Qilu Pharmaceutical Launches Phase III Clinical Trial of Atropine Eye Drops (QLM3004) for Myopia Control in Children: A 735-Participant, Multicenter Study

Recently, Qilu Pharmaceutical registered a multicenter, randomized, open-label, placebo-controlled Phase III study (NCT06151587) on the Clinicaltrials.gov website, aiming to evaluate the efficacy and safety of different concentrations of atropine eye drops (QLM3004) in slowing the progression of myopia in children.

The study will be divided into two phases: the first phase is the primary efficacy and safety confirmation phase, and the second phase is the post-discontinuation observation phase.

Phase 1: During the 96-week treatment period, evaluate the safety and efficacy of three concentrations of QLM3004 compared to placebo in slowing the progression of myopia in children. Phase 2: The post-treatment observation period, which is not considered as a basis for verifying the efficacy and safety of QLM3004.

The study is expected to enroll 735 myopic children aged 6-12 years. The primary endpoint is the change in cycloplegic autorefraction spherical equivalent from baseline at week 96.

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