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This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C 8.5\C 9.0\T 8.5\T 9.0 | Experimental | Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period. |
|
| C 9.0\C 8.5\T 9.0\T 8.5 | Experimental | Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period. |
|
| T 8.5\T 9.0\C 8.5\C 9.0 | Experimental | Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period. |
|
| T 9.0\T 8.5\C 9.0\C 8.5 | Experimental | Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test 8.5BC | Device | senofilcon A contact lenses with 8.5 base curve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Fit Acceptance | Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported. | 30-45 minutes after lens settling |
| Lens Power Requirement | The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control). | 30-45 minutes after lens settling |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort at Lens Insertion | Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported. | Immediately upon lens insertion |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aston University Optometry and Vision Science | Birmingham | United Kingdom | ||||
| Visioncare Research |
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A total of 51 subjects were enrolled in the study from two sites. Of those enrolled, 50 subjects were randomized and 50 subjects were dispensed a study lens. All 50 subjects completed the study, while no one discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | C 8.5\C 9.0\T 8.5\T 9.0 | Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period. |
| FG001 | C 9.0\C 8.5\T 9.0\T 8.5 | Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period. |
| FG002 | T 8.5\T 9.0\C 8.5\C 9.0 | Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period. |
| FG003 | T 9.0\T 8.5\C 9.0\C 8.5 | Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | All subjects who were administered any test article excluding subjects who drop out prior to administering any test article |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Overall Fit Acceptance | Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported. | All subjects who had successfully completed all required assessments visits without any a major protocol deviations. | Posted | Count of Units | Eyes | 30-45 minutes after lens settling | Eyes | Eyes |
|
Throughout the entire duration of the study, approximately 1 day per subject.
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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 | Test 8.5BC | Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Sulley BSc MCOptom FAAO | Johnson & Johnson Vision | +44 1344864043 | asulley1@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2017 | Oct 18, 2018 | Prot_SAP_000.pdf |
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Contra-lateral Assignment
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Both the investigator and the subjects are masked to the identity of the study lenses. Lenses were over-labelled and coded to mask the lens foil. Over-labelling was carried out by the study sponsor following specific SOPs (see ICH GCP guidelines Section 5.13).
|
| Test 9.0BC | Device | senofilcon A contact lenses with 9.0 base curve |
|
| Control 8.5BC | Device | narafilcon A contact lenses with 8.5 base curve |
|
| Control 9.0BC | Device | narafilcon A contact lenses with 9.0 base curve |
|
| Subjective Comfort After Lens Settling |
Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported. |
| 30-45 minutes after lens settling |
| Subjective Vision Quality | Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported. | 30-45 minutes after lens settling |
| Subjective Handling | Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported. | Immediately upon lens insertion |
| Monocular High Contrast Visual Acuity (VA) | Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type. | 30-45 minutes after lens settling |
| Farnham |
| United Kingdom |
| Discontinued |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation. |
| OG002 | Control 8.5BC | Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation. |
| OG003 | Control 9.0BC | Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation. |
|
|
|
| Primary | Lens Power Requirement | The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control). | All subjects who had successfully completed all required assessments without a major protocol deviation. | Posted | Count of Units | Eyes | 30-45 minutes after lens settling | Eyes | Eyes |
|
|
|
|
| Secondary | Subjective Comfort at Lens Insertion | Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported. | All subjects who had successfully completed all required assessments without a major protocol deviation. | Posted | Mean | Standard Deviation | Graded Scale 0-10 | Immediately upon lens insertion | Eyes | Eyes |
|
|
|
|
| Secondary | Subjective Comfort After Lens Settling | Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported. | All subjects who had successfully completed all required assessments without a major protocol deviation. | Posted | Mean | Standard Deviation | Graded scale 0-10 | 30-45 minutes after lens settling | Eyes | Eyes |
|
|
|
|
| Secondary | Subjective Vision Quality | Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported. | All subjects who had successfully completed all required assessments without a major protocol deviation. | Posted | Mean | Standard Deviation | Graded scale 0-10 | 30-45 minutes after lens settling | Eyes | Eyes |
|
|
|
|
| Secondary | Subjective Handling | Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported. | All subjects who had successfully completed all required assessments without a major protocol deviation. | Posted | Mean | Standard Deviation | Graded scale 0-10 | Immediately upon lens insertion | Eyes | Eyes |
|
|
|
|
| Secondary | Monocular High Contrast Visual Acuity (VA) | Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type. | All subjects who had successfully completed all required assessments without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 30-45 minutes after lens settling | Eyes | Eyes |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Test 9.0BC | Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | Control 8.5BC | Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG003 | Control 9.0BC | Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation. | 0 | 50 | 0 | 50 | 0 | 50 |
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| Eyes |
|
| -3.50 to -3.00 |
|
| -2.75 to -2.25 |
|
| -2.00 t -1.50 |
|
| -1.25 to -0.75 |
|
| >= -0.50 |
|
| Wilson Method |
| Proportion (%) |
| 83.3 |
| 2-Sided |
| 97.5 |
| 68.3 |
| 92.1 |
Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated. |
| Equivalence |
Equivalence margin of 70% was used for no difference in lens power requirement. |
| Wilson Method | Proportion (%) | 100 | 2-Sided | 97.5 | 90.5 | 100 | Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated. | Equivalence | Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D. |
| Wilson Method | Proportion (%) | 100.0 | 2-Sided | 97.5 | 90.5 | 100.0 | Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated. | Equivalence | Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D. |
| Eyes |
|
| Linear mixed model |
Simulation-based adjustment was used to address the multiple comparisons. |
| Least square mean difference |
| 0.0 |
| 2-Sided |
| 95 |
| -0.5 |
| 0.5 |
| Non-Inferiority |
Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded. |
| Eyes |
|
| Linear mixed model |
Simulation-based adjustment was used to address the multiple comparisons. |
| Least square mean difference |
| 0.1 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.5 |
| Non-Inferiority |
Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded. |
| Eyes |
|
| Linear mixed model |
Simulation-based adjustment was used to address the multiple comparisons. |
| Least square mean difference |
| 0.1 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.3 |
| Non-Inferiority |
Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded. |
| Eyes |
|
| Linear mixed model |
Simulation-based adjustment was used to address the multiple comparisons. |
| Least square mean difference |
| -0.1 |
| 2-Sided |
| 95 |
| -0.6 |
| 0.4 |
| Non-Inferiority |
Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded. |
| Eyes |
|
| Linear mixed model |
Simulation-based adjustment was used to address the multiple comparisons. |
| Least square mean difference |
| -0.001 |
| 2-Sided |
| 95 |
| -0.012 |
| 0.009 |
| Non-Inferiority |
Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded. |