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The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.
Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTAL30, then AOHP | Other | Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
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| AOHP, then TOTAL30 | Other | Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A contact lenses | Device | CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use |
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| Measure | Description | Time Frame |
|---|---|---|
| Distance VA (logMAR) With Study Lenses | Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period) |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PL | United Kingdom |
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This reporting group includes all enrolled subjects/eyes.
Participants were recruited from one investigative site located in the United Kingdom.
| ID | Title | Description |
|---|---|---|
| FG000 | TOTAL30, Then AOHP | Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses were worn for approximately 28 days. The senofilcon A contact lenses were worn for approximately 14 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
| FG001 | AOHP, Then TOTAL30 | Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses were worn for approximately 14 days. The lehfilcon A contact lenses were worn for approximately 28 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period, Day 14 or Day 28 |
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| Second Wear Period, Day 14 or Day 28 |
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This analysis population includes all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | TOTAL30, Then AOHP | Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses were worn for approximately 28 days. The senofilcon A contact lenses were worn for approximately 14 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
| 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 | Distance VA (logMAR) With Study Lenses | Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | Safety analysis set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing responses. | Posted | Mean | Standard Deviation | logMAR | Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period) | eyes | eyes |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 1.5 months.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.
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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 | Pretreatment | Events reported in this group occurred prior to dispense of the study contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.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 | Dec 2, 2021 | May 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2022 | May 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Senofilcon A contact lenses | Device | CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use |
|
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| AOSEPT PLUS with HydraGlyde | Device | Hydrogen peroxide-based cleaning and disinfecting solution |
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| NOT COMPLETED |
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| BG001 | AOHP, Then TOTAL30 | Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses were worn for approximately 14 days. The lehfilcon A contact lenses were worn for approximately 28 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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Lehfilcon A contact lenses worn in Period One or Period 2, as randomized. The lenses were worn for approximately 28 days bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
| OG001 | AOHP | Senofilcon A contact lenses worn in Period One or Period 2, as randomized. The lenses were worn for approximately 14 days bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
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|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | TOTAL30 Ocular | Events reported in this group occurred following dispense of the lehfilcon A contact lenses | 0 | 68 | 0 | 68 | 0 | 68 |
| EG002 | TOTAL30 Non-ocular | Events reported in this group occurred following dispense of the lehfilcon A contact lenses | 0 | 34 | 0 | 34 | 0 | 34 |
| EG003 | AOHP Ocular | Events reported in this group occurred following dispense of the senofilcon A contact lenses | 0 | 70 | 0 | 70 | 0 | 70 |
| EG004 | AOHP Non-ocular | Events reported in this group occurred following dispense of the senofilcon A contact lenses | 0 | 35 | 0 | 35 | 0 | 35 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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