QLS-111 Ophthalmic Solution for Glaucoma

((PENGUIN) Trial)

This trial explores a new eye drop solution, QLS-111, to determine its effectiveness in managing glaucoma and diabetic eye conditions. The researchers aim to assess whether this treatment can lower eye pressure and improve vision in individuals with mild to moderate open-angle glaucoma, normal-tension glaucoma, or stable non-proliferative diabetic retinopathy. Participants will apply the eye drops twice daily for seven days, with the study comparing two different concentrations. Ideal participants have been diagnosed with one of these eye conditions and can read the top line of an eye chart with corrected vision. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop all current medications, but you cannot use more than one eye pressure-lowering medication or certain other treatments like TO β-blockers, anti-VEGF, or TO steroids within 3 months before starting the trial. It's best to discuss your specific medications with the trial team.

Research has shown that QLS-111 Eye Drops are safe and well-tolerated by patients. In studies, all tested doses of QLS-111, including those used in this trial, demonstrated excellent safety results. Importantly, no serious side effects occurred. Patients did not experience stinging, burning, or other eye-related issues when using the drops. These findings suggest that QLS-111 is a safe choice for those considering joining this trial.¹²³⁴⁵

Unlike the standard treatments for glaucoma, which typically include prostaglandin analogs or beta-blockers, QLS-111 Ophthalmic Solution is unique because it combines two concentrations (0.015% and 0.075%) in one formulation. This dual-concentration approach, administered twice daily, could potentially enhance treatment efficacy by optimizing the balance between potency and tolerability. Researchers are excited about QLS-111 because it promises faster results, potentially showing improvements in just seven days, compared to several weeks for current options. Additionally, the convenience of using a single eye drop solution with dual concentrations may improve patient compliance and overall treatment outcomes.

Research has shown that QLS-111 Eye Drops could help treat glaucoma. In earlier studies, QLS-111 combined with latanoprost (a common glaucoma medication) lowered eye pressure by up to 3.6 mmHg more than latanoprost alone. Additionally, patients using a low dose of QLS-111 experienced an average daily eye pressure reduction of more than 20%. Lowering eye pressure is crucial because it can help prevent vision loss in people with glaucoma. This trial will evaluate two concentrations of QLS-111 Ophthalmic Solution, administered twice daily, to further assess its potential as a treatment option for those with normal tension glaucoma or open-angle glaucoma.¹²⁵⁶⁷