A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye

Dry Eye Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blinded and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HBM9036 (HL036) Ophthalmic Solution Compared to Placebo in Chinese Subjects With Moderate and Severe Dry Eye

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04633213
• Other study ID #: 9036.2
• Status: Recruiting
• Phase: Phase 3
• Start date: February 24, 2021
• Est. completion date: April 7, 2023

Study information

• Verified date: June 2022
• Source: Harbour BioMed (Guangzhou) Co. Ltd.
• Contact: Zuguo Liu, Doctor
• Phone: 86-18959289999
• Email: zuguoliu[@]xmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the safety and efficacy of 0.25% HBM9036 (HL036) Ophthalmic Solution to placebo for the treatment of the Chinese subjects with moderate and severe dry eye.

Description:

Inhibitors for tumor necrosis factor (TNF) have been widely used in clinical practice. Such class of medications have been approved for rheumatoid arthritis, ulcerative colitis, and uveitis. HBM9036 (HL036) is a molecularly engineered TNFR1 fragment, and molecule fragmentation and engineering techniques are applied for enhanced tissue distribution, increased stability and potency. In multiple early stage studies including preclinical studies, HBM9036 (HL036) has demonstrated the safety and efficacy in the therapy for moderate and severe dry eye. As a phase 3 confirmational study, this study is to evaluate the safety and efficacy of 0.25% HBM9036 (HL036) ophthalmic solution compared to placebo in Chinese subjects with moderate and severe dry eye.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 674
• Est. completion date: April 7, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 6 months history of any dry eye symptoms;

2. Must use or feel the need to use any types of eye drops to treat dry eye disease symptoms within 6 months prior to Screening Visit;

3. Best corrected visual acuity (BCVA) = logMAR+0.7 as assessed according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Screening Visit;

4. At least 1 eye dryness score = 40mm measured by 100mm Visual Analogue Scale (VAS) at Screening Visit;

5. Schirmer's test score (anesthetized) = 1mm and = 10mm in the study eye at Screening Visit;

6. Average tear film breakup time (TFBUT) =5 seconds in the study eye at Screening Visit;

7. Total corneal fluorescein staining score = 5.5 according to the Ora Calibra Corneal and Conjunctival Staining Scale at least in the study eye at Screening and Baseline Visits;

8. Conjunctival redness score =1 according to the Ora Calibra Conjunctival Redness Scale at least in the study eye at Screening Visit.

Exclusion Criteria:

1. At Screening Visit, Subjects observed by investigator with any clinically significant signs including active blepharitis and ocular allergies. Patients with meibomian gland dysfunction that need treatment;

2. Currently active ocular infection (bacterial, viral, or fungal) or any ocular surface inflammation;

3. Patients whose dry eye disease secondary to Sjogren's syndrome, Steven-Johnson Syndrome or chronic graft versus host disease, or patients suffered from serious autoimmune disorders such as systemic lupus erythematosus or rheumatoid arthritis, If their systemic disease are instable or drug application changed such as the type or dose of immunosuppressive biologics had been adjusted within 3 months or had drug withdrawal within 1 month or expected to have their drugs adjusted or discontinued during the study;

4. Planning to undergo any ocular or eyelid surgery;

5. Patients suffered from insertion of temporary lacrimal plug surgery within 6 months or insertion of permanent lacrimal plug surgery within 3 months. Or planning to undergo insertion of lacrimal plug surgery during the study;

6. Use of Cyclosporine A, Tacrolimus or Xiidra within 60 days prior to Screening Visit;

7. History of HBM9036 (HL036) use;

8. Currently use of prescription (including but not limited to antiglaucoma drops) or OTC drugs that locally applied to eyes, artificial tears, ophthalmic gel and eye rinse that cannot be interrupted during the study (excluding medications allowed in this study); pharmacological wash-out periods are required for some drugs.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• HBM9036 0.25% Ophthalmic Solution
Ophthalmic Solution
• Placebo
Ophthalmic Solution

Locations

Country	Name	City	State
China	Xiamen Eye Center of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Harbour BioMed (Guangzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total corneal staining scores (upper, central and lower cornea) of the study eye	Total corneal staining score (TCSS; superior, central, and inferior regions) of study eye evaluated by Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining at Visit 5/Day 57, change from baseline Score: From 0-12, a higher score means a worse outcome.	8 weeks