Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelfilcon A invest'l / nelfilconA comm'l | Other | Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week. |
|
| Nelfilcon A comm'l / nelfilconA invest'l | Other | Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A investigational contact lens | Device | Investigational, soft contact lens for astigmatism worn on a daily disposable basis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Vision (Crisp and Clear) | Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week of wear |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This reporting group includes all enrolled and dispensed participants. One participant was enrolled but not dispensed due to unacceptable fit. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A Invest'l / nelfilconA Comm'l | Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week. |
| FG001 | Nelfilcon A Comm'l / nelfilconA Invest'l | Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, One Week of Wear |
| |||||||||||||
| Period 2, One Week of Wear |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This reporting group includes all enrolled and dispensed subjects. |
| 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 | Quality of Vision (Crisp and Clear) | Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | units on a scale | 1 week of wear | eyes | Participants |
|
Adverse event data were collected for the duration of the trial: 45 days.
This reporting group includes all enrolled and exposed participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nelfilcon A Investigational | Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management | CIBA VISION | 1-678-415-3343 | joseph.rappon@cibavision.com |
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nelfilcon A commercial contact lens | Device | Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis. |
|
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week. |
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | Nelfilcon A Commercial | Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week. | 0 | 93 | 0 | 93 |
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.