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The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 109182 | Experimental | Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours |
|
| Opti-Free Plus | Active Comparator | Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 109182 | Device | Investigational multipurpose contact lens cleaning and disinfecting solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein | The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage. | Day 1, after 2 hours of wear |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein | The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsunemitsu Senta | Alcon Japan, Ltd. | Study Director |
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Of the 36 subjects enrolled in the study, 8 were exited prior to product exposure [did not meet eligibility criteria (5), and subject withdrawal (3)]. This reporting group includes all subjects who used the study products (28).
Subjects were enrolled from one study site located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | FID 109182/Opti-Free Plus | Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all subjects who used the study products.
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| ID | Title | Description |
|---|---|---|
| BG000 | FID 109182/Opti-Free Plus | Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours. |
| 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 | Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein | The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage. | This analysis population includes all subjects who used the study products and had examination/observation data after use. | Posted | Number | percentage of participants | Day 1, after 2 hours of wear |
|
Adverse events were collected for the duration of the study.
This analysis population includes all subjects who used the study products. In this contralateral study, number at risk is presented by eye.
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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 | FID 109182 | Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical & Regulatory Affairs, Division of Medical Affairs | Alcon Japan, Ltd. | alcon.medinfo@alcon.com |
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| Opti-Free Plus | Device | Commercially available multipurpose contact lens cleaning and disinfecting solution |
|
|
| Senofilcon A contact lens | Device | Commercially available silicone hydrogel contact lens |
|
|
| Day 1, after 2 hours of wear |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Opti-Free Plus |
Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours |
|
|
| Secondary | Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein | The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage. | This analysis population includes all subjects who used the study products and had examination/observation data after use. | Posted | Number | percentage of participants | Day 1, after 2 hours of wear |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Opti-Free Plus | Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours | 0 | 28 | 0 | 28 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.