Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction

Summary

The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.

Timeline

Start

2021-02-04

Primary completion

2021-09-07

Completion

2021-09-07

Outcome

Met primary endpoint

paper Both primary end points were achieved PMID 36929413 ↗

release “SHR8058-301 evaluated its primary efficacy at eight weeks. 2 The trial met its prespecified primary sign endpoint improvement of total corneal fluorescein staining” novaliq.com ↗

Publications

• Zhu Y, Xie J, Shi X, Sun Y. Perfluorohexyloctane Eye Drops in Premenopausal and Postmenopausal Women with Dry Eye Disease Associated with Meibomian Gland Dysfunction: A Post Hoc Analysis of a Phase 3 Trial. Curr Eye Res. 2026 Jan;51(1):9-15. doi: 10.1080/02713683.2025.2549289. Epub 2025 Sep 2.
• Tian L, Gao Z, Zhu L, Shi X, Zhao S, Gu H, Xu G, Wang L, Dai H, Zhang H, Jin X, Ma K, Xu Y, Ma L, Pei C, Ke B, Krosser S, Zhang Y, Jie Y. Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Apr 1;141(4):385-392. doi: 10.1001/jamaophthalmol.2023.0270.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHR8058	Unknown	—	Other

Indications

No indication recorded.