Myopia, Hyperopia, Refractive Error
Conditions
Keywords
Soft contact lenses, Daily disposable contact lenses, Tear Film Break Up Time, Contact lens wettability
Brief summary
The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.
Detailed description
Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent. * Adapted soft contact lens wearer. * Willing to wear contact lenses up to 12 hours and attend all study visits. * Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1. * Contact lens prescription within the power range specified in the protocol. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. * Any use of systemic or ocular medications that would contraindicate contact lens wear. * Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear. * Monocular (only 1 eye with functional vision) or fit with only 1 lens. * History of herpetic keratitis, ocular surgery, or irregular cornea. * Known pregnancy. * Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses. * Participation in any clinical study within 30 days of Visit 1. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours | Hour 8 | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Wettability Score | Hour 8 | The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean. |
Participant flow
Recruitment details
Participants were recruited from 1 study center located in Germany.
Pre-assignment details
Of the 30 enrolled, 2 participants discontinued before product was dispensed. This reporting group includes all participants exposed to the study product (28). In this 3-treatment, 6-sequence crossover study, each participant received all 3 products in randomized order and used 1 product at a time for a duration of 12 hours.
Participants by arm
| Arm | Count |
|---|---|
| Overall Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 24.96 years STANDARD_DEVIATION 3.54 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 6 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 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.
Time frame: Hour 8
Population: This analysis population includes all participants exposed to the study product with reportable values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DAILIES AquaComfort Plus | Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours | 5.28 seconds | Standard Deviation 5.71 |
| 1-DAY ACUVUE MOIST | Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours | 3.46 seconds | Standard Deviation 4.52 |
| Proclear 1 Day | Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours | 4.93 seconds | Standard Deviation 6.34 |
Secondary
Total Wettability Score
The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.
Time frame: Hour 8
Population: This analysis population includes all participants exposed to the study product with reportable values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES AquaComfort Plus | Total Wettability Score | 20 seconds post blink | 1.69 units on a scale | Standard Deviation 1.21 |
| DAILIES AquaComfort Plus | Total Wettability Score | 10 seconds post blink | 1.25 units on a scale | Standard Deviation 1.15 |
| DAILIES AquaComfort Plus | Total Wettability Score | 25 seconds post blink | 1.79 units on a scale | Standard Deviation 1.18 |
| DAILIES AquaComfort Plus | Total Wettability Score | 15 seconds post blink | 1.58 units on a scale | Standard Deviation 1.2 |
| DAILIES AquaComfort Plus | Total Wettability Score | 5 seconds post blink | 0.74 units on a scale | Standard Deviation 0.93 |
| 1-DAY ACUVUE MOIST | Total Wettability Score | 10 seconds post blink | 1.20 units on a scale | Standard Deviation 1.14 |
| 1-DAY ACUVUE MOIST | Total Wettability Score | 20 seconds post blink | 1.78 units on a scale | Standard Deviation 1.22 |
| 1-DAY ACUVUE MOIST | Total Wettability Score | 5 seconds post blink | 0.83 units on a scale | Standard Deviation 0.87 |
| 1-DAY ACUVUE MOIST | Total Wettability Score | 25 seconds post blink | 1.94 units on a scale | Standard Deviation 1.19 |
| 1-DAY ACUVUE MOIST | Total Wettability Score | 15 seconds post blink | 1.54 units on a scale | Standard Deviation 1.21 |
| Proclear 1 Day | Total Wettability Score | 25 seconds post blink | 2.03 units on a scale | Standard Deviation 1.17 |
| Proclear 1 Day | Total Wettability Score | 10 seconds post blink | 1.42 units on a scale | Standard Deviation 1.2 |
| Proclear 1 Day | Total Wettability Score | 15 seconds post blink | 1.66 units on a scale | Standard Deviation 1.19 |
| Proclear 1 Day | Total Wettability Score | 20 seconds post blink | 1.89 units on a scale | Standard Deviation 1.18 |
| Proclear 1 Day | Total Wettability Score | 5 seconds post blink | 0.84 units on a scale | Standard Deviation 0.96 |