Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Fanfilcon A toric lens; Device: Lotrafilcon B toric lens

Detailed Description

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Optometry Clinic, National Autonomous University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
• Have 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:

• 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: fanfilcon A toric; Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study.	Device: Fanfilcon A toric lens; Contact lens; Other Names: Avaira Vitality toric lens
Active Comparator: lotrafilcon B; Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study.	Device: Lotrafilcon B toric lens; Contact lens; Other Names: AIR OPTIX for Astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Centration	Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)	Baseline
Lens Centration	Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)	Dispense
Lens Centration	Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)	1 Month
Corneal Coverage	Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)	Baseline
Corneal Coverage	Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)	Dispense
Corneal Coverage	Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)	1 Month
Post-blink Movement	Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)	Baseline
Post-blink Movement	Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)	Dispense
Post-blink Movement	Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)	1 Month
Overall Fit Acceptance	Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)	Dispense
Overall Fit Acceptance	Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)	1 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Hours of Wear Per Day	Number of hours lenses are worn per day	Baseline
Average Hours of Wear Per Day	Number of hours lenses are worn per day	1 month
Average Comfortable Wearing Time	Typical time of day when subject first experiences lens awareness or irritation.	Baseline
Average Comfortable Wearing Time	Typical time of day when subject first experiences lens awareness or irritation	1 Month

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2018
• Primary Completion (Actual): May 16, 2018
• Study Completion (Actual): May 16, 2018

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-90

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