Daily Disposable Comparison Study

The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: filcon II 3; Device: etafilcon A; Device: nelfilcon A

Detailed Description

This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
5. Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
6. Demonstrates an acceptable fit with the study lenses

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
7. Is aphakic;
8. Has undergone refractive error surgery;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: filcon II 3 and etafilcon A; Participants were randomized to a test and control lens for each group in a contralateral design.	Device: filcon II 3; Participants were randomized to wear filcon II 3 test lens.; Other Names: Hydrogel Daily Disposable Contact Lens; Device: etafilcon A; Participants were randomized to wear etafilcon A control lens.; Other Names: Hydrogel Daily Disposable Contact Lens; 1 Day Acuvue Moist
ACTIVE_COMPARATOR: filcon II 3 and nelfilcon A; Participants were randomized to a test and control lens for each group in a contralateral design.	Device: filcon II 3; Participants were randomized to wear filcon II 3 test lens.; Other Names: Hydrogel Daily Disposable Contact Lens; Device: nelfilcon A; Participants were randomized to wear nelfilcon A control lens.; Other Names: Dailies Aqua Comfort Plus; Hydrogel Daily Disposable Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A	Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).	Baseline visit
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A	Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).	3 hours
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A	Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Comfort - Filcon II 3 and Etafilcon A	Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).	Baseline, 3 hours, 6 hours
Lens Comfort - Filcon II 3 and Nelficon A	Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).	Baseline, 3 hours, 6 hours
Lens Dryness - Filcon II 3 and Etafilcon A	Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).	3 hours and 6 hours
Lens Dryness - Filcon II 3 and Nelfilcon A	Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).	3 hours and 6 hours
Lens Handling - Filcon II 3 and Etafilcon A	Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).	Baseline visit
Lens Handling - Filcon II 3 and Nelfilcon A	Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).	Baseline visit
Lens Handling (Removal) - Filcon II 3 and Etafilcon A	Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).	6 hours
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A	Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).	6 hours
Lens Wettability - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).	Baseline and 6 hours
Lens Wettability - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).	Baseline and 6 hours
Lens Fit, Centration - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I). N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior	Baseline
Lens Fit, Centration - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior	6 hours
Lens Fit, Centration - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior	Baseline
Lens Fit, Centration - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior	After 6 hours
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).	Baseline and 6 hours
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).	Baseline and 6 hours
Lens Fit, Tightness - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).	Baseline and 6 hours
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).	Baseline and 6 hours
Lens Surface Deposition - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).	6 hour
Lens Surface Deposition - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).	6 hour
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).	Baseline and 6 hours
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)	Baseline and 6 hours
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone). N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central	6 hours
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone). N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central	6 hours
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A	The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).	Baseline and 6 hours
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A	The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).	Baseline and 6 hours

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (ESTIMATE): March 24, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 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; Myopia
• Other Study ID Numbers: EX-MKTG-50