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This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1 | Experimental | Eligible subjects will be randomized to the TEST lens to wear in both eyes for approximately 2 weeks. |
|
| ARM 2 | Experimental | Eligible subjects will be randomized to the CONTROL lens to wear in both eyes for approximately 2 weeks. Then the subject will receive the TEST lens to wear in both eyes for approximately 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE Oasys 1-Day | Device | TEST |
| |
| Habitual Lens |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Comfort Score | 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. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance. | Up to 2-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline CLDEQ-8 Score | The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The change is calculated as 2-week minus Baseline. The change from baseline CLDEQ-8 score ranges from -30 to 30 where lower change from baseline CLDEQ-8 scores indicate better performance. The average change in CLDEQ-8 for each arm was reported. |
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Inclusion Criteria:
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
11. Have spherical 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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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| Sabal Eye Care |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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A total of 95 subjects were enrolled in this study. Of those enrolled, 47 were randomized to Arm1 and dispensed at least one study lens, while 45 subjects were randomized to Arm 2 and were dispensed at least 1 study lenses. All dispensed subjects in Arm 1 completed the study while only 39 of those dispensed in Arm 2 completed the study. A total of 6 subjects were discontinued from Arm 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 2 | Subjects randomized to this Arm were dispensed their habitual lenses A for approximately 2 weeks, then returned for follow-up evaluation. Subjects were then dispensed senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study. |
| FG001 | Arm 1 | Subjects randomized to this Arm were dispensed the senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All subjects dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Subjects randomized to this Arm were dispensed the senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study. |
| BG001 | Arm 2 |
| 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 | Change From Baseline Comfort Score | 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. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance. | Subjects that completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint. | Posted | Mean | Standard Deviation | Units on a scale | Up to 2-Week Follow-up |
|
Throughout the entire duration of the study. For subject in Arm 1 their study duration was approximately 2-weeks while subjects in Arm 2 study duration was approximately 1-month.
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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 | Subjects that wore the senofilcon A lens in either Arm of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid - 19 | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R. Buch, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. | 1-800-846-2020 | jbuch@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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2021 | Aug 8, 2022 | Prot_SAP_000.pdf |
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| Device |
Subjects' own Habitual Lenses |
|
|
| Up to 2-Week Follow-up |
| Comfort Score | 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. The average comfort score was reported for each group within Arm 2 only. | 2-Week Follow-up |
| CLDEQ-8 Score | The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The average CLDEQ-8 for each arm was reported. | 2-Week Follow-up |
| Longwood |
| Florida |
| 32792 |
| United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Procare Vision Centers | Granville | Ohio | 43023 | United States |
| Dr. David Ferris & Associates | Warwick | Rhode Island | 02888 | United States |
| Optometry Group Pllc | Memphis | Tennessee | 38111 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| NOT COMPLETED |
|
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Subjects randomized to this Arm were dispensed their habitual lenses A for approximately 2 weeks, then returned for follow-up evaluation. Subjects were then dispensed senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| OG000 |
| Arm 1 |
Subjects that wore the senofilcon A lens for 2-weeks and then exited the study. |
| OG001 | Arm 2 (Subjects' Own Contact Lens) | Subjects that wore their habitual lenses for 2-weeks and then wore senofilcon A for 2-weeks and then exited the study. |
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|
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| Secondary | Change From Baseline CLDEQ-8 Score | The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The change is calculated as 2-week minus Baseline. The change from baseline CLDEQ-8 score ranges from -30 to 30 where lower change from baseline CLDEQ-8 scores indicate better performance. The average change in CLDEQ-8 for each arm was reported. | Subjects that completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint. | Posted | Mean | Standard Deviation | Unit on a scale | Up to 2-Week Follow-up |
|
|
|
|
| Secondary | Comfort Score | 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. The average comfort score was reported for each group within Arm 2 only. | Subjects randomized to Arm 2 and completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint. | Posted | Mean | Standard Deviation | Unit on a scale | 2-Week Follow-up |
|
|
|
|
| Secondary | CLDEQ-8 Score | The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The average CLDEQ-8 for each arm was reported. | Subjects randomized to Arm 2 and completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint. | Posted | Mean | Standard Deviation | Unit on a scale | 2-Week Follow-up |
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| 0 |
| 88 |
| 0 |
| 88 |
| 0 |
| 88 |
| EG001 | Nelfilcon A | Subjects that wore the nelfilcon A lens during the first period in Arm 2 | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Delfilcon A | Subjects that wore the delfilcon A lens during the first period in Arm 2 | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Somofilcon A | Subjects that wore the somofilcon A lens during the first period in Arm 2 | 0 | 5 | 0 | 5 | 0 | 5 |
| EG004 | Stenofilcon A | Subjects that wore the stenofilcon A lens during the first period in Arm 2 | 0 | 2 | 0 | 2 | 1 | 2 |
| EG005 | Etafilcon A | Subjects that wore the etafilcon A lens during the first period in Arm 2 | 0 | 17 | 0 | 17 | 0 | 17 |
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