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 study objective was to gather short-term clinical performance data for two soft toric contact lenses.
This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens 1 | Experimental | All participants wore Lens 1 for 15 minutes (Period 1) |
|
| Lens 2 | Experimental | All participants wore Lens 2 for 15 minutes (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens 1 (omafilcon B) | Device | Toric daily wear contact lens for 15 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Score | The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort | Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent. | 15 minutes |
| Subjective Vision |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, PhD, MCOptom | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PL | United Kingdom |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lens 1 (Omafilcon B) | All participants wore Lens 1 for 15 minutes (Period 1) |
| FG001 | Lens 2 (Fanfilcon A) | All participants wore Lens 2 for 15 minutes (Period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Lens 1, 15 Minutes |
| |||||||||||||
| Period 2: Lens 2, 15 Minutes |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes all study participants. |
| 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 | Subjective Overall Score | The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent. | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
|
Duration of the study, approximately 1.5 hours.
Not provided
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 | Lens 1 | Participants that received Lens 1 | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega OD, MSc, FAAO | CooperVision Inc. | +19256213761 | jvega2@coopervision.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2022 | Oct 11, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
All participants received Lens 1 and then Lens 2 in fixed-sequence order.
Not provided
Not provided
Not provided
| Lens 2 (fanfilcon A) |
| Device |
Toric daily wear contact lens for 15 minutes |
|
Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent.
| 15 minutes |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Subjective Comfort | Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent. | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
|
|
| Secondary | Subjective Vision | Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent. | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
|
|
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Lens 2 | Participants that received Lens 2 | 0 | 40 | 0 | 40 | 0 | 40 |
Not provided
Not provided