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This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.
The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.
Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silicone hydrogel lens (test) | Experimental | Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. |
|
| enfilcon A lens (control) | Active Comparator | Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silicone hydrogel lens (test) | Device | contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings 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. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week. | Baseline and 1 week |
| Dryness | Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week. | Baseline and 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Wettability | Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced. | Baseline and 1 week |
| Surface Appearance | Grade ratings category (smooth, grainy, or other) |
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Inclusion criteria:
-A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
-A person will be excluded from the study if he/she:
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, PhD FCO | Center for Contact Lens Research, 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 |
One participant discontinued from the study as a screen failure before lens randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control) | Participants were randomized to wear silicone hydrogel lens (test) for 1 week, then cross over to the enfilcon A lens (control). silicone hydrogel lens (test): contact lens enfilcon A lens (control): contact lens |
| FG001 | Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test) | Participants were randomized to wear enfilcon A lens (control) for 1 week, then cross over to the silicone hydrogel lens (test). enfilcon A lens (control): contact lens silicone hydrogel lens (test): contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
| |||||||||||||
| Second Intervention (1 Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline Characteristics | Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Comfort | Subjective ratings 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. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
From dispense up to one week 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 | Silicone Hydrogel Lens (Test) | Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager Clinical Research | CooperVision Inc. | (925) 730-6754 | PChamberlain@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| enfilcon A lens (control) |
| Device |
contact lens |
|
| Baseline |
| Surface Appearance | Grade ratings category (smooth, grainy, or other) | 1 week |
| High Contrast Acuity at High Room Illumination | Logarithm of the Minimum Angle or Resolution (LogMAR) Chart | Baseline and 1 week |
| Lens Deposition | Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced | Baseline and 1 week |
| Lens Problems | Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings. | Baseline and 1 week |
| Lens Centration | Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered. (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior | Baseline |
| Lens Centration | Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered. (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior | 1 week |
| Post-blink Movement | Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps) | Baseline and 1 week |
| Lens Tightness | Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement. | Baseline and 1 week |
| Visual Quality | Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week. | Baseline and 1 week |
| Ease of Lens Insertion | Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye | Baseline and 1 week |
| Ease of Lens Removal | Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye. | 1 week |
| Overall Lens Fit | Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);
| Baseline and 1 week |
| Bulbar Hyperemia | Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia. | Baseline and 1 week |
| Limbal Hyperemia | Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia. | Baseline and 1 week |
| Corneal Dehydration Staining | Corneal Staining: Dehydration Staining: Yes/No | 1 week |
| Corneal Staining (Extent) | Corneal staining extent, grade as % of each zone: C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior | Baseline and 1 week |
| Conjunctival Indentation | Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe | Baseline and 1 week. |
| Conjunctival Staining | Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent | Baseline and 1 week |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Dryness | Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
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| Secondary | Lens Wettability | Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Secondary | Surface Appearance | Grade ratings category (smooth, grainy, or other) | Posted | Number | Eyes | Baseline | Eyes | Eyes |
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| Secondary | Surface Appearance | Grade ratings category (smooth, grainy, or other) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
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| Secondary | High Contrast Acuity at High Room Illumination | Logarithm of the Minimum Angle or Resolution (LogMAR) Chart | Posted | Mean | Standard Deviation | LogMAR | Baseline and 1 week |
|
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| Secondary | Lens Deposition | Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
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| Secondary | Lens Problems | Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings. | Posted | Number | Lenses | Baseline and 1 week | Lenses | Lenses |
|
|
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| Secondary | Lens Centration | Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered. (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior | Posted | Number | eyes | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Lens Centration | Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered. (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior | Posted | Number | eyes | 1 week | Eyes | Eyes |
|
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| Secondary | Post-blink Movement | Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps) | Posted | Mean | Standard Deviation | mm steps | Baseline and 1 week |
|
|
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| Secondary | Lens Tightness | Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement. | Posted | Mean | Standard Deviation | percentage of tightness | Baseline and 1 week |
|
|
|
| Secondary | Visual Quality | Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
|
| Secondary | Ease of Lens Insertion | Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
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| Secondary | Ease of Lens Removal | Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
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| Secondary | Overall Lens Fit | Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);
| Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
|
| Secondary | Bulbar Hyperemia | Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
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| Secondary | Limbal Hyperemia | Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Secondary | Corneal Dehydration Staining | Corneal Staining: Dehydration Staining: Yes/No | Posted | Number | participants | 1 week |
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| Secondary | Corneal Staining (Extent) | Corneal staining extent, grade as % of each zone: C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior | Posted | Mean | Standard Deviation | percentage of cornea | Baseline and 1 week |
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| Secondary | Conjunctival Indentation | Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week. |
|
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| Secondary | Conjunctival Staining | Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Enfilcon A Lens (Control) | Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens | 0 | 40 | 0 | 40 |
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| Overall dryness at 1 week |
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| Other |
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| Other |
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| Baseline, Nick |
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| 1 week, Blue specs |
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| 1 week, Nick |
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| 1 week, Particles |
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| T |
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| S |
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| I |
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| N/S |
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| N/I |
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| T/S |
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| T/I |
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| T |
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| S |
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| I |
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| N/S |
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| N/I |
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| T/S |
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| T/I |
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| Overall vision quality at 1 week |
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| Nasal - baseline |
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| Nasal - 1 week |
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| Temporal - baseline |
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| Temporal - 1 week |
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| Superior - baseline |
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| Superior - 1 week |
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| Inferior - baseline |
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| Inferior - 1 week |
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| Temporal - baseline |
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| Temporal - 1 week |
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| Superior - baseline |
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| Superior - 1 week |
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| Inferior - baseline |
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| Inferior - 1 week |
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| Temporal - baseline |
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| Temporal - 1 week |
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| Superior - baseline |
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| Superior - 1 week |
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| Inferior - baseline |
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| Inferior - 1 week |
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