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This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-Lens | Active Comparator | etafilcon A with ketotifen. Subjects between the ages of 18-40 will be randomized into the K-Lens arm and will be scheduled for a total of two study visits with approximately 6-9 days in between. |
|
| Placebo Contact Lens | Placebo Comparator | 1-Day Acuvue. Subjects between the ages of 18-40 will be randomized into the Placebo arm and will be scheduled for a total of two study visits with approximately 6-9 days in between. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A with ketotifen | Combination Product | Etafilcon A with ketotifen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) | Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit. | Baseline (Visit 1) and 1-week follow up (Visit 2) |
| Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) | Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit. | Baseline (Visit 1) and 1-week follow up (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Eyes With Clinically Significant Slit Lamp Findings | Slit lamp findings were assessed using a biomicroscope for each subject eye at all scheduled and unscheduled visits. Clinical significant slit lamp findings are defined as Grade 3 or Grade 4. (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate and Grade 4= Severe). The data was dichotomized as 1=Grade 3 or Grade 4 and 0, otherwise. The number of eyes with clinically significant slit lamp findings for each lens type was reported. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Between 18 and 39 (inclusive) years of age at the time of baseline visit.
The subject must be a habitual lens wearer for a least 6 days/week and for a minimum of 8 hours per day over the last month.
The subject's contact lens correction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
The subject's refractive cylinder must be 1.00 D or less in each eye.
Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye (Snellen Visual Acuity).
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| Maitland Vision Center |
A total of 143 subjects were enrolled into this study. Of those enrolled, 141 were dispensed a study lens and 2 subjects were enrolled but not dispensed. Of the dispensed subjects 140 completed the study and 1 discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A With Ketotifen | Subjects that were randomized to the etafilcon A with ketotifen contact lens throughout the entire duration of the study. |
| FG001 | Etafilcon A | Subjects that were randomized to the etafilcon A contact lens throughout the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etafilcon A With Ketotifen | Subjects that were randomized to the etafilcon A with ketotifen contact lens throughout the entire duration of the study. |
| BG001 | Etafilcon A | Subjects that were randomized to the etafilcon A contact lens throughout the entire duration 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 | Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) | Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit. | Per-protocol (PP) population which consists of all subjects who completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | Baseline (Visit 1) and 1-week follow up (Visit 2) | eyes | eyes |
|
Throughout the entire duration of the study. Approximately 1-Week per subject.
All subjects dispensed at least 1 study lens.
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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 With Ketotifen | Subjects that wore the etafilcon A with ketotifen contact lens throughout the entire duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall O.D, MS, FAAO | Johnson & Johnson Vision Care, Inc. | 1-800-843-2020 | bpall@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2017 | Feb 3, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2018 | Feb 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007665 | Ketotifen |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
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| 1-Day ACUVUE |
| Device |
1-Day ACUVUE |
|
| Up to 1-Week Follow-up |
| The Number of Eyes With Unacceptable Lens Fitting | Lens fit was assessed for each subject and eye using a biomicroscope. Unacceptable lens fit was assessed at all scheduled and unscheduled visits. A subject was deemed to have an unacceptable lens fitting if they met any of the following criteria: (1) Limbal exposure at primary gaze with extreme eye movement, (2) edge lift, (3) excessive movement in primary up gaze, (4) insufficient movement in all three of the following conditions: primary gaze, up gaze and push up test. The number of eyes with unacceptable lens fitting was reported for each lens type. | Up to 1-Week Follow-up |
| Maitland |
| Florida |
| 32751 |
| United States |
| St. Lucy's Vision Center | Tampa | Florida | 33625 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Etafilcon A |
Subjects that wore the etafilcon A contact lens throughout the entire duration of the study. |
|
|
|
| Primary | Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) | Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit. | Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article. | Posted | Mean | Standard Deviation | logMAR | Baseline (Visit 1) and 1-week follow up (Visit 2) | eyes | eyes |
|
|
|
|
| Secondary | The Number of Eyes With Clinically Significant Slit Lamp Findings | Slit lamp findings were assessed using a biomicroscope for each subject eye at all scheduled and unscheduled visits. Clinical significant slit lamp findings are defined as Grade 3 or Grade 4. (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate and Grade 4= Severe). The data was dichotomized as 1=Grade 3 or Grade 4 and 0, otherwise. The number of eyes with clinically significant slit lamp findings for each lens type was reported. | Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article. MITT is identical to safety population. | Posted | Number | Number of Eyes | Up to 1-Week Follow-up | eyes | eyes |
|
|
|
| Secondary | The Number of Eyes With Unacceptable Lens Fitting | Lens fit was assessed for each subject and eye using a biomicroscope. Unacceptable lens fit was assessed at all scheduled and unscheduled visits. A subject was deemed to have an unacceptable lens fitting if they met any of the following criteria: (1) Limbal exposure at primary gaze with extreme eye movement, (2) edge lift, (3) excessive movement in primary up gaze, (4) insufficient movement in all three of the following conditions: primary gaze, up gaze and push up test. The number of eyes with unacceptable lens fitting was reported for each lens type. | Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article. MITT is identical to safety population. | Posted | Number | eyes | Up to 1-Week Follow-up | Number of Eyes | Number of Eyes |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | Etafilcon A | Subjects that wore the etafilcon A contact lens throughout the entire duration of the study. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |