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This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (TEST / CONTROL wear sequence) | Active Comparator | Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit. |
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| Group 2 (CONTROL / TEST wear sequence) | Active Comparator | Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEST Contact Lens | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall CLUE Comfort | Overall comfort was assessed using the Contact Lens User Experienceâ„¢ (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. | Up to 4-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall CLUE Handling | Overall Handling was assessed using the Contact Lens User Experienceâ„¢ (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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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A total of 200 subjects were enrolled into this study. Of the enrolled, 171 subjects were randomized and dispensed at least one study lens. Of the dispensed subjects, 127 completed the study while 44 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/Samfilcon A | All subjects that received the senofilcon A lens during the first period and the samfilcon A lens during the second period. |
| FG001 | Samfilcon A/Senofilcon A | All subjects that received the samfilcon A lens during the first period and the senofilcon A lens during the second period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | All subjects enrolled in the study, i.e. signed informed consent form. |
| 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 |
| 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 CLUE Comfort | Overall comfort was assessed using the Contact Lens User Experienceâ„¢ (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 that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | Up to 4-Week Follow-up |
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Throughout the entire duration of the study. Approximately 8 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 | Senofilcon A | All subjects that wore the senofilcon A lens during either the first or second period of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-significant Infiltrative Event | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chantal Coles-Brennan - PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care, Inc. | 1-904-443-3449 | CColesb@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 | Jul 17, 2017 | Sep 28, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2016 | Sep 28, 2018 | SAP_001.pdf |
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| CONTROL Contact Lens | Device |
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| Up to 4-Week Follow-up |
| Time to Haze | Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision. | Up to 4-Week Follow-up |
| Average Wear Time | Average lens wear time with the study lenses were recorded in hour at each follow-up visit. | Up to 4-Week Follow-up |
| Average Comfortable Wear Time | Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit. | Up to 4-Week Follow-up |
| Difference in Total Device Use Time and Comfortable Wear Time During Device Use | Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use. | Up to 4-Week Follow-up |
| Comfort at the End of the Day | Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type. | Up to 4-Week Follow-up |
| Protocol Violation |
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| Adverse Event |
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| Withdrawal by Subject |
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| Lens Discomfort |
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| NOT COMPLETED |
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| 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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| OG001 | Samfilcon A | All subjects that wore the samfilcon A lens during either the first or second period of the study. |
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| Secondary | Overall CLUE Handling | Overall Handling was assessed using the Contact Lens User Experienceâ„¢ (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 that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | Up to 4-Week Follow-up |
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| Secondary | Time to Haze | Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | seconds | Up to 4-Week Follow-up |
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| Secondary | Average Wear Time | Average lens wear time with the study lenses were recorded in hour at each follow-up visit. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Hours | Up to 4-Week Follow-up |
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| Secondary | Average Comfortable Wear Time | Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Hours | Up to 4-Week Follow-up |
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| Secondary | Difference in Total Device Use Time and Comfortable Wear Time During Device Use | Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Hours | Up to 4-Week Follow-up |
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| Secondary | Comfort at the End of the Day | Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | Up to 4-Week Follow-up |
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| 0 |
| 171 |
| 0 |
| 171 |
| 18 |
| 171 |
| EG001 | Samfilcon A | All subjects that wore the samfilcon A lens during either period of the study. | 0 | 171 | 0 | 171 | 29 | 171 |
| Non-significant Allergic Conjunctivitis | Eye disorders | Systematic Assessment |
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| Non-significant - Swollen Caruncle | Eye disorders | Systematic Assessment |
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| Non-significant Conjunctival Redness and Staining | Eye disorders | Systematic Assessment |
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| Non-significant Bulbar Redness | Eye disorders | Systematic Assessment |
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| Non-significant Grade 3-4 Conjunctival Staining | Eye disorders | Systematic Assessment |
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| Non-significant Symptoms, Problems or complaints requiring treatment | Eye disorders | Systematic Assessment |
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| Non-significant Bacterial Conjunctivitis | Eye disorders | Systematic Assessment |
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| Non-significant Keratoconjunctivitis | Eye disorders | Systematic Assessment |
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| Non-significant Limbal Nodules | Eye disorders | Systematic Assessment |
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| Non-significant Foreign Body | Eye disorders | Systematic Assessment |
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| Stye | Eye disorders | Systematic Assessment |
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| Non-significant Bulbar and Limbal Redness | Eye disorders | Systematic Assessment |
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| Non-significant Localized Allergic Reaction | Eye disorders | Systematic Assessment |
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| Non-significant Corneal Tissue Overgrowth | Eye disorders | Systematic Assessment |
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| Non-significant slit lamp finding Grade 2 or less requiring treatment | Eye disorders | Systematic Assessment |
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| Non-significant Conjunctival Redness Grade 3 or Higher | Eye disorders | Systematic Assessment |
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| Ear Infection | Ear and labyrinth disorders | Systematic Assessment |
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| Non-significant Reaction to Eye Drop | Eye disorders | Systematic Assessment |
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| Flu | Immune system disorders | Systematic Assessment |
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| Non-significant Phlyctenules | Eye disorders | Systematic Assessment |
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| Stomach Flu | Immune system disorders | Systematic Assessment |
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| Non-significant Superficial Deposits | Eye disorders | Systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Non-significant Blurred Central Vision | Eye disorders | Systematic Assessment |
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| Non-significant Superior Arcuate | Eye disorders | Systematic Assessment |
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| Non-significant Localized Corneal Staining | Eye disorders | Systematic Assessment |
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| Non-significant Ocular Discomfort | Eye disorders | Systematic Assessment |
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| Non-significant Redness | Eye disorders | Non-systematic Assessment | Patient Reported. |
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| Non-significant Difficulty opening eye | Eye disorders | Non-systematic Assessment |
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| Non-significant Stye | Eye disorders | Systematic Assessment |
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