NCT07394556

Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Indizen Optical Technologies, S.L.U. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The Goal of the study is to evaluate the rate of myopia progression with open ring myopia control spectacle lens designs compared to a commercial peripheral plus myopia control spectacle lens (CML) in European children with myopia. This is a prospective, randomized, bilateral wear, double masked, cross-over clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML). Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group will continue wearing CML for a further 12 months; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months

Conditions

• Myopia Progression

Interventions

Type	Name	Description
OTHER	myopia control lens	Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2028-10-01
• First posted: 2026-02-06
• Last updated: 2026-03-05

Locations

3 sites across 3 countries: Portugal, Spain, United Kingdom