Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses

Clinical Performance of Habitual Wearers of Avaira Toric (Enfilcon A) When Refitted With Clariti Toric (Somofilcon A) Lenses for 1 Month.

The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: somofilcon A

Detailed Description

This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira toric lenses following a refit with Clariti toric lenses. Subject's habitual Avaira toric lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti toric lenses for 1 month of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Optometry Research Group (GIO) - Optics Department, University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 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 Avaira toric contact lens (CL) wearer (at least 1 week of wear in Avaira toric)
• Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)
• Have no less than 0.75D of astigmatism and no more than 1.75 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:

• Is not a habitual wearer of Avaira toric lenses
• 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 -1.75 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: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: enfilcon A; All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens	Device: somofilcon A; somofilcon A lens
EXPERIMENTAL: somofilcon A; All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens	Device: somofilcon A; somofilcon A lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity - Enfilcon A and Somofilcon A	Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.	Baseline, 1 week, 2 week, 4 week
Subjective Assessments- Enfilcon A and Somofilcon A	Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)	Baseline, 1 week, 2 week, 4 week

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Robert Montés-Mico, OD, Optometry Research Group (GIO)

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 24, 2014
• First Posted (ESTIMATE): September 25, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-53