Clinical Evaluation of Two Toric Soft Contact Lenses

Clinical Evaluation of Biomedics Monthly Toric and Avaira Vitality Toric

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• 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 toric contact lenses when compared to each other after 15 minutes of daily wear each.

• Study Type: Interventional
• Enrollment (Actual): 40
• 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
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported visual exam in the last two years.
• Is an adapted soft contact lens wearer.
• Is not a habitual wearer of either study lens.
• Has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
• Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25D in both eyes.
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease.
• Has read, understood and signed the informed consent letter.
• Patient contact lens refraction should fit within the available parameters of the study lenses.
• Is willing to comply with the wear schedule (at least 5 days per week, >8 hours/day assuming there are no contraindications for doing so).
• Is willing to comply with the visit schedule.

Exclusion Criteria:

• Has a CL prescription outside the range of the available parameters of the study lenses.
• Has a spectacle cylinder less than -0.75D or more than -2.50D of cylinder in either eye.

• Slit lamp findings that would contraindicate contact lens wear such as:

  1. Pathological dry eye or associated findings
  2. Pterygium, pinguecula, or corneal scars within the visual axis
  3. Neovascularization > 0.75 mm in form of the limbus
  4. Giant papillary conjuctivitis (GCP) worse than grade 1
  5. Anterior uveitis or iritis (past or present)
  6. Seborrheic eczema, seborrheic conjunctivitis
  7. History of corneal ulcers or fungal infections
  8. Poor personal hygiene
  9. Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  10. Has aphakia, keratoconus or a highly irregular cornea.
  11. Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  12. Has undergone corneal refractive surgery.
  13. Is participating in any other type of eye related clinical or research study.

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
Overall Fit Acceptance	Overall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 4= Perfect)	At the end of 15 minutes of daily wear

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Ruben Guerrero, MSc, FIACLE, National Autonomous University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-157

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