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Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test lens | Experimental | Subjects wearing the test contact lens either as first or second pair during the cross-over study. |
|
| Control lens | Active Comparator | Subjects wearing the control contact lens either as first or second pair during the cross-over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test lens | Device | Contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | Baseline |
| Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | 2-weeks |
| Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | 4-weeks |
| Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface) |
| Measure | Description | Time Frame |
|---|---|---|
| Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Baseline |
| Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, University of California, Berkeley | Berkeley | California | 94704 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens Then Control Lens | Subjects were randomized to wear test lens for one month then control lens for one month during the cross-over study. Test lens: Contact lens Control lens: Contact lens |
| FG001 | Control Lens Then Test Lens | Subjects were randomized to wear control lens for one month then test lens for one month during the cross-over study. Test lens: Contact lens Control lens: Contact lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total participants |
| 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 | Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
From dispense up to 4-weeks on each type 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 | Test Lens | Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen | CooperVision, Inc. | 925-730-6716 | mnguyen@coopervision.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 | Apr 10, 2018 | Jun 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.
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This will be a double-masked study in which both participant and investigator will be masked.
| Control lens | Device | Contact lens |
|
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| Baseline |
| Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface). | 2-weeks |
| Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface) | 4-weeks |
| Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | Baseline |
| Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | 2-Weeks |
| Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | 4-Weeks |
| Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | Baseline |
| Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | 2-weeks |
| Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | 4-weeks |
| 2-weeks |
| Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | 4-weeks |
| Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Baseline |
| Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | 2-weeks |
| Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | 4-weeks |
| Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University |
| Bloomington |
| Indiana |
| 47405 |
| United States |
| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|
| Primary | Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
|
|
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| Primary | Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
|
|
|
| Primary | Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface). | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
|
|
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| Primary | Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface) | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
|
|
|
| Primary | Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | Posted | Mean | Standard Deviation | units on a scale | 2-Weeks |
|
|
|
| Primary | Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | Posted | Mean | Standard Deviation | units on a scale | 4-Weeks |
|
|
|
| Primary | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Primary | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | Posted | Number | percentage of participants | 2-weeks |
|
|
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| Primary | Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | Posted | Number | percentage of participants | 4-weeks |
|
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| Secondary | Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
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| Secondary | Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
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| Secondary | Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
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| Secondary | Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
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|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Control Lens | Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens | 0 | 46 | 0 | 46 | 0 | 46 |
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| Extremely Decentered |
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| Extremely Decentered |
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| Extremely Decentered |
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