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
Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.
CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A toric lens | Experimental | Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. |
|
| etafilcon A toric lens | Active Comparator | Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A toric lens | Device | toric contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt. | Baseline and 1 Week |
| Handling | Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle. | Baseline and 1 Week |
| Vision | Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent. | Baseline and 1 Week |
| High Visual Acuity | High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR. | Baseline and 1 Week |
| Low Visual Acuity | Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR. | Baseline and 1 Week |
| Lens Surface - Wettability | Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability. | Baseline and 1 Week |
| Lens Surface - Deposits |
| Measure | Description | Time Frame |
|---|---|---|
| Dryness | Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time. | 1 Week |
| Overall Satisfaction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Meng C Lin, OD PhD | UC Berkeley Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, University of California, Berkeley | Berkeley | California | 94704 | United States | ||
7 subjects discontinued before lens randomization due to screen failure.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens | Participants were randomized to wear stenfilcon A toric lens for one week, then cross over to the etafilcon A toric lens. stenfilcon A: toric contact lens etafilcon A: toric contact lens |
| FG001 | Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens | Participants were randomized to wear etafilcon A toric lens for one week, then cross over to the stenfilcon A toric lens. etafilcon A: toric contact lens stenfilcon A: toric contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (One Week) |
|
| ||||||||||||||||||
| Second Intervention (One Week) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline Characteristics | Participants were randomized to wear stenfilcon A toric lens or etafilcon A toric lens bilaterally for one week, then cross over to the alternative pair. |
| 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 | Comfort | Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
Not provided
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 | Stenfilcon A Toric Lens | Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager Clinical Research | CooperVision Inc. | 925-730-6754 | pchamberlain@coopervision.com |
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| etafilcon A toric lens |
| Device |
toric contact lens |
|
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits. |
| Baseline and 1 Week |
| Corneal Staining, Type | Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior | Baseline and 1 week |
| Corneal Staining, Extent | Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior | Baseline and 1 week |
| Conjunctival Staining | Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent N - Nasal, T - Temporal, S - Superior, I - Inferior | Baseline and 1 week |
| Lens Durability | Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study). | 1 Week |
| Lens Fit Acceptance | Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum. | Baseline and 1 Week |
Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.
| Baseline and 1 week |
| Center for Contact Lens Research, University of Waterloo |
| Waterloo |
| Ontario |
| N2L 3G1 |
| Canada |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Handling | Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Primary | Vision | Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Primary | High Visual Acuity | High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR. | Posted | Mean | Standard Deviation | LogMAR | Baseline and 1 Week |
|
|
|
| Primary | Low Visual Acuity | Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR. | Posted | Mean | Standard Deviation | LogMAR | Baseline and 1 Week |
|
|
|
| Primary | Lens Surface - Wettability | Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Primary | Lens Surface - Deposits | Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Primary | Corneal Staining, Type | Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
|
| Primary | Corneal Staining, Extent | Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
|
| Primary | Conjunctival Staining | Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent N - Nasal, T - Temporal, S - Superior, I - Inferior | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
|
| Primary | Lens Durability | Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study). | Posted | Number | Lens tear or nick | 1 Week | Lenses | Lenses |
|
|
|
| Primary | Lens Fit Acceptance | Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Secondary | Dryness | Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time. | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
|
| Secondary | Overall Satisfaction | Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Etafilcon A Toric Lens | Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens | 0 | 44 | 0 | 44 |
Not provided
| Baseline - Nasal |
|
| 1 week - Nasal |
|
| Baseline - Temporal |
|
| 1 week - Temporal |
|
| Baseline - Superior |
|
| 1 week - Superior |
|
| Baseline - Inferior |
|
| 1 week - Inferior |
|
| Baseline - Nasal |
|
| 1 week - Nasal |
|
| Baseline - Temporal |
|
| 1 week - Temporal |
|
| Baseline - Superior |
|
| 1 week - Superior |
|
| Baseline - Inferior |
|
| 1 week - Inferior |
|
| Baseline - Temporal |
|
| 1 week - Temporal |
|
| Baseline - Superior |
|
| 1 week - Superior |
|
| Baseline - Inferior |
|
| 1 week - Inferior |
|