Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease

NCT ID: NCT05841043

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2022-07-22

Brief Summary

The study is being conducted to assess the efficacy, safety and tolerability of SHR8028 eye drops in comparison to the vehicle for the treatment of dry eye disease.

Conditions

Dry Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SHR8028 eye drops

Group Type: EXPERIMENTAL

SHR8028 eye drops

Intervention Type: DRUG

SHR8028 eye drops

Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle eye drops.

Intervention Type: DRUG

Vehicle eye drops.

Interventions

SHR8028 eye drops

SHR8028 eye drops

Intervention Type: DRUG

Vehicle eye drops.

Vehicle eye drops.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old;

2. Provide written informed consent form;

3. Have a subject reported history of dry eye disease in both eyes for at least 180 days before the screening visit (visit 0);

4. Be currently (within 30 days before visit 0) using over-the-counter (OTC) eye drops, lubricating gels or tear neurostimulator device (such as True TearTM), and/or artificial tears for dry eye symptoms;

5. Have at least one eye meets criteria of moderate to severe dry eye both at visit 0&1

6. Be able and willing to follow instructions and participate in all study assessments and visits.

Exclusion Criteria

1. Have any clinically significant slit-lamp findings at visit 0 that require treatment with prescription drugs and/or in the opinion of the investigator may interfere with study parameters, such as trauma, Stevens-Johnson syndrome, or advanced epithelial basement membrane disease;

2. Have dry eye disease secondary to scar formation, such as radiation, alkali burn, cicatricial pemphigus, and destruction of conjunctival goblet cells (i.e., destruction of conjunctival goblet cells caused by vitamin A deficiency);

3. Have active ocular allergy or ocular allergy that may occur during the study;

4. Be diagnosed with an ongoing ocular or systemic infection (bacterial, viral, or fungal), including fever, or be undergoing treatment with antibiotics at visit 0 and visit 1;

5. Be a woman who is pregnant, breastfeeding, or planning pregnancy;

6. Have an uncontrolled systemic disease;

7. Have allergies to investigational medicinal product (IMP) or its components: cyclosporin A or semi-fluorinated alkanes (SFA);

8. Be currently participating in other drug or device trials, or have used other investigational drugs or devices within 60 days before visit 0;

9. Have a condition which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere with the subject's participation in the study significantly;

10. Have received or removed lacrimal duct embolism within 90 days before visit 0, or plan to receive or remove lacrimal duct embolism during the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Peng R, Jie Y, Long Q, Gong L, Zhu L, Zhong X, Zhao S, Yan X, Gu H, Wu H, Li G, Zhang K, Krosser S, Xu R, Hong J. Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2024 Apr 1;142(4):337-343. doi: 10.1001/jamaophthalmol.2024.0101.

Reference Type: DERIVED

PMID: 38451509 (View on PubMed)

Other Identifiers

SHR8028-301

Identifier Type: -

Identifier Source: org_study_id