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Clinical Performance of Stenfilcon vs. Filcon II 3
The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A | Experimental | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
|
| filcon II 3 | Active Comparator | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A | Device | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily and Comfortable Wearing Time | Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.) | Baseline |
| Daily and Comfortable Wearing Time | Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.) | 1 week |
| Handling | Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily). | 1 Week |
| Comfort | Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all) | Baseline |
| Comfort | Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all). | 1 Week |
| Dryness | Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all) | Baseline |
| Dryness |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Vessel Coverage | Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage. | Baseline |
| Blood Vessel Coverage | Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage. |
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Inclusion Criteria:
Subjects must satisfy the following conditions prior to inclusion in the study:
Exclusion Criteria:
Any of the following will render a subject ineligible for inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| James Wolffsohn, PhD | University of Aston Birmingham, West Midlands, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Aston | Birmingham | West Midlands | B4 7ET | United Kingdom |
All subjects were habitual lens wearers and were randomized to each pair of study lenses. Only one patient failed to complete all study visits and their data was excluded from the analysis.
Sixty habitual contact lens wearing subjects were recruited by the Optometry Clinic at Aston University
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| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A Then Filcon II 3 | All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week. |
| FG001 | Filcon II 3 Then Stenfilcon A | All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stenfilcon A Then Filcon II 3 | All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Daily and Comfortable Wearing Time | Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.) | Posted | Mean | Standard Deviation | hours | Baseline |
|
|
From dispense up to one week for each pair of 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 | Stenfilcon A | All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Walker | Opthalmic Research Group, Aston University, Birmingham, UK | JWalker@coopervision.co.uk |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| filcon II 3 | Device | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
|
|
Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
| 1 Week |
| Vision Quality | Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp) | Baseline |
| Vision Quality | Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp) | 1 Week |
| Eye Whiteness | Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white). | Baseline |
| Eye Whiteness | Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white). | 1 Week |
| Overall Satisfaction | Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied). | Baseline |
| Overall Satisfaction | Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied). | 1 Week |
| Visual Acuity logMAR | Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR. | Baseline |
| Visual Acuity logMAR | Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR. | Dispense |
| Visual Acuity logMAR | Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR | 1 Week |
| Wettability | Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds. | 1 Week |
| 1 Week |
| Conjunctival Redness | Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness. | Baseline |
| Conjunctival Redness | Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness. | 1 Week |
| Corneal Staining | Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe ) | Baseline |
| Corneal Staining | Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe ) | 1 Week |
| Conjunctival Staining | Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe ) | 1 Week |
| Filcon II 3 Then Stenfilcon A |
All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Daily and Comfortable Wearing Time | Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.) | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | hours | 1 week |
|
|
|
| Primary | Handling | Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily). | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Comfort | Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all) | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Comfort | Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all). | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Dryness | Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all) | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Blood Vessel Coverage | Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage. | Prior to randomization | Posted | Mean | Standard Deviation | percentage of blood vessel coverage | Baseline | Eyes | Eyes |
|
|
|
| Primary | Dryness | Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all). | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Vision Quality | Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Vision Quality | Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp) | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Eye Whiteness | Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Eye Whiteness | Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white). | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Overall Satisfaction | Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Overall Satisfaction | Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied). | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Primary | Visual Acuity logMAR | Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR. | Posted | Mean | Standard Deviation | logMAR | Baseline |
|
|
|
| Primary | Visual Acuity logMAR | Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR. | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | logMAR | Dispense |
|
|
|
| Primary | Visual Acuity logMAR | Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | logMAR | 1 Week |
|
|
|
| Secondary | Blood Vessel Coverage | Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage. | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | percentage of blood vessel coverage | 1 Week | Eyes | Eyes |
|
|
|
| Secondary | Conjunctival Redness | Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness. | Posted | Mean | Standard Deviation | percentage of redness | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Conjunctival Redness | Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness. | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | percentage of redness | 1 Week | Eyes | Eyes |
|
|
|
| Secondary | Corneal Staining | Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe ) | Prior to randomization | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Corneal Staining | Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe ) | Posted | Mean | Standard Deviation | units on a scale | 1 Week | Eyes | Eyes |
|
|
|
| Secondary | Conjunctival Staining | Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe ) | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | units on a scale | 1 Week | Eyes | Eyes |
|
|
|
| Primary | Wettability | Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds. | All 59 subjects were habitual lens wearers and randomized to both sets of study lenses. | Posted | Mean | Standard Deviation | seconds | 1 Week | Eyes | Eyes |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Filcon II 3 | All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. | 0 | 60 | 0 | 60 |
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. Assuming that the product is marketed, and only with the sponsor's permission, will they allow publication of the results of the study.
| Insertion |
|
| Removal |
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| Title | Measurements |
|---|---|
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| On Removal |
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| After 8 hours |
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| Removal |
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| Title | Measurements |
|---|---|
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| On Removal |
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| After 8 hours |
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| Removal |
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| BHCVA |
|