Astigmatism
Conditions
Keywords
DACP Toric, DAILIES® AquaComfort Plus®, Astigmatism, Toric
Brief summary
The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).
Interventions
Sponsors
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
* Must sign an Informed Consent document; * Wear toric soft contact lenses within the protocol-specified range; * Cylinder equal or higher than -0.75 diopters (D) in both eyes; * Have an acceptable fit with both study contact lenses; * Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible; * Best corrected visual acuity (BCVA) of 20/30 Snellen; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear; * Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * Require presbyopic correction; * Any ocular condition observed during examination at the enrollment visit; * History of herpetic keratitis, ocular surgery or irregular cornea; * Pregnant or lactating; * Participation in any clinical trial within 30 days of the enrollment visit; * Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 | Day 10, each product | TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Oscillation at Blink at Day 10 | Day 10, each product | Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only. |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in the US and 1 study center located in the UK.
Pre-assignment details
This reporting group includes all enrolled participants, as treated. Note: 2 participants randomized to DACP T were exited prior to dispense due to unacceptable fit (1) and unavailable lens power (1).
Participants by arm
| Arm | Count |
|---|---|
| Overall Nelfilcon A and Etafilcon A toric contact lenses worn during Period 1 and Period 2, as randomized, in a crossover assignment. | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: First 10 Days | Unacceptable lens fit | 1 | 0 |
| Period 1: First 10 Days | Unavailable lens power | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 79 | 0 / 78 |
| serious Total, serious adverse events | 0 / 79 | 0 / 78 |
Outcome results
Primary
High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
Time frame: Day 10, each product
Population: This analysis group includes all randomized subjects who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DACP T | High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 | 0.02 VA units | Standard Deviation 0.94 |
| 1DAM A | High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 | 0.04 VA units | Standard Deviation 0.92 |
Secondary
Lens Oscillation at Blink at Day 10
Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.
Time frame: Day 10, each product
Population: This analysis group includes all randomized subjects at the UK site with data at visit who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DACP T | Lens Oscillation at Blink at Day 10 | Left Eye | 2.1 degrees | Standard Deviation 1 |
| DACP T | Lens Oscillation at Blink at Day 10 | Right Eye | 2.1 degrees | Standard Deviation 1 |
| 1DAM A | Lens Oscillation at Blink at Day 10 | Left Eye | 2.5 degrees | Standard Deviation 0.8 |
| 1DAM A | Lens Oscillation at Blink at Day 10 | Right Eye | 2.7 degrees | Standard Deviation 1.1 |