Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

NCT06400914 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-156
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ametropia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lens A (ocufilcon D)

EXPERIMENTAL

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

Device: Lens A (ocufilcon D)

Lens B (fanfilcon A)

EXPERIMENTAL

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

Device: Lens B (fanfilcon A)

Interventions

Lens A (ocufilcon D) DEVICE

15 minutes of daily wear.

Lens A (ocufilcon D)

Lens B (fanfilcon A) DEVICE

15 minutes of daily wear.

Lens B (fanfilcon A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CooperVision, Inc.: lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (1)

Consultorio Optométrico Queretaro

Mexico City, 06760, Mexico

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, OD, MSc, FAAO
• Organization: CooperVision, Inc.

javega@coopervision.com

925-621-3761

Study Officials

• Ruben Guerrero, MSc, FIACLE

  National Autonomous University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 6, 2024
• Study Start: April 3, 2024
• Primary Completion: May 11, 2024
• Study Completion: May 11, 2024
• Last Updated: August 15, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-08

Locations

ME (1)