Clinical Evaluation of Two Toric Soft Contact Lenses

NCT06490302 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-157
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• 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

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 - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Pathological dry eye or associated findings
• Pterygium, pinguecula, or corneal scars within the visual axis
• Neovascularization \> 0.75 mm in form of the limbus
• Giant papillary conjuctivitis (GCP) worse than grade 1
• Anterior uveitis or iritis (past or present)
• Seborrheic eczema, seborrheic conjunctivitis
• History of corneal ulcers or fungal infections
• Poor personal hygiene
• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• Has aphakia, keratoconus or a highly irregular cornea.
• Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
• Has undergone corneal refractive surgery.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Consultorio Optométrico Queretaro

Mexico City, 06760, Mexico

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

javega@coopervision.com

9256213761

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: June 28, 2024
• First Posted: July 8, 2024
• Study Start: May 24, 2024
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Locations

ME (1)