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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| filcon II 3 and etafilcon A | Active Comparator | Participants were randomized to a test and control lens for each group in a contralateral design. |
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| filcon II 3 and nelfilcon A | Active Comparator | Participants were randomized to a test and control lens for each group in a contralateral design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filcon II 3 | Device | Participants were randomized to wear filcon II 3 test lens. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
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Seventy four participants were enrolled into the study and 70 participants were randomized and completed the study. 40 were habitual wearers of etafilcon A lens and 30 were habitual wearers of nelfilcon A lens.
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| ID | Title | Description |
|---|---|---|
| FG000 | Filcon II 3 and Etafilcon A | Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens. |
| FG001 | Filcon II 3 and Nelfilcon A | Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Filcon II 3 and Etafilcon A | Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens. |
| BG001 | Filcon II 3 and Nelfilcon A |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | Baseline visit |
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From dispense up to 2 days for each study lenses
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Filcon II 3 and Etafilcon A | Participants wear one of their habitual brand lenses (etafilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye. filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other. etafilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs | Coopervision | (925) 621-3761 | jvega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| etafilcon A | Device | Participants were randomized to wear etafilcon A control lens. |
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| nelfilcon A | Device | Participants were randomized to wear nelfilcon A control lens. |
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| 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 |
Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Filcon II 3 and Nelfilcon A |
Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens. |
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| Primary | 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). | Posted | Number | participants | 3 hours |
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| Primary | 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). | Posted | Number | participants | 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 hours, 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 hours, 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed. | Posted | Mean | Standard Deviation | units on a scale | 3 hours and 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed. | Posted | Mean | Standard Deviation | units on a scale | 3 hours and 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed. | Posted | Mean | Standard Deviation | units on a scale | Baseline visit |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed. | Posted | Mean | Standard Deviation | units on a scale | Baseline visit |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed. | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed. | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 hours |
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| Secondary | 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 | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Number | participants | Baseline |
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| Secondary | 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 | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Number | participants | 6 hours |
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| Secondary | 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 | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Number | participants | Baseline |
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| Secondary | 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 | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Number | participants | After 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Mean | Standard Deviation | mm steps | Baseline and 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Mean | Standard Deviation | mm steps | Baseline and 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Mean | Standard Deviation | percentage of tightness | Baseline and 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Mean | Standard Deviation | percentage of tightness | Baseline and 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Mean | Standard Deviation | units on a scale | 6 hour |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Mean | Standard Deviation | units on a scale | 6 hour |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Mean | Standard Deviation | logMAR | Baseline and 6 hours |
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| Secondary | 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) | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Mean | Standard Deviation | logMAR | Baseline and 6 hours |
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| Secondary | 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 | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Mean | Standard Deviation | percentage of the area of each zone | 6 hours |
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| Secondary | 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 | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Mean | Standard Deviation | percentage of the area of each zone | 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 hours |
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| Secondary | 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). | These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 hours |
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| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Filcon II 3 and Nelfilcon A | Participants wear one of their habitual brand lenses (nelfilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye. filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other. nelfilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other. | 0 | 30 | 0 | 30 |
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
| No preference |
|
| Slightly prefer etafilcon A/nelfilcon A |
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| Strongly prefer etafilcon A/nelfilcon A |
|
| No preference |
|
| Slightly prefer etafilcon A/nelfilcon A |
|
| Strongly prefer etafilcon A/nelfilcon A |
|
| 3 hours |
|
| 6 hours |
|
| 3 hours |
|
| 6 hours |
|
| 6 hours |
|
| 6 hours |
|
| T |
|
| S |
|
| I |
|
| N/S |
|
| N/I |
|
| T/S |
|
| T/I |
|
| T |
|
| S |
|
| I |
|
| N/S |
|
| N/I |
|
| T/S |
|
| T/I |
|
| T |
|
| S |
|
| I |
|
| N/S |
|
| N/I |
|
| T/S |
|
| T/I |
|
| T |
|
| S |
|
| I |
|
| N/S |
|
| N/I |
|
| T/S |
|
| T/I |
|
| S |
|
| I |
|
| C |
|
| S |
|
| I |
|
| C |
|