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To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.
This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sapphire | Experimental | Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. |
|
| senofilcon A | Active Comparator | Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sapphire | Device | silicone-hydrogel contact lens |
| |
| senofilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | Baseline (10 minutes post lens settling at dispense) |
| Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | 2 weeks - During the Day |
| Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | 2 weeks - End of Day |
| Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Baseline - 10 minutes post lens settling |
| Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | 2-weeks - During the Day |
| Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | 2-weeks - End of Day |
| Lens Surface Wettability | Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng Lin, OD PhD | University of California, Berkeley | Principal Investigator |
| Lyndon Jones, PhD FCO | University of Waterloo CCLR | 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 Lens Then Senofilcon A | Participants were randomized to wear the Sapphire lens pair for two weeks then cross over to Senofilcon A pair for two weeks. Sapphire Lens: silicone-hydrogel contact lens senofilcon A: contact lens |
| FG001 | Senofilcon A Then Sapphire Lens | Participants were randomized to wear the senofilcon A lens pair for two weeks then cross over to Sapphire lens pair for two weeks. senofilcon A: contact lens Sapphire lens: silicone-hydrogel 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 | Subjects were randomized to wear either the test lens or the control lens for 2 weeks and then cross-over to the other lens. Test Lens: Sapphire (contact lens) Control Lens : Senofilcon A (contact lens) |
| 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 | Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | Posted | Mean | Standard Deviation | units on a scale | Baseline (10 minutes post lens settling at dispense) |
|
From dispense up to 2 weeks for each study lenses, a total of 4 weeks
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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 | Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore Throat and Fever | Infections and infestations | Systematic Assessment |
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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 |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
| Baseline (10 minutes post lens settling) |
| Lens Surface Wettability | Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent) | 2 weeks |
| Surface Deposits | Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface) | Baseline (10 minutes post lens settling) |
| Surface Deposits | Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface) | 2-weeks |
| Lens Handling (Ease of Insertion) | Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye. | 2 weeks |
| Lens Handling (Ease of Removal) | Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye. | 2 weeks |
| Subjective Preference for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Baseline - 10 minutes post lens settling |
| Subjective Preference for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | 2 weeks |
| Center for Contact Lens Research, University of Waterloo |
| Waterloo |
| Ontario |
| N2L 3G1 |
| Canada |
| NOT COMPLETED |
|
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks - During the Day |
|
|
|
| Primary | Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks - End of Day |
|
|
|
| Primary | Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Posted | Mean | Standard Deviation | units on a scale | Baseline - 10 minutes post lens settling |
|
|
|
| Primary | Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Posted | Mean | Standard Deviation | units on a scale | 2-weeks - During the Day |
|
|
|
| Primary | Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Posted | Mean | Standard Deviation | units on a scale | 2-weeks - End of Day |
|
|
|
| Primary | Lens Surface Wettability | Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent) | Posted | Mean | Standard Deviation | units on a scale | Baseline (10 minutes post lens settling) | Eyes | Eyes |
|
|
|
| Primary | Lens Surface Wettability | Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | Eyes | Eyes |
|
|
|
| Primary | Surface Deposits | Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface) | Posted | Mean | Standard Deviation | units on a scale | Baseline (10 minutes post lens settling) |
|
|
|
| Primary | Surface Deposits | Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface) | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
|
|
|
| Primary | Lens Handling (Ease of Insertion) | Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Lens Handling (Ease of Removal) | Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Subjective Preference for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Posted | Number | percentage of participants | Baseline - 10 minutes post lens settling |
|
|
|
| Primary | Subjective Preference for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Posted | Number | percentage of participants | 2 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 2 |
| 32 |
| EG001 | Senofilcon A | Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens | 0 | 32 | 0 | 32 | 2 | 32 |
| Corneal Staining | Eye disorders | Systematic Assessment |
|
| Pelvic infection | Infections and infestations | Systematic Assessment |
|
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