Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.
| Group | Value | 95% CI |
|---|---|---|
| Control Lenses | -0.07 | ± 0.08 |
| Test Lenses | -0.13 | ± 0.08 |
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Clinical Evaluation of Reusable Soft Contact Lenses
NA trial testing Control Lenses (comfilcon A with current process) in Myopia in 77 participants. Completed in 1 March 2024.
| Lead sponsor | CooperVision International Limited (CVIL) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 14 November 2023 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 5 locations across United States |
CooperVision International Limited (CVIL) — full company profile →
18 and older, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.
| Group | Value | 95% CI |
|---|---|---|
| Control Lenses | -0.07 | ± 0.08 |
| Test Lenses | -0.13 | ± 0.08 |
Time frame: Length of study, approximately 30±2 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Control Lenses | Test Lenses |
|---|---|---|---|
| Ocular Hyperemia and Discomfort | Eye disorders | — | — |
Data from ClinicalTrials.gov NCT06119191 adverse events section.
The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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