Clinical Evaluation of Two Toric Soft Contact Lenses

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Lens A (ocufilcon D); Device: Lens B (fanfilcon A)

• Registration Number: NCT06490302
• Lead Sponsor: Coopervision, Inc.

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

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-05-25
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 know history of corneal hypoesthesia (reduced corneal sensitivity)
  10. Has aphakia, kertaoconus 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens A (ocufilcon D)	Lens A (ocufilcon D)	All participants will wear lens A for 15 minutes (Period 1).
Lens B (fanfilcon A)	Lens B (fanfilcon A)	All participants will wear lens B for 15 minutes (Period 2).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Consultorio Optométrico Queretaro; 🇲🇽 Mexico City, Mexico