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This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL | Experimental | Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence. |
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| CONTROL/TEST | Experimental | Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A with novel molding process | Device | TEST Lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Scores | Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft 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), where higher scores indicate a more favorable/positive response with a range of 0-120. | 1-week Follow-up |
| Overall Vision Scores | Overall vision was assessed using the CLUE questionnaire. CLUE is a validated PRO questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using IRT 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. | 1-week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Wear Time | Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type. | 1-week Follow-up |
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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.
Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
The subject must have normal eyes (i.e., no ocular medications or infections of any type).
The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
The subject's refractive cylinder must be < 0.75 D in each eye.
The subject must have best corrected visual acuity of 20/25 or better in each eye.
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 |
|---|---|---|---|---|---|---|
| EyeCenter Optometrics | Rocklin | California | 95677 | United States | ||
| Fleming Island Vision Center |
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A total of 268 subjects were enrolled in this study. Of those enrolled, 263 dispensed at least one study lens while, 5 subjects failed to meet all eligibility criteria. Of those dispensed subjects, 252 subjects completed the study while, 11 subjects were discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period. |
| FG001 | Control/Test | Subjects randomized to receive the Control lens during the first period and then receive the Test lens during the second period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2018 |
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| etafilcon A with current molding process |
| Device |
CONTROL Lens |
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| LLHC LogMAR Visual Performance | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type. | 1-week Follow-up |
| HLLC LogMAR Visual Performance | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type. | 1-week Follow-up |
| Fleming Island |
| Florida |
| 32258 |
| United States |
| Bartram Eye Clinic | Jacksonville | Florida | 32258 | United States |
| Sabal Eye Care | Longwood | Florida | 32779 | United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| St. Johns Eye Associates | Saint Augustine | Florida | 32092 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Eyecare Professionals of Powell | Powell | Ohio | 43065 | United States |
| Primary Eyecare Group | Brentwood | Tennessee | 37027 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Boutetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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All subjects dispensed in a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subject | All subjects dispensed a study lens. |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Overall Comfort Scores | Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft 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), where higher scores indicate a more favorable/positive response with a range of 0-120. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | unit on a scale | 1-week Follow-up |
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| Primary | Overall Vision Scores | Overall vision was assessed using the CLUE questionnaire. CLUE is a validated PRO questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using IRT 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. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | unit on a scale | 1-week Follow-up |
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| Secondary | Average Daily Wear Time | Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Hours | 1-week Follow-up |
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| Secondary | LLHC LogMAR Visual Performance | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 1-week Follow-up | eyes | eyes |
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| Secondary | HLLC LogMAR Visual Performance | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 1-week Follow-up | eyes | eyes |
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Throughout the duration of the study, approximately 2 weeks 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 | Test | Subjects that wore the Test lens in either the first or second period of the study. | 0 | 263 | 0 | 263 | 0 | 263 |
| EG001 | Control | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 263 | 0 | 263 | 0 | 263 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, OD, MS, FAAO - Director | Johnson & Johnson Vision Care, Inc | 1-904-629-2289 | BPALL@its.jnj.com |
| Mar 18, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| eyes |
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