An interventional study of Lens A (fanfilcon A) and Lens B (asmofilcon A) in Astigmatism and Myopia, sponsored by CooperVision, Inc.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by CooperVision, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each.
This was a prospective, randomized, double masked, bilateral, crossover study. Participants were expected to attend 6 scheduled visits over a period of approximately 2 months.
413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.
This study's enrollment of 36 is below the median of 55 across 321 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →CooperVision, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 29 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
Participants wore Lens A for one month and then wore Lens B for one month.
Device: Lens A (fanfilcon A) · Device: Lens B (asmofilcon A)
Participants wore Lens B for one month and then wore Lens A for one month.
Device: Lens A (fanfilcon A) · Device: Lens B (asmofilcon A)
Daily wear for one month
Daily wear for one month
Lens Handling (Insertion and Removal)
Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.
Time frame: 1 month
This study was conducted at a single investigative site located in Mexico City, Mexico.
| Milestone | Lens A, Then Lens B | Lens B, Then Lens A |
|---|---|---|
| Started | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 0 |
| Milestone | Lens A, Then Lens B | Lens B, Then Lens A |
|---|---|---|
| Started | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 0 |
Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.
| units on a scale | Lens A | Lens B |
|---|---|---|
| Lens Handling (Insertion and Removal) | 9.47 ± 1.00 | 8.33 ± 1.54 |
Collected over For the duration of the study, approximately two months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lens A | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Lens B | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 28.6 ± 6.8 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 28 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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CooperVision, Inc.