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The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.
This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A | Experimental | Participants wear comfilcon A lens for 4 weeks during the cross over study. |
|
| lotrafilcon B | Active Comparator | Participants wear lotrafilcon B lens for 4 weeks during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | contact lens |
| |
| lotrafilcon B |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses. | Baseline, 2 weeks, 4 weeks |
| Comfort During the Day | Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses. | Days 3, 12, 26 |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following will render a subject ineligible for inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Graeme Young | Visioncare Research Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eyesite | Reading | Berkshire | RG1 1EX | United Kingdom | ||
| Brock and Houlford |
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Four subjects were not dispensed lenses due to screen failure. Seven subjects discontinued from the study due to the investigational site withdrawing from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A, Then Lotrafilcon B | Participants wear comfilcon A lens, then lotrafilcon B for 4 weeks during the cross over study. comfilcon A: contact lens lotrafilcon B: contact lens |
| FG001 | Lotrafilcon B, Then Comfilcon A | Participants wear lotrafilcon B lens, then comfilcon A lens for 4 weeks during the cross over study. lotrafilcon B: contact lens comfilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
|
| |||||||||||||||||||||
| Second Intervention (4 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants wear comfilcon A and lotrafilcon B lens for 4 weeks during the cross over study. comfilcon A: contact lens lotrafilcon B: contact lens |
| 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 | Comfort | Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 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 | Comfilcon A | Participants wear comfilcon A lens for 4 weeks during the cross over study. comfilcon A: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Global Medical Scientific Affairs | CooperVision Inc. | 925 621-3761 | javega@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 |
|
| Chew Magna |
| Bristol |
| BS40 8PR |
| United Kingdom |
| Tempany's Boutique Opticians | Broadstone | Dorset | BH18 8DP | United Kingdom |
| Chalmers Opticians | Cardiff | Glamorgan | CF24 3RQ | United Kingdom |
| Leightons | St Albans | Hertfordshire | AL1 3LH | United Kingdom |
| David Gould Opticians | Rawtenstall | Lancashire | BB4 7QN | United Kingdom |
| Harrold Opticians | Uxbridge | Middlesex | UB8 1JX | United Kingdom |
| Boots Opticians Ltd | Birmingham | Warwickshire | B4 7TB | United Kingdom |
| Visioncare Research Ltd. | Farnham | GU9 7EN | United Kingdom |
| Poor fitting characteristics |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants wear lotrafilcon B lens for 4 weeks during the cross over study. lotrafilcon B: contact lens |
| OG003 | Comfilcon A (4 Weeks) | Participants wear comfilcon A lens for 4 weeks during the cross over study. comfilcon A: contact lens |
| OG004 | Lotrafilcon B (4 Weeks) | Participants wear lotrafilcon B lens for 4 weeks during the cross over study. lotrafilcon B: contact lens |
|
|
| Primary | Comfort During the Day | Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses. | Missing data from one participant. | Posted | Mean | Standard Deviation | units on a scale | Days 3, 12, 26 |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Lotrafilcon B | Participants wear lotrafilcon B lens for 4 weeks during the cross over study. lotrafilcon B: contact lens | 0 | 74 | 0 | 74 | 0 | 74 |
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| 12:00 pm |
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| 4:00 pm |
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| 8:00 pm |
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