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This will be a 1-month dispensing, double-masked, randomized, contralateral study comparing the test lens against the control lens. The assignment of lenses to eyes (i.e. which lens type is to be worn in which eye throughout the study) will be selected according to a randomization table.
Both test and control lenses will be used in a daily wear modality for 1 month. It is anticipated that this study will involve the following visits: Baseline (screening and dispense visit combined), 2-week visit and 4-week visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sapphire lens | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sapphire Lens | Device | Each subject randomized to wear either the test or control in either the left of right eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Comfort | Subjective ratings of 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 (After 10 minutes of lens dispense) |
| Subjective Ratings of Comfort | Subjective ratings of 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 | 2 weeks |
| Subjective Ratings of Comfort | Subjective ratings of 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 |
| Subjective Comfort Preference | Subjective comfort preference Sapphire lens, Enfilcon A, no preference | Baseline (after 10 minutes of lens dispense) |
| Subjective Comfort Preference | Subjective comfort preference Sapphire lens, Enfilcon A, no preference | 2 weeks |
| Subjective Comfort Preference | Subjective comfort preference Sapphire lens, Enfilcon A, no preference | 4 weeks |
| Lens Wettability |
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Inclusion Criteria:
Exclusion Criteria:
For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).
^ For the purposes of this study, participants will be excluded, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones | University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | 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 lens. Enfilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 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 lens. Enfilcon 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 | Subjective Ratings of Comfort | Subjective ratings of 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 (After 10 minutes of lens dispense) | eyes | eyes |
|
From dispense up to one month on 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 Lens | 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 lens |
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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 randomized to wear either the test or control in either the left of right eye. |
|
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) |
| Baseline (After 10 minutes of lens dispense) |
| Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | 2 weeks |
| Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | 4 weeks |
| 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Subjective Ratings of Comfort | Subjective ratings of 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 | 2 weeks | eyes | eyes |
|
|
|
| Primary | Subjective Ratings of Comfort | Subjective ratings of 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 | Subjective Comfort Preference | Subjective comfort preference Sapphire lens, Enfilcon A, no preference | Posted | Number | percentage of eyes | Baseline (after 10 minutes of lens dispense) | Eyes | Eyes |
|
|
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| Primary | Subjective Comfort Preference | Subjective comfort preference Sapphire lens, Enfilcon A, no preference | Posted | Number | percentage of eyes | 2 weeks | Eyes | Eyes |
|
|
|
| Primary | Subjective Comfort Preference | Subjective comfort preference Sapphire lens, Enfilcon A, no preference | Posted | Number | percentage of eyes | 4 weeks | 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 | Baseline (After 10 minutes of lens dispense) | 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 | 2 weeks | 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 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| 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 lens | 0 | 17 | 0 | 17 | 0 | 17 |
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| Title | Measurements |
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| Title | Measurements |
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