Myopia
Conditions
Brief summary
This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.
Interventions
DEVICEetafilcon A
contact lens worn daily for one week (first or second week depending on arm)
DEVICEnelfilcon A
Contact lens worn daily for one week (first or second week depending on arm)
Sponsors
University of Manchester
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
1. They are of legal age (18 years) and capacity to volunteer. 2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. 5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS. 6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC). 7. They have successfully worn contact lenses within six months of starting the study. -
Exclusion criteria
1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops or ointment. 4. They are aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. 7. They are pregnant or lactating. 8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. 9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV). 10. They have diabetes. 11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 2-week | Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (\< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination. |
| Subjective Lens Comfort | 2-week | Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported Overall Product Performance | 2-week | Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used. |
| Optimum Lens Fit | Baseline, 1-week, 2-week | Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria \[between -1 and +1 on a -2 to +2 grading scale. |
Countries
United Kingdom
Participant flow
Recruitment details
Sixty subjects were enrolled onto the study to wear contact lenses for two weeks on a daily wear basis.
Pre-assignment details
Sixty subjects enrolled and sixty subjects completed.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects crossed over to use each treatment for one week | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United Kingdom | 60 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Subjective Lens Comfort
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Time frame: 2-week
Population: Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Subjective Lens Comfort | 86.0 units on a scale | Standard Deviation 13.9 |
| Etafilcon A | Subjective Lens Comfort | 88.2 units on a scale | Standard Deviation 12.4 |
Primary
Visual Acuity
Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (\< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.
Time frame: 2-week
Population: Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nelfilcon A | Visual Acuity | High Contrast | -0.10 logMAR scale | Standard Deviation 0.07 |
| Nelfilcon A | Visual Acuity | Low Contrast | 0.17 logMAR scale | Standard Deviation 0.09 |
| Etafilcon A | Visual Acuity | High Contrast | -0.10 logMAR scale | Standard Deviation 0.07 |
| Etafilcon A | Visual Acuity | Low Contrast | 0.18 logMAR scale | Standard Deviation 0.09 |
Secondary
Optimum Lens Fit
Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria \[between -1 and +1 on a -2 to +2 grading scale.
Time frame: Baseline, 1-week, 2-week
Population: Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nelfilcon A | Optimum Lens Fit | At Dispensing | 22 participants |
| Nelfilcon A | Optimum Lens Fit | At Follow-up | 18 participants |
| Etafilcon A | Optimum Lens Fit | At Dispensing | 18 participants |
| Etafilcon A | Optimum Lens Fit | At Follow-up | 18 participants |
Secondary
Subject-reported Overall Product Performance
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Time frame: 2-week
Population: Analyzed subjects were those who were enrolled and randomized to a study arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Subject-reported Overall Product Performance | 86.5 units on a scale | Standard Error 11.3 |
| Etafilcon A | Subject-reported Overall Product Performance | 87.7 units on a scale | Standard Error 12.3 |