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Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

Study acronym: SLOMES
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Apr 23, 2027 to May 4, 2027
    • Study completion date: Apr 30, 2027 to May 4, 2027
    v8
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Feb 28, 2027 to Apr 23, 2027
    • Study completion date: Mar 31, 2027 to Apr 30, 2027
    • Secondary endpoints: details revised at 7 of 10 entries
    • Site details revised at 3 of 3 sites
  4. Primary completion date: Sep 30, 2026 to Feb 28, 2027
    • Study completion date: Dec 30, 2026 to Mar 31, 2027
    • Site details revised at 3 of 3 sites
    v5
  5. Site details revised at 1 of 3 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Mar 1, 2024 to Mar 22, 2024
    v3
  2. Start date: Feb 15, 2024 to Mar 1, 2024
    • Study title expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline.
Trial Details
NCT Number NCT06263946
Lead Sponsor Essilor International
Conditions
(from sponsor)		 Myopia
Related terms Myopia
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov