An interventional study of Stenfilcon A contact lenses and Narafilcon A contact lenses in Refractive Error, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.
After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 66 is below the median of 82 across 296 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
Device: Stenfilcon A contact lenses · Device: Narafilcon A contact lenses
Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Device: Stenfilcon A contact lenses · Device: Narafilcon A contact lenses
Contact lenses worn during Period 1 or 2, as randomized
Also known as: MyDay™
Contact lenses worn during Period 1 or 2, as randomized
Also known as: 1-DAY ACUVUE® TruEye®
High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. 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
High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10
High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.
Time frame: Day 10, each product
Participants were enrolled from 1 investigative site located in the United Kingdom.
| Milestone | Habitual, MyDay, 1DAVTE | Habitual, 1DAVTE, MyDay |
|---|---|---|
| Started | 32 | 32 |
| Completed | 31 | 31 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Milestone | Habitual, MyDay, 1DAVTE | Habitual, 1DAVTE, MyDay |
|---|---|---|
| Started | 31 | 31 |
| Completed | 30 | 30 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Milestone | Habitual, MyDay, 1DAVTE | Habitual, 1DAVTE, MyDay |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. 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.
| VA unit | MyDay | 1DAVTE |
|---|---|---|
| High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 | 0.453 ± 0.673 | 0.341 ± 0.781 |
High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.
| VA unit | MyDay | 1DAVTE |
|---|---|---|
| High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10 | 0.614 ± 0.689 | 0.700 ± 0.777 |
Collected over Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | — | 0/66 (0%) | 0/66 (0%) |
| Dailies Total 1 | — | 0/32 (0%) | 5/32 (15.6%) |
| Clariti 1-Day | — | 0/32 (0%) | 0/32 (0%) |
| MyDay | — | 1/60 (1.7%) | 0/60 (0%) |
| 1DAVTE | — | 1/61 (1.6%) | 0/61 (0%) |
| Event | Pretreatment | Dailies Total 1 | Clariti 1-Day | MyDay | 1DAVTE |
|---|---|---|---|---|---|
| Kidney infectionInfections and infestations | 0/66 | 0/32 | 0/32 | 1/60 | 0/61 |
| Renal vein thrombosisRenal and urinary disorders | 0/66 | 0/32 | 0/32 | 0/60 | 1/61 |
| Event | Pretreatment | Dailies Total 1 | Clariti 1-Day | MyDay | 1DAVTE |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/66 | 2/32 | 0/32 | 0/60 | 0/61 |
| HordeolumInfections and infestations | 0/66 | 2/32 | 0/32 | 0/60 | 0/61 |
| Foreign body in eyeInjury, poisoning and procedural complications | 0/66 | 2/32 | 0/32 | 0/60 | 0/61 |
This reporting group includes all randomized participants.
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 33.8 ± 9.71 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 45 |
| Male | 19 |
No study locations are listed for this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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