Skip to content

Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02410824
Enrollment
52
Registered
2015-04-08
Start date
2015-04-30
Completion date
2015-06-30
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism

Brief summary

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Detailed description

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.

Interventions

DEVICEstenfilcon A toric lens

toric contact lens

DEVICEetafilcon A toric lens

toric contact lens

Sponsors

CooperVision, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Is an adapted soft contact lens wearer; * Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye * Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes); * Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week; * Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye; * To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.

Exclusion criteria

* Is participating in any concurrent clinical or research study; * Has any known active\* ocular disease and/or infection; * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; * Is pregnant, lactating (by verbal confirmation at the screening visit); * Is aphakic; * Has undergone refractive error surgery

Design outcomes

Primary

MeasureTime frameDescription
Lens Fit AcceptanceBaseline and 1 WeekLens 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.
Conjunctival StainingBaseline and 1 weekOcular 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
Lens Durability1 WeekLens 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).
Corneal Staining, TypeBaseline and 1 weekOcular 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
ComfortBaseline and 1 WeekSubjective 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.
HandlingBaseline and 1 WeekSubjective 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.
VisionBaseline and 1 WeekSubjective 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.
High Visual AcuityBaseline and 1 WeekHigh 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.
Low Visual AcuityBaseline and 1 WeekLow 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.
Lens Surface - WettabilityBaseline and 1 WeekLens 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.
Lens Surface - DepositsBaseline and 1 WeekLens 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.
Corneal Staining, ExtentBaseline and 1 weekOcular 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

Secondary

MeasureTime frameDescription
Overall SatisfactionBaseline and 1 weekOverall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.
Dryness1 WeekSubjective 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.

Countries

Canada, United States

Participant flow

Pre-assignment details

7 subjects discontinued before lens randomization due to screen failure.

Participants by arm

ArmCount
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.
44
Total44

Withdrawals & dropouts

PeriodReasonFG000FG001
First Intervention (One Week)Headache01

Baseline characteristics

CharacteristicOverall Baseline Characteristics
Age, Continuous26 years
STANDARD_DEVIATION 9
Region of Enrollment
Canada
21 participants
Region of Enrollment
United States
23 participants
Sex: Female, Male
Female
34 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 440 / 44
serious
Total, serious adverse events
0 / 440 / 44

Outcome results

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.

Time frame: Baseline and 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensComfortBaseline88 units on a scaleStandard Deviation 13
Stenfilcon A Toric LensComfort1 week85 units on a scaleStandard Deviation 14
Etafilcon A Toric LensComfortBaseline78 units on a scaleStandard Deviation 18
Etafilcon A Toric LensComfort1 week77 units on a scaleStandard Deviation 21
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

Time frame: Baseline and 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensConjunctival StainingBaseline - Nasal0.36 units on a scaleStandard Deviation 0.6
Stenfilcon A Toric LensConjunctival Staining1 week - Nasal1.19 units on a scaleStandard Deviation 0.82
Stenfilcon A Toric LensConjunctival StainingBaseline - Temporal0.28 units on a scaleStandard Deviation 0.41
Stenfilcon A Toric LensConjunctival Staining1 week - Temporal1.06 units on a scaleStandard Deviation 0.7
Stenfilcon A Toric LensConjunctival StainingBaseline - Superior0.09 units on a scaleStandard Deviation 0.3
Stenfilcon A Toric LensConjunctival Staining1 week - Superior0.13 units on a scaleStandard Deviation 0.34
Stenfilcon A Toric LensConjunctival StainingBaseline - Inferior0.22 units on a scaleStandard Deviation 0.41
Stenfilcon A Toric LensConjunctival Staining1 week - Inferior0.68 units on a scaleStandard Deviation 0.79
Etafilcon A Toric LensConjunctival Staining1 week - Inferior0.78 units on a scaleStandard Deviation 0.96
Etafilcon A Toric LensConjunctival StainingBaseline - Nasal0.36 units on a scaleStandard Deviation 0.6
Etafilcon A Toric LensConjunctival StainingBaseline - Superior0.09 units on a scaleStandard Deviation 0.3
Etafilcon A Toric LensConjunctival Staining1 week - Nasal1.49 units on a scaleStandard Deviation 0.96
Etafilcon A Toric LensConjunctival StainingBaseline - Inferior0.22 units on a scaleStandard Deviation 0.41
Etafilcon A Toric LensConjunctival StainingBaseline - Temporal0.28 units on a scaleStandard Deviation 0.41
Etafilcon A Toric LensConjunctival Staining1 week - Superior0.09 units on a scaleStandard Deviation 0.27
Etafilcon A Toric LensConjunctival Staining1 week - Temporal0.91 units on a scaleStandard Deviation 0.76
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

Time frame: Baseline and 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensCorneal Staining, ExtentBaseline - Central0.07 units on a scaleStandard Deviation 0.3
Stenfilcon A Toric LensCorneal Staining, Extent1 week - Central0.07 units on a scaleStandard Deviation 0.26
Stenfilcon A Toric LensCorneal Staining, ExtentBaseline - Nasal0.13 units on a scaleStandard Deviation 0.3
Stenfilcon A Toric LensCorneal Staining, Extent1 week - Nasal0.06 units on a scaleStandard Deviation 0.25
Stenfilcon A Toric LensCorneal Staining, ExtentBaseline - Temporal0.09 units on a scaleStandard Deviation 0.28
Stenfilcon A Toric LensCorneal Staining, Extent1 week - Temporal0.02 units on a scaleStandard Deviation 0.12
Stenfilcon A Toric LensCorneal Staining, ExtentBaseline - Superior0.09 units on a scaleStandard Deviation 0.27
Stenfilcon A Toric LensCorneal Staining, Extent1 week - Superior0.22 units on a scaleStandard Deviation 0.46
Stenfilcon A Toric LensCorneal Staining, ExtentBaseline - Inferior0.47 units on a scaleStandard Deviation 0.59
Stenfilcon A Toric LensCorneal Staining, Extent1 week - Inferior0.28 units on a scaleStandard Deviation 0.55
Etafilcon A Toric LensCorneal Staining, Extent1 week - Superior0.20 units on a scaleStandard Deviation 0.42
Etafilcon A Toric LensCorneal Staining, ExtentBaseline - Central0.07 units on a scaleStandard Deviation 0.3
Etafilcon A Toric LensCorneal Staining, Extent1 week - Temporal0.13 units on a scaleStandard Deviation 0.38
Etafilcon A Toric LensCorneal Staining, Extent1 week - Central0.01 units on a scaleStandard Deviation 0.11
Etafilcon A Toric LensCorneal Staining, Extent1 week - Inferior0.41 units on a scaleStandard Deviation 0.61
Etafilcon A Toric LensCorneal Staining, ExtentBaseline - Nasal0.13 units on a scaleStandard Deviation 0.3
Etafilcon A Toric LensCorneal Staining, ExtentBaseline - Superior0.09 units on a scaleStandard Deviation 0.27
Etafilcon A Toric LensCorneal Staining, Extent1 week - Nasal0.14 units on a scaleStandard Deviation 0.36
Etafilcon A Toric LensCorneal Staining, ExtentBaseline - Inferior0.47 units on a scaleStandard Deviation 0.59
Etafilcon A Toric LensCorneal Staining, ExtentBaseline - Temporal0.09 units on a scaleStandard Deviation 0.28
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

Time frame: Baseline and 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensCorneal Staining, TypeBaseline - Central0.09 units on a scaleStandard Deviation 0.32
Stenfilcon A Toric LensCorneal Staining, Type1 week - Central0.07 units on a scaleStandard Deviation 0.27
Stenfilcon A Toric LensCorneal Staining, TypeBaseline - Nasal0.19 units on a scaleStandard Deviation 0.42
Stenfilcon A Toric LensCorneal Staining, Type1 week - Nasal0.13 units on a scaleStandard Deviation 0.54
Stenfilcon A Toric LensCorneal Staining, TypeBaseline - Temporal0.09 units on a scaleStandard Deviation 0.28
Stenfilcon A Toric LensCorneal Staining, Type1 week - Temporal0.01 units on a scaleStandard Deviation 0.2
Stenfilcon A Toric LensCorneal Staining, TypeBaseline - Superior0.12 units on a scaleStandard Deviation 0.34
Stenfilcon A Toric LensCorneal Staining, Type1 week - Superior0.36 units on a scaleStandard Deviation 0.62
Stenfilcon A Toric LensCorneal Staining, TypeBaseline - Inferior0.56 units on a scaleStandard Deviation 0.75
Stenfilcon A Toric LensCorneal Staining, Type1 week - Inferior0.30 units on a scaleStandard Deviation 0.58
Etafilcon A Toric LensCorneal Staining, Type1 week - Superior0.24 units on a scaleStandard Deviation 0.49
Etafilcon A Toric LensCorneal Staining, TypeBaseline - Central0.09 units on a scaleStandard Deviation 0.32
Etafilcon A Toric LensCorneal Staining, Type1 week - Temporal0.14 units on a scaleStandard Deviation 0.42
Etafilcon A Toric LensCorneal Staining, Type1 week - Central0.02 units on a scaleStandard Deviation 0.21
Etafilcon A Toric LensCorneal Staining, Type1 week - Inferior0.49 units on a scaleStandard Deviation 0.79
Etafilcon A Toric LensCorneal Staining, TypeBaseline - Nasal0.19 units on a scaleStandard Deviation 0.42
Etafilcon A Toric LensCorneal Staining, TypeBaseline - Superior0.12 units on a scaleStandard Deviation 0.34
Etafilcon A Toric LensCorneal Staining, Type1 week - Nasal0.22 units on a scaleStandard Deviation 0.62
Etafilcon A Toric LensCorneal Staining, TypeBaseline - Inferior0.56 units on a scaleStandard Deviation 0.75
Etafilcon A Toric LensCorneal Staining, TypeBaseline - Temporal0.09 units on a scaleStandard Deviation 0.28
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.

Time frame: Baseline and 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensHandlingBaseline87 units on a scaleStandard Deviation 12
Stenfilcon A Toric LensHandling1 week87 units on a scaleStandard Deviation 18
Etafilcon A Toric LensHandlingBaseline81 units on a scaleStandard Deviation 16
Etafilcon A Toric LensHandling1 week81 units on a scaleStandard Deviation 23
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.

Time frame: Baseline and 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensHigh Visual Acuity1 week-0.09 LogMARStandard Deviation 0.07
Stenfilcon A Toric LensHigh Visual AcuityBaseline-0.10 LogMARStandard Deviation 0.06
Etafilcon A Toric LensHigh Visual Acuity1 week-0.09 LogMARStandard Deviation 0.07
Etafilcon A Toric LensHigh Visual AcuityBaseline-0.08 LogMARStandard Deviation 0.06
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).

Time frame: 1 Week

ArmMeasureValue (NUMBER)
Stenfilcon A Toric LensLens Durability1 Lens tear or nick
Etafilcon A Toric LensLens Durability0 Lens tear or nick
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.

Time frame: Baseline and 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensLens Fit AcceptanceBaseline3.5 units on a scaleStandard Deviation 0.3
Stenfilcon A Toric LensLens Fit Acceptance1 week3.5 units on a scaleStandard Deviation 0.4
Etafilcon A Toric LensLens Fit AcceptanceBaseline3.4 units on a scaleStandard Deviation 0.3
Etafilcon A Toric LensLens Fit Acceptance1 week3.3 units on a scaleStandard Deviation 0.4
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.

Time frame: Baseline and 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensLens Surface - DepositsBaseline0.09 units on a scaleStandard Deviation 0.23
Stenfilcon A Toric LensLens Surface - Deposits1 week0.18 units on a scaleStandard Deviation 0.28
Etafilcon A Toric LensLens Surface - DepositsBaseline0.11 units on a scaleStandard Deviation 0.24
Etafilcon A Toric LensLens Surface - Deposits1 week0.25 units on a scaleStandard Deviation 0.37
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.

Time frame: Baseline and 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensLens Surface - WettabilityBaseline3.2 units on a scaleStandard Deviation 0.8
Stenfilcon A Toric LensLens Surface - Wettability1 week3.2 units on a scaleStandard Deviation 0.7
Etafilcon A Toric LensLens Surface - WettabilityBaseline3.4 units on a scaleStandard Deviation 0.5
Etafilcon A Toric LensLens Surface - Wettability1 week3.3 units on a scaleStandard Deviation 0.7
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.

Time frame: Baseline and 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensLow Visual AcuityBaseline-0.08 LogMARStandard Deviation 0.06
Stenfilcon A Toric LensLow Visual Acuity1 week-0.07 LogMARStandard Deviation 0.07
Etafilcon A Toric LensLow Visual AcuityBaseline-0.07 LogMARStandard Deviation 0.06
Etafilcon A Toric LensLow Visual Acuity1 week-0.07 LogMARStandard Deviation 0.07
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.

Time frame: Baseline and 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensVisionBaseline83 units on a scaleStandard Deviation 16
Stenfilcon A Toric LensVision1 week86 units on a scaleStandard Deviation 17
Etafilcon A Toric LensVision1 week83 units on a scaleStandard Deviation 17
Etafilcon A Toric LensVisionBaseline78 units on a scaleStandard Deviation 21
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.

Time frame: 1 Week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensDrynessDuring the Day82 units on a scaleStandard Deviation 18
Stenfilcon A Toric LensDrynessEnd of Day76 units on a scaleStandard Deviation 21
Etafilcon A Toric LensDrynessDuring the Day74 units on a scaleStandard Deviation 23
Etafilcon A Toric LensDrynessEnd of Day67 units on a scaleStandard Deviation 24
Secondary

Overall Satisfaction

Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.

Time frame: Baseline and 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Stenfilcon A Toric LensOverall SatisfactionBaseline87 units on a scaleStandard Deviation 13
Stenfilcon A Toric LensOverall Satisfaction1 week83 units on a scaleStandard Deviation 17
Etafilcon A Toric LensOverall SatisfactionBaseline80 units on a scaleStandard Deviation 16
Etafilcon A Toric LensOverall Satisfaction1 week77 units on a scaleStandard Deviation 23

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026