An interventional study of Senofilcon A; Comfilcon A and Comfilcon A; Senofilcon A in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by CooperVision International Limited (CVIL) · Not applicable, Interventional, and Other
Evaluation of Comfilcon A and Senofilcon A Lenses
Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 9 are open to participants now.
Of its 72 completed or terminated interventional studies of FDA-regulated products, 67 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must satisfy the following conditions prior to inclusion in the study:
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Exclusion Criteria:
Any of the following will render a subject ineligible for inclusion:
Senofilcon A; Comfilcon A
Device: Senofilcon A; Comfilcon A · Device: Comfilcon A; Senofilcon A
Comfilcon A; Senofilcon A
Device: Senofilcon A; Comfilcon A · Device: Comfilcon A; Senofilcon A
Senofilcon A; Comfilcon A
Comfilcon A; Senofilcon A
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)
Time frame: Baseline Insertion, 10 Minutes, 5 hours and 10 hours
| Milestone | Overall Study Participants |
|---|---|
| Started | 61 |
| Completed | 61 |
| Not completed | 0 |
Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)
| units on a scale | Comfilcon A | Senofilcon A |
|---|---|---|
| Baseline Insertion | 86 ± 15 | 87 ± 13 |
| 10 Minutes | 89 ± 14 | 91 ± 12 |
| 5 Hours | 83 ± 19 | 84 ± 18 |
| 10 Hours | 79 ± 23 | 81 ± 21 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study Participants | — | 0/61 (0%) | 0/61 (0%) |
| Comfilcon A | — | 0/61 (0%) | 0/61 (0%) |
Subjects
| Age, Customized(eyes) | Overall Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 61 |
| >=65 years | 0 |
| Age, Continuous(years) | Overall Study Participants |
|---|---|
| Mean | 26 ± 6 |
| Sex: Female, Male(Participants) | Overall Study Participants |
|---|---|
| Female | 38 |
| Male | 23 |
| Region of Enrollment(participants) | Overall Study Participants |
|---|---|
| United States | 61 |
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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CooperVision International Limited (CVIL)