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

NCT05515471 | Completed Phase 3

• 1 other identifier: SHR8058-301
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Treatment of Dry Eye Disease With Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Treatment group A: SHR8058 eye drops

EXPERIMENTAL

Drug: SHR8058 eye drops

Treatment group B: saline eye drops

PLACEBO COMPARATOR

Drug: saline eye drops.

Interventions

SHR8058 eye drops DRUG

SHR8058 eye drops

Treatment group A: SHR8058 eye drops

saline eye drops. DRUG

saline eye drops.

Treatment group B: saline eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed ICF (Informed Consent Form)
• Subject-reported history of Drye Eye Disease (DED) in both eyes
• Ability and willingness to follow instructions, including participation in all study assessments and visits

You may not qualify if:

• clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;
• Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
• underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;
• received or removed permanent lacrimal plug within 3 months before baseline;
• DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells;
• ocular or periocular malignancy;
• active ocular allergies, or allergy to the study drug or its components;
• ongoing ocular or systemic infection;
• use of contact lenses within 1 month before screening;
• intraocular surgery or ocular laser surgery within 6 months before enrollment;
• uncontrolled systemic disease or history of herpetic keratitis;
• use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical anti-glaucoma medication within 60 days before screening;
• used any known oral drugs that could have caused eye dryness within 1 month before screening;
• participated in or were participating in other clinical trials drugs or device within 60 days before baseline;
• inappropriate to participate for other reasons judged by the investigators.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• 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. 2025 Sep 2:1-7. doi: 10.1080/02713683.2025.2549289. Online ahead of print.

  PMID: 40898391 DERIVED

• 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.

  PMID: 36929413 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR8058 eye drops compared with placebo

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: February 4, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

CN (1)