Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR8058 eye drops | Experimental |
| |
| Treatment group B: saline eye drops | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8058 eye drops | Drug | SHR8058 eye drops |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57 | The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section). | Baseline, Day 57 |
| Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57 | Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness"). | Baseline, Day 57 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40898391 | Derived | 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. | |
| 36929413 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SHR8058 eye drops compared with placebo
Not provided
Not provided
Not provided
| saline eye drops. |
| Drug |
saline eye drops. |
|
| 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. |