Astigmatism
Conditions
Brief summary
This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.
Interventions
DEVICEsenofilcon A toric
silicone hydrogel contact lens for patients with astigmatism
DEVICEgalyfilcon A toric
silicone hydrogel contact lens for patients with astigmatism
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to wear study lenses in parameters available. * At least 18 * understand and sign informed consent * willing to follow the protocol * achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses * hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180 * oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months
Exclusion criteria
* Any ocular or systemic disorder which may contraindicate Contact Lens (CL) wear * any topical ocular medication * aphakic * corneal refractive surgery, * corneal distortion from hard CL wear or keratoconus * pregnant or lactating * grade 2 or worse slit lamp signs * infectious disease * previous clinical study within 2 weeks * don't agree to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | after 6 hours of wear | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted) | after 6 hours of wear | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | after 6 hours of wear | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | after 6 hours of wear | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted) | after 6 hours of wear | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | after 6 hours of wear | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | after 6 hours of wear | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted) | after 6 hours of wear | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | after 6 hours of wear | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | after 6 hours of wear | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted) | after 6 hours of wear | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | after 6 hours of wear | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | after 6 hours of wear | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted) | after 6 hours of wear | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
| Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | after 6 hours of wear | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Completed Subjects All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | All Completed Subjects |
|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment United Kingdom | 38 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 19 | 2 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 11 subjects that were high myopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 1.10 Units on a scale | Standard Error 0.05 |
| Galyfilcon A | Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 1.23 Units on a scale | Standard Error 0.05 |
Comparison: Alternative hypothesis is that senoflicon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.97.5% CI: [-0.29, 0.04]Mixed Models Analysis
Primary
Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 14 subjects that were hyperopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted) | 1.16 Units on a scale | Standard Error 0.07 |
| Galyfilcon A | Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted) | 1.18 Units on a scale | Standard Error 0.05 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.97.5% CI: [-0.1, 0.06]Mixed Models Analysis
Primary
Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 1.08 Units on a scale | Standard Error 0.07 |
| Galyfilcon A | Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 1.14 Units on a scale | Standard Error 0.08 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.97.5% CI: [-0.23, 0.1]Mixed Models Analysis
Primary
Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 11 subjects that were high myopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 1.68 Units on a scale | Standard Error 0.09 |
| Galyfilcon A | Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 1.69 Units on a scale | Standard Error 0.14 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.97.5% CI: [-0.27, 0.26]Mixed Models Analysis
Primary
Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 14 subjects that were hyperopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted) | 0.96 Units on a scale | Standard Error 0.1 |
| Galyfilcon A | Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted) | 1.17 Units on a scale | Standard Error 0.08 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.97.5% CI: [-0.34, -0.08]Mixed Models Analysis
Primary
Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 1.12 Units on a scale | Standard Error 0.09 |
| Galyfilcon A | Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 1.42 Units on a scale | Standard Error 0.08 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.97.5% CI: [-0.54, -0.15]Mixed Models Analysis
Primary
Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 11 subjects that were high myopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 0.40 Units on a scale | Standard Error 0.07 |
| Galyfilcon A | Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 0.22 Units on a scale | Standard Error 0.05 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.97.5% CI: [0.04, 0.32]Mixed Models Analysis
Primary
Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 14 subjects that were hyperopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted) | 0.19 Units on a scale | Standard Error 0.07 |
| Galyfilcon A | Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted) | 0.28 Units on a scale | Standard Error 0.09 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.97.5% CI: [-0.26, 0.08]Mixed Models Analysis
Primary
Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 0.35 Units on a scale | Standard Error 0.08 |
| Galyfilcon A | Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 0.18 Units on a scale | Standard Error 0.08 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.97.5% CI: [0.02, 0.33]Mixed Models Analysis
Primary
Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 11 subjects that were high myopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 0.97 Units on a scale | Standard Error 0.05 |
| Galyfilcon A | Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 1.07 Units on a scale | Standard Error 0.07 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.97.5% CI: [-0.25, 0.04]Mixed Models Analysis
Primary
Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 14 subjects that were hyperopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted) | 0.95 Units on a scale | Standard Error 0.06 |
| Galyfilcon A | Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted) | 1.00 Units on a scale | Standard Error 0.06 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.97.5% CI: [-0.16, 0.07]Mixed Models Analysis
Primary
Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 1.01 Units on a scale | Standard Error 0.08 |
| Galyfilcon A | Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 1.06 Units on a scale | Standard Error 0.07 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.97.5% CI: [-0.25, 0.14]Mixed Models Analysis
Primary
Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 11 subjects that were high myopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 1.09 Units on a scale | Standard Error 0.07 |
| Galyfilcon A | Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | 1.08 Units on a scale | Standard Error 0.07 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.97.5% CI: [-0.12, 0.14]Mixed Models Analysis
Primary
Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 14 subjects that were hyperopes within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted) | 1.12 Units on a scale | Standard Error 0.06 |
| Galyfilcon A | Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted) | 1.21 Units on a scale | Standard Error 0.09 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.97.5% CI: [-0.23, 0.05]Mixed Models Analysis
Primary
Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time frame: after 6 hours of wear
Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 1.01 Units on a scale | Standard Error 0.05 |
| Galyfilcon A | Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | 1.10 Units on a scale | Standard Error 0.04 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.97.5% CI: [-0.2, 0.02]Mixed Models Analysis