Daily Disposable Comparison Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Daily Disposable Comparison Study

Conditions
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Myopia

Intervention / Treatment
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* Device: filcon II 3
* Device: etafilcon A
* Device: nelfilcon A


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |