An interventional study of Lens A and Lens B in Myopia and Hyperopia, sponsored by CooperVision, Inc.. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by CooperVision, Inc. (part of CooperCompanies) · Not applicable, Interventional, and Treatment
This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.
The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.
1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 803 interventional studies indexed under Myopia.
Browse Myopia studies →CooperVision, Inc. is the lead sponsor of 38 studies on the registry; none are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 30 (94%) have results posted.
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Exclusion Criteria:
All participants wore Lens A for 15 minutes (Period 1)
Device: Lens A
All participants wore Lens B for 15 minutes (Period 2)
Device: Lens B
Soft spherical hydrogel contact lens for 15 minutes
Soft spherical silicone hydrogel contact lens for 15 minutes
Lens Fit Acceptance Rating
Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.
Time frame: 15 minutes
| Milestone | Lens A (Hydrogel Contact Lens) | Lens B (Silicone Hydrogel Contact Lens) |
|---|---|---|
| Started | 40 | 0 |
| Completed | 40 | 0 |
| Not completed | 0 | 0 |
| Milestone | Lens A (Hydrogel Contact Lens) | Lens B (Silicone Hydrogel Contact Lens) |
|---|---|---|
| Started | 0 | 40 |
| Completed | 0 | 40 |
| Not completed | 0 | 0 |
Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.
| score on a scale | Lens A | Lens B |
|---|---|---|
| Lens Fit Acceptance Rating | 3.28 ± 0.60 | 3.48 ± 0.60 |
Collected over From dispense up to 15 minutes on each lens type, approximately 1.5 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lens A | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Lens B | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 24.68 ± 4.57 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 31 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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