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This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of ~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A (1-Day) and etafilcon A (Reusable) | Experimental | Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
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| etafilcon A (1-Day) and Investigational Lens 1 | Experimental | Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
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| etafilcon A (1-Day) and Investigational Lens 2 | Experimental | Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
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| etafilcon A (1-Day) and Investigational Lens 3 | Experimental | Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Lens 1 | Device | One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) | The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Score | Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE 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. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Foundation, Sankara Nethralaya | Chennai | 600 006 | India |
A total of 26 subjects were discontinued from the adaptation period. A total of 142 subjects were enrolled into the extended wear period. Of the enrolled subjects, all 142 were dispensed a study lens. Of the dispensed subjects in the extended wear period 58 completed the study and 84 subjects discontinued from the study.
This study utilized an adaptation period of 14 days prior to dispensing the extended wear contact lenses. A total of 171 subjects were enrolled into the adaption period. Of those enrolled into this period 168 were dispensed a study lens and 3 did not meet the eligibility criteria. Of the 168 dispensed subjects 142 completed the adaptation period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Lens 1 | Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period. |
| FG001 | Investigational Lens 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Adaptation Period |
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| Investigational Lens 2 | Device | One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
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| Investigational Lens 3 | Device | One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
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| etafilcon A (Reusable) | Device | One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear. |
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| etafilcon A (1-Day) | Device | 2-week contact lens adaptation period wearing prior to randomization |
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| Time Frame Up to 6 months |
| Overall Vision Score | Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE 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. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation. | Time Frame Up to 6 months |
Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
| FG002 | Investigational Lens 3 | Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period. |
| FG003 | Etafilcon A (Resuable) | Subjects that were randomized to receive the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period. |
| FG004 | Etafilcon A (1-Day) | All subjects wore the etafilcon A 1-Day contact lens during the 2-week adaptation period. |
| COMPLETED | 142 |
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| NOT COMPLETED |
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| Extended Wear Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Dispensed Subjects | All subjects dispensed at least 1 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 | All subjects enrolled into the adaptation or extended wear period of the study. | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | All subjects enrolled into the adaptation or extended wear period of the study. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | All subjects that were enrolled into the adaptation or extended wear period of the study. | Number | 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 | |||||||||||||||||||||||||||||
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| Primary | Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) | The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type. | The analysis population consists of all subjects that were enrolled into the extended wear period. | Posted | Number | Number of Events | Up to 6 months | Eyes | Eyes |
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| Secondary | Overall Comfort Score | Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE 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. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation. | The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods. | Posted | Mean | Standard Deviation | Units on a Scale | Time Frame Up to 6 months |
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| Secondary | Overall Vision Score | Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE 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. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation. | The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods. | Posted | Mean | Standard Deviation | Units on a Scale | Time Frame Up to 6 months |
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Throughout the entire duration of the study. Approximately 6 months 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 | Etafilcon A (1-Day) | All subject wore the etafilcon A (1-Day) contact lens throughout the entire duration of the adaptation period (14-Days). | 0 | 168 | 0 | 168 | 12 | 168 |
| EG001 | Investigational Lens 1 | Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period. | 0 | 36 | 0 | 36 | 36 | 36 |
| EG002 | Investigational Lens 2 | Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period. | 0 | 35 | 0 | 35 | 27 | 35 |
| EG003 | Investigational Lens 3 | Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period. | 0 | 36 | 3 | 36 | 33 | 36 |
| EG004 | Etafilcon A (Resuable) | Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period. | 0 | 35 | 1 | 35 | 22 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iritis | Eye disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Immune system disorders | Systematic Assessment |
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| CLPC (Contact Lens Papillary Conjunctivitis) | Eye disorders | Systematic Assessment |
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| Meibomianitis | Eye disorders | Systematic Assessment |
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| NSIE (Non-significant Infiltrative Event) | Eye disorders | Systematic Assessment |
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| Corneal Foreign Body | Eye disorders | Systematic Assessment |
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| Slit Lamp Findings Grade 2 or less requiring treatment | Eye disorders | Systematic Assessment |
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| SPK (Superficial Punctate Keratitis) | Eye disorders | Systematic Assessment |
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| Symptoms Problems or Complaints Requiring Treatment | Eye disorders | Systematic Assessment |
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| CLPU (Contact Lens induced Peripheral Ulcer) | Eye disorders | Systematic Assessment |
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| Asymptomatic Corneal Scar | Eye disorders | Systematic Assessment |
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| SIE (Significant Infiltrative Event) | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Dow -PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision | 904-443-1061 | edow1@its.jnj.com |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Missed too many scheduled visits |
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| Unsatisfactory Lens Fitting |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Eyes |
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Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period. |
| OG003 | Etafilcon A (Resuable) | Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period. |
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Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period. |
| OG003 | Etafilcon A (Resuable) | Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period. |
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