NCT06305663 A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
| NCT ID | NCT06305663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bausch & Lomb Incorporated |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 418 participants |
| Start Date | 2024-03-29 |
| Primary Completion | 2027-01-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
Eligibility Criteria
Inclusion Criteria: 1. Male or female aged 8 to 12 years plus 11 months old on the date the Informed Assent and Parental or Guardian Informed Consent are signed and have capacity to provide voluntary informed consent. 2. Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening: 1. Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive. 2. Astigmatism: ≤ -0.75 D. c. Anisometropia: \< 1.00 D. 3. Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye. 4. Subject must have distance best-spectacle corrected visual acuity (BSCVA) by non-cycloplegic manifest refraction of +0.04 logMAR (20/20 Snellen equivalent) or better in each eye. 5. Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment. 6. Subject agrees to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the du