Abstract
Glaucoma leads to irreversible blindness. Numerous anti-glaucoma eye drops have been developed. Unfortunately, many patients with glaucoma still suffer from progressive visual disorders. Recently, ripasudil hydrochloride hydrate, a selective Rho-associated protein kinase inhibitor, was launched for the treatment of glaucoma. However, adverse events, such as conjunctival hyperemia, are often noted in clinical trials using healthy subjects. Therefore, we investigated the onset, offset, and kinetic changes of conjunctival hyperemia induced by ripasudil ophthalmic solution in patients with open-angle glaucoma or ocular hypertension who had already been treated with anti-glaucoma eye drops other than ripasudil. Conjunctival hyperemia was evaluated by both clinical grading by 3 ophthalmic physicians and pixel coverage of conjunctival blood vessels determined by conjunctival hyperemia-analyzing software. Conjunctival hyperemia appeared within 10 min post-instillation in most of the participants. Clinical grade and pixel coverage increased significantly 10 min post-instillation and then decreased. In most of the participants, hyperemia resolved within 2 h. Median conjunctival hyperemia offset was 90 min. A tendency of monotonic increase was observed between clinical grade and pixel coverage. Taken altogether, hyperemia induced by ripasudil was transient in glaucoma patients who had already been treated with anti-glaucoma eye drops other than ripasudil.
Highlights
IntroductionRipasudil hydrochloride hydrate, a selective Rho-associated protein kinase inhibitor, was launched for the treatment of glaucoma
Honrubia et al reported that the incidences of hyperemia related to use of prostaglandin analog ophthalmic solutions were 3.3% to 71.4%6
Using automated hyperemia analysis software[7], Yanagi et al compared the severity of hyperemia resulting from use of various types of anti-glaucoma eye drops and concluded that prostaglandin analogs were most likely to induce hyperemia
Summary
Ripasudil hydrochloride hydrate, a selective Rho-associated protein kinase inhibitor, was launched for the treatment of glaucoma Adverse events, such as conjunctival hyperemia, are often noted in clinical trials using healthy subjects. We investigated the onset, offset, and kinetic changes of conjunctival hyperemia induced by ripasudil ophthalmic solution in patients with openangle glaucoma or ocular hypertension who had already been treated with anti-glaucoma eye drops other than ripasudil. A recent clinical trial with 51 healthy participants investigated changes in conjunctival hyperemia and reduction of IOP within 2 h (at 5, 15, 30, 60, 120 min) post-instillation of 0.4% ripasudil[5]. Ripasudil-induced changes in conjunctival hyperemia over time have not been investigated in patients with glaucoma, who were previously treated with anti-glaucoma eye drops, other than ripasudil. We evaluated the offset of conjunctival hyperemia, induced by ripasudil, in patients with open-angle glaucoma or ocular hypertension (OHT)
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