Myopia
Conditions
Keywords
Myopia, Contact Lenses
Brief summary
The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.
Interventions
Silicone hydrogel contact lens for single use, daily disposable wear.
Silicone hydrogel contact lens for single use, daily disposable wear.
DEVICEFilcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Sponsors
Aston University
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate. * Require vision correction in both eyes. * Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction. * Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week. * Willing and able to wear study contact lenses 16 hours per day. * Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses. * Require monovision correction. * Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study. * Ocular surgery/trauma within the last 6 months. * Topical or systemic antibiotic use within 7 days of enrollment. * Topical ocular or systemic corticosteroid use within 14 days of enrollment. * Pregnant and nursing women. * Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) | Day 7, 16 hours after lens insertion | 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 corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time. |
Participant flow
Recruitment details
Participants were recruited from one study center in the United Kingdom.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| Overall DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 22.1 years STANDARD_DEVIATION 3.5 |
| Region of Enrollment United Kingdom | 39 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 18 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 / 39 | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 39 |
Outcome results
Primary
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
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 corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.
Time frame: Day 7, 16 hours after lens insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dailies Total 1 | Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) | 13.56 seconds | Standard Deviation 3.7759121 |
| TruEye | Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) | 12.0 seconds | Standard Deviation 2.9676727 |
| Clariti | Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) | 11.86 seconds | Standard Deviation 3.5982819 |