Daily Disposable Comparison Study

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: filcon II 3
Device: etafilcon A
Device: nelfilcon A

Registration Number: NCT02094677

Lead Sponsor: Coopervision, Inc.

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
filcon II 3 and etafilcon A	etafilcon A	Participants were randomized to a test and control lens for each group in a contralateral design.
filcon II 3 and etafilcon A	filcon II 3	Participants were randomized to a test and control lens for each group in a contralateral design.
filcon II 3 and nelfilcon A	nelfilcon A	Participants were randomized to a test and control lens for each group in a contralateral design.
filcon II 3 and nelfilcon A	filcon II 3	Participants were randomized to a test and control lens for each group in a contralateral design.

Primary Outcome Measures

Name	Time	Method
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A	6 hours	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).

Secondary Outcome Measures

Name	Time	Method
Lens Comfort - Filcon II 3 and Nelficon A	Baseline, 3 hours, 6 hours	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).
Lens Handling - Filcon II 3 and Etafilcon A	Baseline visit	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).
Lens Dryness - Filcon II 3 and Etafilcon A	3 hours and 6 hours	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).
Lens Fit, Tightness - Filcon II 3 and Etafilcon A	Baseline and 6 hours	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).
Lens Surface Deposition - Filcon II 3 and Etafilcon A	6 hour	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).
Lens Surface Deposition - Filcon II 3 and Nelfilcon A	6 hour	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).
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A	Baseline and 6 hours	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).
Lens Comfort - Filcon II 3 and Etafilcon A	Baseline, 3 hours, 6 hours	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).
Lens Dryness - Filcon II 3 and Nelfilcon A	3 hours and 6 hours	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).
Lens Handling - Filcon II 3 and Nelfilcon A	Baseline visit	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).
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A	6 hours	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).
Lens Wettability - Filcon II 3 and Etafilcon A	Baseline and 6 hours	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).
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A	Baseline and 6 hours	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).
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A	Baseline and 6 hours	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).
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A	6 hours	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
Lens Handling (Removal) - Filcon II 3 and Etafilcon A	6 hours	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).
Lens Fit, Centration - Filcon II 3 and Etafilcon A	6 hours	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
Lens Fit, Centration - Filcon II 3 and Nelfilcon A	After 6 hours	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
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A	Baseline and 6 hours	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).
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A	Baseline and 6 hours	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)
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A	6 hours	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
Lens Wettability - Filcon II 3 and Nelfilcon A	Baseline and 6 hours	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).
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A	Baseline and 6 hours	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).
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A	Baseline and 6 hours	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).