Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)
| Group | Value | 95% CI |
|---|---|---|
| Lens A | 8.3 | ± 1.8 |
| Lens B | 8.8 | ± 1.2 |
Last reviewed · How we verify
Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
NA trial testing Lens A (comfilcon A lens) in Ametropia in 67 participants. Completed in 9 July 2022.
| Lead sponsor | CooperVision, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 31 January 2022 |
| Primary completion | 9 July 2022 |
| Estimated completion | 9 July 2022 |
| Sites | 4 locations across Canada, United States |
CooperVision, Inc.
Adults 18 to 35, any sex, with Ametropia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)
| Group | Value | 95% CI |
|---|---|---|
| Lens A | 8.3 | ± 1.8 |
| Lens B | 8.8 | ± 1.2 |
Time frame: From dispense up to one month on each study lens, for total of two months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lens A | Lens B |
|---|---|---|---|
| COVID-19 | Social circumstances | — | — |
| Lens discomfort | Product Issues | — | — |
| Sinus | Infections and infestations | — | — |
Data from ClinicalTrials.gov NCT05166902 adverse events section.
To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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