Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

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

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: Lens A (ocufilcon D); Device: Lens B (fanfilcon A)

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06760
    • Consultorio Optométrico Queretaro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A (ocufilcon D); All participants will wear lens A for 15 minutes (Period 1).	Device: Lens A (ocufilcon D); 15 minutes of daily wear.
Experimental: Lens B (fanfilcon A); All participants will wear lens B for 15 minutes (Period 2).	Device: Lens B (fanfilcon A); 15 minutes of daily wear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Fit Acceptance Ratings	Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)	At the end of 15 Minutes of wear

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Collaborators: Centre for Ocular Research & Education, Canada
• Investigators: Principal Investigator: Ruben Guerrero, MSc, FIACLE, National Autonomous University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): May 11, 2024
• Study Completion (Actual): May 11, 2024

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: EX-MKTG-156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes