Myopia
Conditions
Brief summary
The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.
Interventions
DEVICEnarafilcon B
test product
DEVICEPolymacon
marketed product
DEVICELotrafilcon A
marketed product
OTHERSpectacles
None - subject used own spectacles
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Be of legal age (i.e. ≥ 18 years). * Be mentally competent, willing and able to sign a written informed consent form. * Have contact lens distance sphere requirement in the range -1.00D to -6.00D. * Have spectacle astigmatism \<1.25D in each eye. * Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription. * Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.
Exclusion criteria
* Required concurrent ocular medication. * Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear. * Eye injury or surgery within eight weeks immediately prior to enrollment for this study. * Abnormal lacrimal secretions. * Pre-existing ocular irritation that would preclude contact lens fitting. * Keratoconus or other corneal irregularity. * Pregnancy, lactating or planning a pregnancy at the time of enrollment. * Participation in any concurrent clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Thickness | After 8 hours of contact lens wear | Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent. |
| Endothelial Blebs | baseline, after 20 minutes of treatment conditions | Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline). |
| Limbal Redness | Baseline, After 8 hours of treatment conditions | Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | after 8 hours | Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best). |
Countries
Australia
Participant flow
Recruitment details
There were 22 subjects enrolled to the study, all completed the four experimental sessions.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Subjects who were enrolled and randomized to a trial arm. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 30.8 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Australia | 22 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Corneal Thickness
Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.
Time frame: After 8 hours of contact lens wear
Population: Subjects are those enrolled and randomized to a trial arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Spectacles No Lenses | Corneal Thickness | -0.35 Percent Change | Standard Error 0.15 |
| Narafilcon B | Corneal Thickness | -0.99 Percent Change | Standard Error 0.18 |
| Polymacon | Corneal Thickness | 0.75 Percent Change | Standard Error 0.21 |
| Lotrafilcon A | Corneal Thickness | -1.02 Percent Change | Standard Error 0.23 |
Comparison: Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.p-value: 0.0035Mixed Models Analysis
Comparison: Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.p-value: 0Mixed Models Analysis
Comparison: Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.p-value: 0.8957Mixed Models Analysis
Primary
Endothelial Blebs
Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).
Time frame: baseline, after 20 minutes of treatment conditions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spectacles No Lenses | Endothelial Blebs | -0.13 percentage of bleb area | Standard Error 0.31 |
| Narafilcon B | Endothelial Blebs | 0.49 percentage of bleb area | Standard Error 0.23 |
| Polymacon | Endothelial Blebs | 0.41 percentage of bleb area | Standard Error 0.4 |
| Lotrafilcon A | Endothelial Blebs | 0.38 percentage of bleb area | Standard Error 0.41 |
Comparison: Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.p-value: 0.0692Mixed Models Analysis
Comparison: Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.p-value: 0.7301Mixed Models Analysis
Comparison: Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.p-value: 0.8055Mixed Models Analysis
Primary
Limbal Redness
Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.
Time frame: Baseline, After 8 hours of treatment conditions
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Spectacles No Lenses | Limbal Redness | -0.03 units on a scale | Standard Error 0.06 |
| Narafilcon B | Limbal Redness | -0.04 units on a scale | Standard Error 0.5 |
| Polymacon | Limbal Redness | 0.64 units on a scale | Standard Error 0.1 |
| Lotrafilcon A | Limbal Redness | 0.13 units on a scale | Standard Error 0.08 |
Comparison: Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.p-value: 0.9127Mixed Models Analysis
Comparison: Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.p-value: 0Mixed Models Analysis
Comparison: Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.p-value: 0.1256Mixed Models Analysis
Secondary
Overall Comfort
Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).
Time frame: after 8 hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Spectacles No Lenses | Overall Comfort | 96.0 units on a scale | Standard Error 1.3 |
| Narafilcon B | Overall Comfort | 96.1 units on a scale | Standard Error 1 |
| Polymacon | Overall Comfort | 78.3 units on a scale | Standard Error 5.1 |
| Lotrafilcon A | Overall Comfort | 80.7 units on a scale | Standard Error 4.4 |
Comparison: Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.p-value: 0.9892Mixed Models Analysis
Comparison: Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.p-value: 0.0007Mixed Models Analysis
Comparison: Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.p-value: 0.003Mixed Models Analysis