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| ID | Type | Description | Link |
|---|---|---|---|
| PRO-518 |
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| Name | Class |
|---|---|
| Singapore Polytechnic University | UNKNOWN |
| Visioncare Research Ltd. | OTHER |
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This study seeks to evaluate the clinical performance of two daily disposable contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A / ocufilcon D | Other | etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable |
|
| oculfilcon D / etafilcon A | Other | ocufilcon D contact lens worn first, etafilcon A contact lens worn second |
|
| ocufilcon D / ocufilcon D | Other | ocufilcon D contact lens worn first and second |
|
| etafilcon A / etafilcon A | Other | etafilcon A contact lens worn first and second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | daily disposable contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Comfort | Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0) | 1-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort Throughout the Whole Day | Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat". | 1-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort While Working on Computer | Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat". | 1-week-follow-up |
Inclusion Criteria:
Be between 21 and 39 years of age.
Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
Require a visual correction in both eyes (monovision allowed but no monofit).
Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
Astigmatism of 1.00D or less in both eyes.
Be able to wear the lens powers available for this study.
Be correctable to a visual acuity of 20/30 or better in each eye.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore | Singapore |
There were 50 patients enrolled and randomized, and 50 patients completed the study.
There were 50 subjects enrolled in this single site study, located at Singapore University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A First, Then Ocufilcon D | etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second |
| FG001 | Ocufilcon D First, Then Etafilcon A | ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second. |
| FG002 | Etafilcon A First, Then Etafilcon A | etafilcon A contact lenses worn for both periods. |
| FG003 | Ocufilcon D First, Then Ocufilcon D | Ocufilcon D contact lenses worn for both periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Fit) |
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| Period 2 (Follow-up) |
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| Period 3 (Fit) |
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| Period 4 (Follow-up) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Total number of completed participants are included in baseline measurements. |
| 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 | Lens Comfort | Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0) | Subjects analyzed were those who were enrolled, randomized, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | 1-week follow-up |
|
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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 | Etafilcon A/ Ocufilcon D | etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second |
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The integrity of the subject reported data is suspect and not reflective of lens' performance due to a significant protocol deviation. Upon completion of the study it was found that subjects were unmasked and their data should be considered biased.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody OD, FAAO | Vistakon | 904-443-3088 |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ocufilcon D | Device | daily disposable contact lens |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Comfort Throughout the Whole Day | Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat". | Subjects analyzed were those enrolled, randomized, and completed the study. | Posted | Number | percentage of participants | 1-week follow-up |
|
|
|
| Other Pre-specified | Comfort While Working on Computer | Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat". | Posted | Number | percentage of participants | 1-week-follow-up |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Ocufilcon D / Etafilcon A | ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second. | 0 | 13 | 0 | 13 |
| EG002 | Etafilcon A/ Etafilcon A | etafilcon A contact lenses worn first and second period. | 0 | 13 | 0 | 13 |
| EG003 | Oculfilcon D / Ocufilcon D | ocufilcon D contact lenses worn first and second period. | 0 | 12 | 0 | 12 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.