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| Name | Class |
|---|---|
| NOVARTIS BIOCIENCIAS S/A | UNKNOWN |
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The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane | Experimental | Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane® Lid Wipes | Other | Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Contact-dermatitis Adverse Reaction | Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis. | Day 21 |
| Number of Participants With Ocular Clinical Signs and Discomfort Sensations | Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis. | Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alcon Brazil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Biociencias SA | São Paulo | 04636-000 | Brazil |
Thirty-five participants were enrolled in this study. This reporting group includes all enrolled participants (35).
Participants were recruited from 1 study center located in Brazil.
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane | Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Systane | Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants With a Contact-dermatitis Adverse Reaction | Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis. | This analysis population includes all enrolled participants. | Posted | Number | participants | Day 21 |
|
|
Adverse events (AEs) were collected for the duration of participation in the study (up to 21 days). This analysis group includes all enrolled participants. Ocular AEs are presented for both study eye and non-study eye combined.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a product and that does not necessarily have a causal relationship with this treatment. All AEs were obtained as solicited and spontaneous comments from the study participants and through regular investigator assessment throughout the 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 | Systane | Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dir Clinical Operations - LACAR, GCRA | Alcon, a Novartis company | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
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| Primary | Number of Participants With Ocular Clinical Signs and Discomfort Sensations | Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis. | This analysis population includes all enrolled participants. | Posted | Number | participants | Day 21 |
|
|
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| 0 |
| 35 |
| 0 |
| 35 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.