years of age and has full legal capacity to volunteer.
2. Has read and signed an information consent letter.
3. Self-reports having a full eye examination in the previous two years.
4. Anticipates being able to wear the study lenses for the required time of the study.
5. Is willing and able to follow instructions and maintain the appointment schedule.
6. Has refractive astigmatism no higher than -0.75 DC.
7. Can be fit with the available lens parameters (sphere +6.00 to -10.00D).
8. Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

Exclusion Criteria

1. Is participating in any concurrent clinical or research study.
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear.
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study.
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
7. Has undergone refractive error surgery or intraocular surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens A (ocufilcon D)	Lens A (ocufilcon D)	All participants will wear lens A for 15 minutes (Period 1).
Lens B (fanfilcon A)	Lens B (fanfilcon A)	All participants will wear lens B for 15 minutes (Period 2).

Primary Outcome Measures

Name	Time	Method
Lens Fit Acceptance Ratings	15 Minutes	Overall lens fit acceptance will be measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)

Trial Locations

Locations (1)

Consultorio Optométrico Queretaro; 🇲🇽 Mexico City, Mexico