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The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control - Phase 1 | Experimental | Over visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner. |
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| Control/Test - Phase 1 | Experimental | Over visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner. |
|
| Test/Control - Phase 2 | Experimental | During Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner. |
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| Control/Test - Phase 2 | Experimental | During Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contact Lenses with 8.5 BC | Device | Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Subjective CLUE Comfort and Keratometry | CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported. | 3-day follow-up |
| Correlation Between Subjective CLUE Comfort and Corneal Diameter | Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter. | 3-day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | 32205 | United States | |||
A total of 72 subjects were enrolled into this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 71 were dispensed lenses. Of the dispensed subjects 45 completed both Phase I and II while 26 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control - Phase 1 | Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye. |
| FG001 | Control/Test - Phase 1 | Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye. |
| FG002 | Test/Control - Phase 2 | Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 8.5 Base Curve in both eyes and then wore narafilcon A lens with 9.0 Base Curve in both eyes. |
| FG003 | Control/Test - Phase 2 | Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I - Contralateral |
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| Phase II - Period 1 Bilateral |
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| Phase II - Period 2 Bilateral |
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All subjects that were dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed at least one study lens throughout the course of the study. |
| 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 | Correlation Between Subjective CLUE Comfort and Keratometry | CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Pearson Correlation | 3-day follow-up |
|
Throughout the duration of the study. Approximately 1-week per subject.
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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 | Narafilcon A- 8.5 Base Curve | Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Le, OD -Manager Global Medical Affairs | Johnson & Johnson Vision Care Inc. | 904 4431866 | ale3@ITS.JNJ.com |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Contact Lenses with 9.0 BC | Device | Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC. |
|
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Withdrawal by Subject |
|
| incorrect randomization |
|
| unsatisfactory lens fitting |
|
| 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 |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Narafilcon A- 8.5 Base Curve | Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II. |
| OG001 | Narafilcon A- 9.0 Base Curve | Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II. |
|
|
| Primary | Correlation Between Subjective CLUE Comfort and Corneal Diameter | Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Pearson Correlation | 3-day follow-up |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Narafilcon A- 9.0 Base Curve | Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II. | 0 | 71 | 0 | 71 |
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