Myopia
Conditions
Brief summary
The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.
Interventions
DEVICEcomfilcon A, BC 8.60
comfilcon A, BC 8.60 soft contact lens
DEVICEgalyfilcon A, BC 8.30
galyfilcon A, BC 8.30 soft contact lens
DEVICElotrafilcon B, BC 8.60
lotrafilcon B, BC 8.60 soft contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Be no less than 18 and no more than 39 years of age. * Sign Written Informed Consent and investigator to record this on Case Report Form. * Be willing and able to adhere to the instructions set out in the protocol. * Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month. * No extended wear in the last 3 months. * Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters. * Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes. * Achieve visual acuity of 6/9 (20/30) or better in each eye. * Require a visual correction in both eyes (no monovision allowed). * Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.
Exclusion criteria
* Requires concurrent ocular medication. * Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. * Clinically significant corneal staining * Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters). * Has had refractive surgery. * Has had eye injury/surgery within 8 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. * Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks. * Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * Diabetic. * Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease \[e.g., Human immunodeficiency virus (HIV)\]. * History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration). * Pregnancy, lactating or planning a pregnancy at the time of enrollment. * Participation in any concurrent clinical trial or in last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Subjective Comfort | after 2 weeks of contact lens wear | Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. |
| Corneal Staining | after 2 weeks of contact lens wear | Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Subjective Lens Handling | after 2 weeks of contact lens wear | Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated. |
Countries
United States
Participant flow
Recruitment details
There were thirty-five sites recruited in the US. There were 540 subjects recruited with 520 enrolled and randomized. The study was a 2-week, randomized, single-masked (subjects), parallel arm, bilateral dispensing study. The subject group was expected to be representative of a cross-section of the population within the US contact lens market.
Pre-assignment details
There were 20 subjects who did not meet the inclusion or did meet the exclusion criteria. There were 10 screen failures and 10 who wore spectacles to baseline visit invoking the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Galyfilcon A Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study. | 163 |
| Lotrafilcon B Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study. | 170 |
| Comfilcon A Subjects that were randomized to wear comfilcon A lens throughout the course of the study. | 168 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1 (Baseline to 1-week Visit) | Poor comfort | 0 | 0 | 1 |
| Period 1 (Baseline to 1-week Visit) | Poor Vision | 0 | 1 | 0 |
| Period 1 (Baseline to 1-week Visit) | Protocol Violation | 4 | 5 | 2 |
| Period 2 (1-week to 2-week Visit) | Adverse Event | 2 | 0 | 0 |
| Period 2 (1-week to 2-week Visit) | Lost to Follow-up | 0 | 1 | 0 |
| Period 2 (1-week to 2-week Visit) | Poor Comfort | 0 | 0 | 1 |
| Period 2 (1-week to 2-week Visit) | Protocol Violation | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Galyfilcon A | Lotrafilcon B | Comfilcon A | Total |
|---|---|---|---|---|
| Age, Continuous | 28.8 years STANDARD_DEVIATION 5.9 | 28.3 years STANDARD_DEVIATION 5.6 | 27.4 years STANDARD_DEVIATION 5.7 | 28.2 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment United Kingdom | 163 Participants | 170 Participants | 168 Participants | 501 Participants |
| Sex: Female, Male Female | 108 Participants | 118 Participants | 115 Participants | 341 Participants |
| Sex: Female, Male Male | 55 Participants | 52 Participants | 53 Participants | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 170 | 0 / 177 | 0 / 173 |
| serious Total, serious adverse events | 0 / 170 | 0 / 177 | 0 / 173 |
Outcome results
Primary
Corneal Staining
Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.
Time frame: after 2 weeks of contact lens wear
Population: Analysis is on those subjects who completed the study (n=501).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Galyfilcon A | Corneal Staining | No corneal staining | 78.5 percentage of eyes |
| Galyfilcon A | Corneal Staining | With corneal staining | 21.5 percentage of eyes |
| Lotrafilcon B | Corneal Staining | No corneal staining | 67.1 percentage of eyes |
| Lotrafilcon B | Corneal Staining | With corneal staining | 32.9 percentage of eyes |
| Comfilcon A | Corneal Staining | No corneal staining | 66.1 percentage of eyes |
| Comfilcon A | Corneal Staining | With corneal staining | 33.9 percentage of eyes |
Comparison: The comparison is between galyfilcon A (AAHP) and lotrafilcon B (AOA) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/AOA). Ha: OR \> 1 for (AAHP/AOA).97.4% CI: [1.14, 2.44]Regression, Logistic
Comparison: The comparison is between galyfilcon A (AAHP) and comfilcon A (BIO) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/BIO). Ha: OR \> 1 for (AAHP/BIO).97.4% CI: [1.14, 2.44]Regression, Logistic
Primary
Overall Subjective Comfort
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: after 2 weeks of contact lens wear
Population: Analysis is on those subjects who completed the study (n=501).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A | Overall Subjective Comfort | 51.7 CLUE score | Standard Error 2.1 |
| Lotrafilcon B | Overall Subjective Comfort | 51.3 CLUE score | Standard Error 2 |
| Comfilcon A | Overall Subjective Comfort | 51.3 CLUE score | Standard Error 2 |
Comparison: This comparison is between galyfilcon and lotrafilcon B. Ho: galyfilcon A -lotrafilcon B \<= -5. Ha: galyfilcon A - lotrafilcon B \> -5.97.4% CI: [-5.91, 6.7]Mixed Models Analysis
Comparison: This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A \<= -5. Ha: galyfilcon A- comfilcon A\> -5.97.4% CI: [-5.96, 6.79]Mixed Models Analysis
Secondary
Overall Subjective Lens Handling
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.
Time frame: after 2 weeks of contact lens wear
Population: Analysis is on those subjects who completed the study (n=331) and where assigned to these two arms. Analysis is restricted to these two arms for this outcome as specified per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A | Overall Subjective Lens Handling | 64.3 CLUE score | Standard Error 1.6 |
| Lotrafilcon B | Overall Subjective Lens Handling | 59.8 CLUE score | Standard Error 1.6 |