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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narafilcon B Contact Lens | Experimental | Investigational Silicone Hydrogel Contact Lens |
|
| Spectacles | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narafilcon B Contact Lens | Device |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Papillary Conjunctivitis | Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year |
| Conjunctival Hyperemia | Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year |
| Limbal Hyperemia | Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year |
| Corneal Staining | Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. | 1 Year |
| Conjunctival Staining | Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. |
| Measure | Description | Time Frame |
|---|---|---|
| Comfortable Wearing Time | Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit. | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
Of the 59 identified as ineligible prior to group assignment, the majority were due to having a preexisting astigmatism.
There were 157 subjects consented to participate in this study. Fifty-nine (59) subjects were determined to be ineligible. This allotted forty-nine (49) subjects randomly to each study arm for a total of 98 subjects enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Silicone Hydrogel Contact Lens | Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment. |
| FG001 | Spectacles | Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline and Dispensed |
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| 2-Week Visit |
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| 1-Month Visit |
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| 3-Month Visit |
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| 6-Month Visit |
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| 1-Year Visit |
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Baseline participants were those who were randomly assigned to a study arm and started the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Silicone Hydrogel Contact Lens | Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group. |
| BG001 | Spectacles |
| 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, Categorical | Count of Participants |
| 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 | Papillary Conjunctivitis | Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 1 Year |
|
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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 | Investigational Silicone Hydrogel Contact Lens | Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine E. Osborn | Vistakon | clinicalstudies@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Spectacles |
| Device |
spectacle wearers |
|
| 1 Year |
| Corneal Neovascularization | New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | 1 Year |
| Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire | The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported. | 1 Year |
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| NOT COMPLETED |
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Subjects are randomized to this Control Group.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Spectacles | Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers. |
|
|
| Primary | Conjunctival Hyperemia | Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 1 Year |
|
|
|
| Primary | Limbal Hyperemia | Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 1 Year |
|
|
|
| Primary | Corneal Staining | Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. | Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | Efron Scale (0.1 Unit increments) | 1 Year |
|
|
|
| Primary | Conjunctival Staining | Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 1 Year |
|
|
|
| Primary | Corneal Neovascularization | New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. | Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 1 Year |
|
|
|
| Primary | Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire | The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported. | Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 1 Year |
|
|
|
| Secondary | Comfortable Wearing Time | Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit. | Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | Hours | 1 Year |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Spectacles | Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers. | 0 | 49 | 0 | 49 |
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