Clinical Evaluation of Two Toric Soft Contact Lenses

NCT ID: NCT06490302

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-24
• Study Completion Date: 2024-06-28

Brief Summary

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

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.

Conditions

Astigmatism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lens A (ocufilcon D)

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

Group Type: EXPERIMENTAL

Lens A (ocufilcon D)

Intervention Type: DEVICE

15 minutes of daily wear

Lens B (fanfilcon A)

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

Group Type: EXPERIMENTAL

Lens B (fanfilcon A)

Intervention Type: DEVICE

15 minutes of daily wear

Interventions

Lens A (ocufilcon D)

15 minutes of daily wear

Intervention Type: DEVICE

Lens B (fanfilcon A)

15 minutes of daily wear

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruben Guerrero, MSc, FIACLE

Role: PRINCIPAL_INVESTIGATOR

National Autonomous University

Locations

Consultorio Optométrico Queretaro

Mexico City, , Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-157

Identifier Type: -

Identifier Source: org_study_id