Refractive Error, Myopia
Conditions
Brief summary
This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.
Interventions
DEVICEHabitual Silicone Hydrogel Contact Lens
contact lens
DEVICEnarafilcon A
contact lens
Sponsors
University of Manchester
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They are of legal age (17 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 |
|---|---|---|
| Limbal Hyperemia | At 2 weeks and 4 weeks | Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames. |
| Lens Comfort | At 3,7,10,13,17,21,24, and 27 days | Rating of lens comfort by rating agreement to the following statement: The lenses I am wearing are comfortable. Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames. |
| Upper Lid Margin Staining | At 2 weeks and 4 weeks. | Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tarsal Roughness | At 2 weeks and 4 weeks | Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames. |
| Tarsal Hyperemia | At 2 weeks and 4 weeks. | Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe. |
| Corneal Staining | At 2 weeks and 4 weeks. | A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Habitual Silicone Hydrogel Habitual contact lens wear. | 40 |
| Narafilcon A Silicone hydrogel daily disposable contact lens | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Habitual Silicone Hydrogel | Narafilcon A | Total |
|---|---|---|---|
| Age, Continuous | 28.3 years STANDARD_DEVIATION 9.9 | 25.8 years STANDARD_DEVIATION 8.7 | 27.2 years STANDARD_DEVIATION 9.6 |
| Gender Female | 32 participants | 33 participants | 65 participants |
| Gender Male | 8 participants | 6 participants | 14 participants |
| Region of Enrollment Canada | 40 participants | 39 participants | 79 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Lens Comfort
Rating of lens comfort by rating agreement to the following statement: The lenses I am wearing are comfortable. Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Time frame: At 3,7,10,13,17,21,24, and 27 days
Population: The analysis includes all subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Habitual Silicone Hydrogel | Lens Comfort | 1.1078 units on a scale | Standard Error 0.4993 |
| Narafilcon A | Lens Comfort | 1.0274 units on a scale | Standard Error 0.5737 |
Comparison: The alternative hypothesis is that narafilcon A provides better comfort than the habitual lens by having a lower rating on the scale.99% CI: [-0.0804, 1.8821]Mixed Models Analysis
Primary
Limbal Hyperemia
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Time frame: At 2 weeks and 4 weeks
Population: The analysis includes all subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Habitual Silicone Hydrogel | Limbal Hyperemia | 34.0967 units on a scale | Standard Error 1.4982 |
| Narafilcon A | Limbal Hyperemia | 31.0920 units on a scale | Standard Error 1.7271 |
Comparison: The alternative hypothesis is that narafilcon A will provide a lower level of limbal hyperemia than the habitual lens.98.75% CI: [-3.0047, 2.7153]Mixed Models Analysis
Primary
Upper Lid Margin Staining
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.
Time frame: At 2 weeks and 4 weeks.
Population: The analysis includes all subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Habitual Silicone Hydrogel | Upper Lid Margin Staining | 0.9358 units on a scale. | Standard Error 1.1146 |
| Narafilcon A | Upper Lid Margin Staining | 1.1586 units on a scale. | Standard Error 1.2857 |
Comparison: The alternative hypothesis is that narafilcon A provides a lowe level of upper lid margin staining than the habitual lens.99% CI: [0.2228, 4.6564]Mixed Models Analysis
Secondary
Corneal Staining
A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.
Time frame: At 2 weeks and 4 weeks.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Habitual Silicone Hydrogel | Corneal Staining | 6.6173 units on a scale | Standard Error 1.1106 |
| Narafilcon A | Corneal Staining | 6.3763 units on a scale | Standard Error 1.282 |
Comparison: The alternative hypothesis is that narafilcon A provides lower levels of corneal staining than the habitual lens.98.75% CI: [-0.241, 4.0043]Mixed Models Analysis
Secondary
Tarsal Hyperemia
Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
Time frame: At 2 weeks and 4 weeks.
Population: The analysis includes all subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Habitual Silicone Hydrogel | Tarsal Hyperemia | 38.4103 units on a scale | Standard Error 1.5238 |
| Narafilcon A | Tarsal Hyperemia | 37.5478 units on a scale | Standard Error 1.7646 |
Comparison: The alternative hypothesis is that narafilcon A provides a lower level of tarsal hyperemia than the habitual lens.98.75% CI: [-0.8625, 5.0524]Mixed Models Analysis
Secondary
Tarsal Roughness
Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.
Time frame: At 2 weeks and 4 weeks
Population: The analysis includes all subjects that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Habitual Silicone Hydrogel | Tarsal Roughness | 30.1028 units on a scale | Standard Error 0.7784 |
| Narafilcon A | Tarsal Roughness | 31.3624 units on a scale | Standard Error 0.8994 |
98.75% CI: [1.2596, 4.2599]Mixed Models Analysis