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This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).
This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methafilcon A IV | Active Comparator | Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study. |
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| Ocufilcon B | Active Comparator | Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study. |
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| Omafilcon A | Active Comparator | Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methafilcon A IV | Device | Contact Lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity Using logMAR | Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
| Lens Fit - Horizontal Centration | Assessment of horizontal centration of lens on eye | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
| Lens Fit - Vertical Centration | Assessment of vertical centration of lens on eye | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
| Lens Fit - Corneal Coverage of Lens | Assessment of corneal coverage of lens on eye | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
| Lens Fit - Movement of Lens | Assessment of movement of lens on eye | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research - The University of Manchester | Manchester | M13 9PL | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methafilcon A IV, Ocufilcon B, Omafilcon A | Subjects randomized to wear Methafilcon A IV first, then Ocufilcon B, then Omafilcon A contact lens |
| FG001 | Methafilcon A IV, Omafilcon A, Ocufilcon B | Subjects randomized to wear Methafilcon A IV first, then Omafilcon A, then Ocufilcon B contact lens |
| FG002 | Ocufilcon B, Omafilcon A, Methafilcon A IV | Subjects randomized to wear Ocufilcon B first, then Omafilcon A, then Methafilcon A IV contact lens |
| FG003 | Ocufilcon B, Methafilcon A IV, Omafilcon A | Subjects randomized to wear Ocufilcon B first, then Methafilcon A IV, then Omafilcon A contact lens |
| FG004 | Omafilcon A, Ocufilcon B, Methafilcon A IV | Subjects randomized to wear Omafilcon A first, then Ocufilcon B, then Methafilcon A IV contact lens |
| FG005 | Omafilcon A, Methafilcon A IV, Ocufilcon B | Subjects randomized to wear Omafilcon A first, then Methafilcon A IV, then Ocufilcon B contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Hour, Visit 2) |
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| Second Intervention (1 Hour, Visit 4) |
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| Third Intervention ( 1 Hour, Visit 6) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants were randomized to wear each of the 3 different contact lens pairs |
| Units | Counts |
|---|---|
| Participants |
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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 | Visual Acuity Using logMAR | Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction | Posted | Mean | Standard Deviation | logMAR | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
|
Patients wore 3 different contact lenses for 1 hour on 3 different days
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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 | Omafilcon A | Subjects who wore Omafilcon A for 1 hour during the cross over study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, O.D., MSc., FAAO | CooperVision | 9256213761 | javega@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2017 | Aug 27, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Ocufilcon B |
| Device |
Contact Lens |
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| Omafilcon A | Device | Contact Lens |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| 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 |
|
Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study. |
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| Primary | Lens Fit - Horizontal Centration | Assessment of horizontal centration of lens on eye | Posted | Count of Participants | Participants | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
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|
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| Primary | Lens Fit - Vertical Centration | Assessment of vertical centration of lens on eye | Posted | Count of Participants | Participants | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
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|
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| Primary | Lens Fit - Corneal Coverage of Lens | Assessment of corneal coverage of lens on eye | Posted | Count of Participants | Participants | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
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|
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| Primary | Lens Fit - Movement of Lens | Assessment of movement of lens on eye | Posted | Count of Participants | Participants | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn |
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|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Methafilcon A IV | Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study. | 0 | 39 | 0 | 39 | 0 | 39 |
| EG002 | Ocufilcon B | Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study. | 0 | 39 | 0 | 39 | 0 | 39 |
Disclosure restriction on the PI is that the sponsor should be notified of any use of data for results communication.
| Optimum |
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| Slightly temporal |
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| Extremely temporal |
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| At follow up |
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| Optimum |
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| Slightly superior |
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| Extremely superior |
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| At follow up |
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| Optimum |
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| Slightly excessive |
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| Extremely excessive |
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| At follow up |
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| Optimum |
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| Slightly excessive |
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| Extremely excessive |
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| At follow up |
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