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The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A | Experimental | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). |
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| delefilcon A | Active Comparator | Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A | Device | Each subject randomized to wear either the test or control in either the left of right eye. |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). | 12 Hours of Wear |
| Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). | 12 Hours of Wear |
| Moisture Retention (Mean) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). | 12 Hours of Wear |
| Moisture Retention (Median) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). | 12 Hours of Wear |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort of Stenfilcon A and Delefilcon A | Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent) | Up to 12 Hours of Wear |
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Inclusion Criteria:
Exclusion Criteria:
Is participating in any concurrent clinical study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Has undergone refractive error surgery;
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| Name | Affiliation | Role |
|---|---|---|
| Lydon Jones, PhD FC | Director, Centre for Contact Lens Research | Principal Investigator |
| Farah Panjwani, BSc RAQ | Univerisy of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo School of Optometry | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table |
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| 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 | Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). | There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs. | Posted | Mean | Standard Deviation | absolute WC change | 12 Hours of Wear |
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From dispense up to 12 hours for each 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 | Overall Participants | Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs | Coopervision | (925) 621-3761 | jvega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| delefilcon A | Device | Each subject randomized to wear either the test or control in either the left of right eye. |
|
| years |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Delefilcon A |
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye. |
|
|
| Secondary | Subjective Comfort of Stenfilcon A and Delefilcon A | Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent) | Posted | Mean | Standard Deviation | units on a scale | Up to 12 Hours of Wear |
|
|
|
| Primary | Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). | There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs. | Posted | Median | Full Range | absolute WC change | 12 Hours of Wear |
|
|
|
| Primary | Moisture Retention (Mean) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). | There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs. | Posted | Mean | Standard Deviation | percentage of dehyrdation | 12 Hours of Wear |
|
|
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| Primary | Moisture Retention (Median) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). | There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs. | Posted | Median | Full Range | percentage of dehyrdation | 12 Hours of Wear |
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Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
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