Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

Non-Dispensing Fitting Study Comparing the Clinical Performance of Hydrogel vs. Silicone Hydrogel Sphere Design Contact Lenses

The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: omafilcon A; Device: ocufilcon D; Device: methafilcon A

Detailed Description

This is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different lens materials (hydrogel vs silicone hydrogel). It is anticipated that this study will involve 2 visits, for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear the test and control lenses in a series of three short fitting comparisons.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46100
    • Optometry Research Group (GIO) Optics Department, University of Valencia

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 CL (Contact Lens) wearer
• Has a CL spherical prescription between - 1.00 and - 10.00 (inclusive)
• Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
• 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
• Is willing to comply with the visit schedule

Exclusion Criteria:

• Has never worn contact lenses before.
• Currently wears rigid gas permeable contact lenses.
• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
• Has a CL prescription outside the range of - 1.00 to -10.00D
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enfilcon A / omafilcon A; Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.	Device: omafilcon A; Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.; Other Names: Hydrogel Contact Lens
Active Comparator: enfilcon A / ocufilcon D; Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.	Device: ocufilcon D; Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.; Other Names: Hydrogel Contact Lens
Active Comparator: enfilcon A / methafilcon A; Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.	Device: methafilcon A; Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.; Other Names: Hydrogel Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A	Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).	1 hour post settling
Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D	Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).	1 hour post settling
Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A	Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).	1 hour post settling
Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D	Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).	Baseline
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A	Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).	Baseline
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A	Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).	Baseline
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A	Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel).	1 hour post settling
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D	Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).	1 hour post settling
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A	Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).	1 hours post settling
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A	Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).	Baseline
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D	Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).	Baseline
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A	Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).	Baseline
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A	Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).	1 hour post settling
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D	Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).	1 hour post settling
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A	Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A	Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D	Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A	Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A	Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D	Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A	Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A	Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D	Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)	1 hour post settling
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A	Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)	1 hour post settling
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A	Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).	Baseline
Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D	Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)	Baseline
Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A	Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).	Baseline
Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A	Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).	1 hour post settling
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D	Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).	1 hour post settling
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A	Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).	1 hour post settling
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A	Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)	1 hour post settling
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D	Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)	1 hour post settling
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A	Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)	1 hour post settling

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Robert Montés-Mico, OD MPhil PhD, Optics Department, University of Valencia

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: May 2, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-47