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Terminated NCT05840185

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (DAL)

Conditions: Myopia

Sex: All
Ages: 8 Years – 13 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 41
Sponsor: Essilor International

Location: Essilor R&D Centre Singapore Singapore

Summary

This is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial NCT05331378. A total of 40 children will be recruited

Eligibility Criteria

Inclusion Criteria: * Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form. * 8 to 13 years old at time of informed consent and assent. * Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye. * Astigmatism, if present, of not more than 1.50 D. * Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D. * Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen) * Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status. * Absence of strabismus by cover test at near or distance wearing correction. * Absence of amblyopia * Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. Exclusion Criteria: * Vulnerability of subject * History of myopia control intervention * Participation in any clinical study within 30 days of the Baseline visit.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05840185). StuddyBuddy aggregates publicly available trial information.