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This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.
This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somofilcon A | Active Comparator | Subjects are randomized to wear somofilcon A for one week during the cross over study. |
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| nelfilcon A II 2 | Active Comparator | Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. |
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| omafilcon A ll 2 | Active Comparator | Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A | Device | contact lens |
| |
| nelfilcon A II 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Physiology | Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit - Horizontal Centration | Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal. | 1 week |
| Lens Fit - Vertical Centration |
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Inclusion Criteria:
Subjects will only be eligible for the study if:
Exclusion Criteria:
Subjects will not be eligible to take part in the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Maldonado-Codinal, PhD, FAAO | Eurolens Research, University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research - The University of Manchester | Manchester | M13 9PL | United Kingdom |
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Subjects are randomized to wear each lens brand for one week in a random sequence.
55 subjects were recruited for the study, 51 subjects were enrolled and 50 subjects completed the initial follow up visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2 | Subjects are randomized to wear somofilcon A pair of lenses for one week during the crossover study then nelfilcon A II2, then omafilcon A II 2 lenses for one week each. |
| FG001 | Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2 | Subjects are randomized to wear somofilcon A pair of lenses for one week during the cross-over study then omafilcon A II 2, then nelfilcon A II 2 lenses for one week each. |
| FG002 | Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2 | Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then Omafilcon A II 2 lenses for one week each. |
| FG003 | Nelfilcon A II 2, Omafilcon A II 2, Somofilcon A | Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Omafilcon A II 2, then Somofilcon A, lenses for one week each. |
| FG004 | Omafilcon A II 2, Nelficon A II 2, Somofilcon A | Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then nelfilcon A II 2, then Somofilcon A lenses for one week each. |
| FG005 | Omafilcon A II 2, Somofilcon A, Nelfilcon A II 2 | Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then nelfilcon A II 2 lenses for one week each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dispense 1 |
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| Dispense 2 |
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| Dispense 3 |
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55 subjects were recruited for the study with 50 subjects completing initial follow up visit. 5 subjects were ineligible to be dispensed with lenses for sphere out of range or cylinder out of range.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total participants |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Ocular Physiology | Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Protocol deviations and discontinuations account for difference in analysis population | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
Subjects were randomized to wear each pair of lenses (Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2 at a random sequence) for One- Week in a random sequence, assessed overall for up to 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 | Somofilcon A | Subjects are randomized to wear Somofilcon A for one week at random sequence |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | Infections and infestations | Systematic Assessment | Non-ocular adverse events reported during the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, O.D., MSc., FAAO | CooperVision Inc. | 9256213761 | jvega2@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
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| omafilcon A ll 2 | Device | contact lens |
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Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
| 1 week |
| Lens Fit - Corneal Coverage | Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal. | 1 week |
| Lens Fit - Movement | Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive. | 1 week |
| Lens Surface - Deposition | Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe | 1 week |
| Lens Surface - Wettability | Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe | 1 week |
| Visual Acuity | Visual acuity will be assessed by LogMAR. | 1 week |
| 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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| OG002 |
| Omafilcon A ll 2 |
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens |
|
|
| Secondary | Lens Fit - Horizontal Centration | Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal. | Protocol deviations and discontinuations account for difference in analysis population | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Lens Fit - Vertical Centration | Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal. | Protocol deviations and discontinuations account for difference in analysis population | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Lens Fit - Corneal Coverage | Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal. | Protocol deviations and discontinuations account for difference in analysis population | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Lens Fit - Movement | Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive. | Protocol deviations and discontinuations account for difference in analysis population | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Lens Surface - Deposition | Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe | Protocol deviations and discontinuations account for difference in analysis population | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Lens Surface - Wettability | Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe | Protocol deviations and discontinuations account for difference in analysis population | Posted | Count of Participants | Participants | 1 week |
|
|
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| Secondary | Visual Acuity | Visual acuity will be assessed by LogMAR. | Protocol deviations and discontinuations account for difference in analysis population | Posted | Mean | Standard Deviation | LogMAR | 1 week |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 4 |
| 49 |
| EG001 | Nelfilcon A II 2 | Subjects are randomized to wear Nelfilcon A II 2 for one week at random sequence | 0 | 48 | 0 | 48 | 3 | 48 |
| EG002 | Omafilcon A II 2 | Subjects are randomized to wear Omafilcon A II 2 for one week at random sequence | 0 | 49 | 0 | 49 | 4 | 49 |
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| Optimum |
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| Slightly Temporal |
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| Extremely Temporal |
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| Optimum |
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| Slightly Temporal |
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| Extremely Temporal |
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| Optimum |
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| Slightly Temporal |
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| Extremely Temporal |
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| Optimum |
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| Slightly excessive |
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| Extremely excessive |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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