0.1% Tβ4 Ophthalmic Solution for Dry Eye Symptoms and Signs

This study is about evaluating the safety and effectiveness of a treatment called Tβ4 Ophthalmic Solution for dry eye syndrome. Dry eye syndrome is a condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to discomfort and vision problems. Tβ4 is a substance that promotes wound repair and regeneration in various tissues, including the eye. It has shown promising results in repairing corneal wounds and reducing corneal staining in nonclinical studies and compassionate-use cases. This study aims to further explore its potential in treating dry eye syndrome, targeting individuals suffering from this condition. The study's outcomes could potentially lead to a new safe and effective therapeutic option for dry eye syndrome. During the study, participants will receive either the Tβ4 Ophthalmic Solution or a placebo (a solution with no active ingredients). The treatment will be administered as eye drops. The study will take place in a controlled adverse environment, a regulated setting designed to exacerbate dry eye signs and symptoms. Two primary outcomes will be measured: corneal staining in the worst eye and ocular discomfort in the worst eye. Corneal staining will be tested using a special dye and light, while ocular discomfort will be measured using a validated 4-point scale. Both tests will be conducted throughout the study until the end of treatment on Day 29. The 'worst eye' is determined as the eye with the greater increase of inferior corneal staining or ocular discomfort. If both eyes are equal, the right eye is chosen as the worst eye.