Refractive Error, Myopia
Conditions
Keywords
Contact lenses, Nearsightedness, Corneal curvature, K-reading, High minus, Spectacle refraction
Brief summary
The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.
Detailed description
Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.
Interventions
Commercially available silicone hydrogel contact lens
Commercially available silicone hydrogel contact lens
DEVICESpectacles
Incremental prescription worn over contact lenses if needed to provide acceptable vision
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent document; * Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D; * Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction); * Manifest astigmatism less than or equal to -1.00D; * Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Pregnant or lactating; * Eye injury or surgery within twelve weeks immediately prior to enrollment; * Any ocular condition that contraindicates contact lens wear; * History of herpetic keratitis; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops; * Clinical significant dry eye not responding to treatment; * Previous corneal or refractive surgery or irregular cornea; * Requires reading glasses; * Participation in a clinical trial (including contact lens or contact lens care product) within the previous 30 days; * Wears habitual lenses in an extended wear modality (routinely sleeps in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Central Corneal Curvature From Dispense at Week 1 | Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear) | Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 | Baseline, Week 1 (Day 8 of lens wear) | Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction. |
Participant flow
Recruitment details
Participants were recruited from 2 study centers located in the US and 2 study centers located in Germany.
Pre-assignment details
Of the 19 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (15).
Participants by arm
| Arm | Count |
|---|---|
| DAILIES TOTAL1/TRUEYE Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | DAILIES TOTAL1/TRUEYE |
|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Average Central Corneal Curvature From Dispense at Week 1
Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
Time frame: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)
Population: This analysis group includes all randomized participants with data present at visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DAILIES TOTAL1 | Change in Average Central Corneal Curvature From Dispense at Week 1 | -0.44 diopters | Standard Deviation 0.46 |
| TRUEYE | Change in Average Central Corneal Curvature From Dispense at Week 1 | -0.11 diopters | Standard Deviation 0.26 |
Secondary
Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1
Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.
Time frame: Baseline, Week 1 (Day 8 of lens wear)
Population: This analysis group includes all randomized participants with data present at visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DAILIES TOTAL1 | Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 | 3 Eyes |
| TRUEYE | Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 | 1 Eyes |