Performance of Toric Silicone Hydrogel Contact Lenses

Performance of Two Toric Silicone Hydrogel Contact Lenses

The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Lens A (fanfilcon A); Device: Lens B (asmofilcon A)

Detailed Description

This was a prospective, randomized, double masked, bilateral, crossover study. Participants were expected to attend 6 scheduled visits over a period of approximately 2 months.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Código
    • Mexico City, Código, Mexico, 54090
      • National Autonomous University (UNAM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• 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 +4.00 to - 10.00 (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 -2.25 D 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 information 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:

A person will be excluded from the study if he/she:

• A person was excluded from the study if he/she:
• 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 -2.50 D of cylinder in either eye.
• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
• Presence of clinically significant (grade 2-4) anterior segment abnormalities
• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
• 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 from of the limbus
• Giant papillary conjunctivitis (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.
• 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: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A, then Lens B; Participants wore Lens A for one month and then wore Lens B for one month.	Device: Lens A (fanfilcon A); Daily wear for one month; Device: Lens B (asmofilcon A); Daily wear for one month
Experimental: Lens B, then Lens A; Participants wore Lens B for one month and then wore Lens A for one month.	Device: Lens A (fanfilcon A); Daily wear for one month; Device: Lens B (asmofilcon A); Daily wear for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling (Insertion and Removal)	Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.	1 month

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Rubén Velázquez Guerrero, MSc, FIACLE, National Autonomous University (UNAM)

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2021
• Primary Completion (Actual): December 8, 2021
• Study Completion (Actual): December 8, 2021

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-128

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