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Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fanfilcon A toric lens | Experimental | Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. |
|
| senofilcon A toric lens | Active Comparator | Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fanfilcon A toric lens | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) | Baseline |
| Lens Centration | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) | 2 weeks |
| Corneal Coverage | Lens covering the cornea (Yes, No) | Baseline |
| Corneal Coverage | Lens covering the cornea (Yes, No) | 2 weeks |
| Post Blink Movement | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) | Baseline |
| Post Blink Movement | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wearing Time | Average daily wearing time (hours/day) | 2 weeks |
| Comfortable Wearing Time | Comfortable daily wearing time (hours/day) | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Velázquez Guerrero, MSc., FIACLE | School of Optometry, National Autonomous University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic, National Autonomous University | Mexico City | Mexico |
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45 habitual lens wearers were enrolled. 1 participant was ineligible for the study due to an unacceptable lens fit. 44 participants were dispensed and completed all study visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fanfilcon A Toric | Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. Contact Lens: fanfilcon A toric |
| FG001 | Senofilcon A Toric | Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. Contact Lens: senofilcon A toric |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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A total of 45 subjects were enrolled. One participant was ineligible for the study due to an unacceptable lens fit at the first visit. A total of 44 subjects were dispensed and completed all study visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All subjects are randomized to 2-week cross-over study to compare fanfilcon A and senofilcon A. |
| 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, Categorical | Count of Participants |
| 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 | Lens Centration | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) | Posted | Count of Participants | Participants | Baseline |
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2 weeks during each crossover period
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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 | Fanfilcon A | Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. fanfilcon A toric lens: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc., FAAO | CooperVision Inc. | 9256213761 | javega@coopervision.com |
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| 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 | Apr 23, 2018 | Oct 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.
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Double masked (participant and investigator)
| senofilcon A toric lens | Device | contact lens |
|
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Lens Centration | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) | Posted | Count of Participants | Participants | 2 weeks |
|
|
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| Primary | Corneal Coverage | Lens covering the cornea (Yes, No) | Posted | Count of Participants | Participants | Baseline |
|
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| Primary | Corneal Coverage | Lens covering the cornea (Yes, No) | Posted | Count of Participants | Participants | 2 weeks |
|
|
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| Primary | Post Blink Movement | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Post Blink Movement | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
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| Secondary | Wearing Time | Average daily wearing time (hours/day) | Posted | Mean | Standard Deviation | hours/day | 2 weeks |
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| Secondary | Comfortable Wearing Time | Comfortable daily wearing time (hours/day) | Posted | Mean | Standard Deviation | hours/day | 2 weeks |
|
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| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Senofilcon A | Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. senofilcon A toric lens: contact lens | 0 | 44 | 0 | 44 | 0 | 44 |
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| Decentration unacceptable |
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