Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966770
• Other study ID #: EX-MKTG-44
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.

Description:

This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

• Has a cl spherical prescription between -1.00 and -6.00 (inclusive)

• Has a spectacle cylinder up to 0.75D (diopter) in each eye

• Is correctable to a visual acuity of 20/25 or better in both eyes

• Has clear corneas and no active ocular disease

• Has read, understood and signed the information consent letter

• Is willing to comply with the wear schedule

• Is willing to comply with the visit schedule

Exclusion Criteria:

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

• Has never worn contact lenses before

• Currently wears rigid gas permeable contact lenses

• Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)

• Has a contact lens prescription outside the range of -1.00 to -6.00D

• Has a spectacle cylinder = 1.00D of cylinder in either eye

• Has best corrected spectacle distance vision worse than 20/25 in either eye

• Has any systemic or topical medications that will affect ocular health

• Has any ocular pathology or severe insufficiency of lacrimal secretion

• Has persistent, clinically significant corneal or conjunctival staining

• Has active neovascularization or any central corneal scars

• Is aphakic

• Is presbyopic

• Has undergone corneal refractive surgery

• Is participating in any other type of eye related conical or research study

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Pair 1 (ocufilcon D / ocufilcon D)
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
• Pair 2 (ocufilcon D / enfilcon A)
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
• Pair 3 (ocufilcon D / comfilcon A)
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
• Pair 4 (methafilcon A / methafilcon A)
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
• Pair 5 (methafilcon A / comfilcon A)
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
• Pair 6 (omafilcon A / comfilcon A)
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)

Locations

Country	Name	City	State
United States	University of California, Berkeley Clinical Research Center (UCB-CRC)	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity (VA) logMAR (Habitual Lenses)	Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)	Baseline
Primary	Visual Acuity (VA) logMAR (Study Lenses)	Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)	Dispense
Primary	Comfort Contact Lens Insertion (Day 1 Study Lenses)	Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)	Day 1 - Insertion
Primary	Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)	Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)	Day 1 - 30 minutes
Primary	Comfort Contact Lens Insertion (Day 2 Study Lenses)	Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever	Day 2 - Insertion
Primary	Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)	Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever	Day 2 - 30 minutes
Primary	Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)	Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 1 - Insertion
Primary	Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)	Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 1 Insertion
Primary	Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)	Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 1 - Insertion
Primary	Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)	Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 1 - 30 minutes
Primary	Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)	Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 1 - 30 minutes
Primary	Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)	Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 1 - 30 minutes
Primary	Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)	Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 2 - Insertion
Primary	Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)	Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 2 - Insertion
Primary	Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)	Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 2 - Insertion
Primary	Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)	Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)	Day 2 - 30 minutes
Primary	Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)	Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)	Day 2 - 30 minutes
Primary	Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)	Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)	Day 2 - 30 minutes
Primary	Lens Fitting Characteristics, Centration (Habitual Lens)	Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)	Baseline
Primary	Lens Fitting Characteristics, Tightness (Habitual Lens)	Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)	Baseline
Primary	Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)	Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)	Baseline
Primary	Lens Fitting Characteristics, Centration (Day 1 Study Lenses)	Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)	Day 1 - 30 minutes
Primary	Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)	Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)	Day 1 - 30 minutes
Primary	Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)	Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)	Day 1 - 30 minutes
Primary	Lens Fitting Characteristics, Centration (Day 2 Study Lenses)	Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)	Day 2 - 30 minutes
Primary	Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)	Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)	Day 2 - 30 minutes
Primary	Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)	Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)	Day 2 - 30 minutes
Primary	Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)	Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)	Day 1- 30 minutes
Primary	Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)	Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)	Day 1- 30 minutes
Primary	Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)	Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)	Day 1 - 30 minutes
Primary	Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)	Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)	Day 2 - Insertion
Primary	Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)	Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)	Day 2 - Insertion
Primary	Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)	Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)	Day 2 - Insertion
Primary	Overall Ease of Lens Handling (Day 1 Study Lenses)	Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy	Day 1 - After Removal
Primary	Overall Ease of Lens Handling (Day 2 Study Lenses)	Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy	Day 2 - After Removal