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This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.
The study results were not used for design validation of test lens.
Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month.
The study results were not used for design validation of test lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sapphire lens | Experimental | Each subject will be randomized to wear the test lens on one eye and control lens on one eye. |
|
| enfilcon A | Active Comparator | Each subject will be randomized to wear the test lens on one eye and control lens on one eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sapphire Lens | Device | Each subject will be randomized to wear the test lens on one eye and control lens on one eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings for Comfort After Lens Insertion | Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever | Baseline (5 minutes post lens dispensing) |
| Subjective Ratings for Comfort After Lens Insertion | Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever | 4 weeks |
| Percentage of Participants With a Lens Preference Based on Subjective Comfort | Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference | Baseline (5 minutes post lens dispensing) |
| Percentage of Participants With a Lens Preference Based on Subjective Comfort | Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference | 4 weeks |
| Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | Baseline (5 minutes post lens dispensing) |
| Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | 4 weeks |
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Inclusion Criteria:
Subjects will only be eligible for the study if:
Is at least 18 years of age for the USA 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 an adapted soft contact lens wearer;
Requires spectacle lens powers between -0.50 to -6.50 diopters sphere;
Has no more than 0.75 diopters of refractive astigmatism;
Willing to wear contact lens in both eyes;
Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.
Exclusion Criteria:
Subjects will not be eligible to take part in the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Meng Lin | Clinical Research Center, University of California, Berkeley | Principal Investigator |
| 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 | Sapphire Lenses | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact Lenses |
| FG001 | Enfilcon A | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: Contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
18 subjects were fit with study lenses and one subject discontinued at the dispensing visit due to dissatisfaction with both study lenses. Baseline demographic information is gathered for 17 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to wear test lens in one eye and control lens in other eye for a one month period. |
| 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 | Subjective Ratings for Comfort After Lens Insertion | Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever | Posted | Mean | Standard Deviation | units on a scale | Baseline (5 minutes post lens dispensing) | Eyes | Eyes |
|
From dispense up to 4 weeks on the 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 | Sapphire Lenses | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact Lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen | CooperVision, Inc. | 925-730-6716 | mnguyen@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| enfilcon A | Device | Each subject will be randomized to wear the test lens on one eye and control lens on one eye. |
|
| Lens Surface Deposition | Lens Surface Deposit was assessed on a scale of 0-4 (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 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface) | Baseline (5 minutes post lens dispensing) |
| Lens Surface Deposition | Lens Surface Deposit was assessed on a scale of 0-4 (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 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface) | 4 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Subjective Ratings for Comfort After Lens Insertion | Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever | Posted | Mean | Standard Deviation | units on a scale | 4 weeks | Eyes | Eyes |
|
|
|
| Primary | Percentage of Participants With a Lens Preference Based on Subjective Comfort | Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference | Posted | Number | percentage of participants | Baseline (5 minutes post lens dispensing) |
|
|
|
| Primary | Percentage of Participants With a Lens Preference Based on Subjective Comfort | Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference | Posted | Number | percentage of participants | 4 weeks |
|
|
|
| Primary | Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | Posted | Mean | Standard Deviation | units on a scale | Baseline (5 minutes post lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | Posted | Mean | Standard Deviation | units on a scale | 4 weeks | Eyes | Eyes |
|
|
|
| Primary | Lens Surface Deposition | Lens Surface Deposit was assessed on a scale of 0-4 (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 0.5amm 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 (5 minutes post lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | Lens Surface Deposition | Lens Surface Deposit was assessed on a scale of 0-4 (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 0.5amm 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 | Eyes | Eyes |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Enfilcon A | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: Contact lenses | 0 | 18 | 0 | 18 | 0 | 18 |
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| Measurements |
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