An interventional study of Lens 1 (monthly replacement) and Lens 2 (daily disposable) in Myopia and Hyperopia, sponsored by CooperVision, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by CooperVision, Inc. · Not applicable, Interventional, and Treatment
The study objective was to gather short-term clinical performance data for two soft contact lenses.
The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.
140 studies on the registry are indexed under Hyperopia; 18 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 112 interventional studies indexed under Hyperopia.
Browse Hyperopia 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.
Exclusion Criteria:
All participants wore Lens 1 for 15 minutes (Period 1)
Device: Lens 1 (monthly replacement)
All participants wore Lens 2 for 15 minutes (Period 2)
Device: Lens 2 (daily disposable)
Monthly replacement spherical silicone hydrogel contact lens for 15 minutes
Daily disposable spherical silicone hydrogel contact lens for 15 minutes
Subjective Overall Score
Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall
Time frame: 15 minutes
Subjective Comfort
Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt
Time frame: 15 minutes
Subjective Vision
Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss
Time frame: 15 minutes
| Milestone | Lens 1 (Monthly Replacement) | Lens 2 (Daily Disposable) |
|---|---|---|
| Started | 45 | 0 |
| Completed | 45 | 0 |
| Not completed | 0 | 0 |
| Milestone | Lens 1 (Monthly Replacement) | Lens 2 (Daily Disposable) |
|---|---|---|
| Started | 0 | 45 |
| Completed | 0 | 45 |
| Not completed | 0 | 0 |
Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall
| score on a scale | Lens 1 | Lens 2 |
|---|---|---|
| Subjective Overall Score | 84.7 ± 15.5 | 82.5 ± 14.6 |
Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt
| score on a scale | Lens 1 | Lens 2 |
|---|---|---|
| Subjective Comfort | 86.4 ± 16.4 | 86.6 ± 13.5 |
Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss
| score on a scale | Lens 1 | Lens 2 |
|---|---|---|
| Subjective Vision | 85.8 ± 14.9 | 82.7 ± 15.9 |
Collected over The duration of the clinical trial, approximately 1.5 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lens 1 | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Lens 2 | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Age, Continuous(years) | Overall Study |
|---|---|
| Female | 32.4 ± 11.9 |
| Male | 37.3 ± 15.0 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 28 |
| Male | 17 |
| Race and Ethnicity Not Collected(Participants) | Overall Study |
|---|
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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CooperVision, Inc.