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The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOHG toric, then AO toric | Other | Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. |
|
| AO toric, then AOHG toric | Other | Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B toric contact lenses with HYDRAGLYDE | Device | Silicone hydrogel soft contact lenses for astigmatism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) | Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint. | Day 1, 10 minutes after lens insertion, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon, A Novartis Division | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Johns Creek | Georgia | 30097 | United States |
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This reporting group includes all enrolled subjects (36).
Subjects were recruited from one investigative site located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AOHG Toric, Then AO Toric | Lotrafilcon B toric contact lenses with HYDRAGLYDE®, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. |
| FG001 | AO Toric, Then AOHG Toric | Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE®, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, FIrst 30 Minutes of Wear |
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| Period 2, Second 30 Minutes of Wear |
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This analysis population includes all randomized subjects exposed to any study lenses evaluated in this study (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Lotrafilcon B toric contact lenses with HYDRAGLYDE® and lotrafilcon B toric contact lenses worn during Period 1 and Period 2 in a crossover assignment |
| 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 | Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) | Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint. | Full Analysis Set | Posted | Number | percentage of lenses | Day 1, 10 minutes after lens insertion, each product | Eyes | Eyes |
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Dispense through study completion, approximately 2 hours
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the protocol. This analysis population includes all subjects/eyes exposed to any study lenses evaluated.
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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 | AOHG Toric | All subjects exposed to lotrafilcon B toric contact lenses with HYDRAGLYDE® in Period 1 or Period 2, as randomized |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead, CDMA Vision Care | Alcon, A Novartis Division | 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 | Nov 17, 2017 | Jan 4, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2017 | Jan 4, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lotrafilcon B toric contact lenses | Device | Silicone hydrogel soft contact lenses for astigmatism |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Lotrafilcon B toric contact lenses worn in both eyes for approximately 30 minutes in either Period 1 or Period 2, as randomized |
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| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | AO Toric | All subjects exposed to lotrafilcon B toric contact lenses in Period 1 or Period 2, as randomized | 0 | 36 | 0 | 36 | 0 | 36 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.