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

NCT04633213 | Completed Phase 3 DMC

• 1 other identifier: 9036.2
• Study Type: interventional
• Target: 577
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HBM9036 0.25% Ophthalmic Solution

EXPERIMENTAL

HBM9036, Ophthalmic Solution, twice a day, in the morning and evening

Drug: HBM9036 0.25% Ophthalmic Solution

Placebo Ophthalmic Solution

PLACEBO COMPARATOR

placebo, Ophthalmic Solution, twice a day, in the morning and evening

Drug: Placebo

Interventions

HBM9036 0.25% Ophthalmic Solution DRUG

Ophthalmic Solution

HBM9036 0.25% Ophthalmic Solution

Placebo DRUG

Ophthalmic Solution

Placebo Ophthalmic Solution

Eligibility Criteria

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

You may qualify if:

• At least 6 months history of any dry eye symptoms;
• 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;
• 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;
• At least 1 eye dryness score ≥ 40mm measured by 100mm Visual Analogue Scale (VAS) at Screening Visit;
• Schirmer's test score (anesthetized) ≥ 1mm and ≤ 10mm in the study eye at Screening Visit;
• Average tear film breakup time (TFBUT) ≤5 seconds in the study eye at Screening Visit;
• 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;
• Conjunctival redness score ≥1 according to the Ora Calibra Conjunctival Redness Scale at least in the study eye at Screening Visit.

You may not qualify if:

• 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;
• Currently active ocular infection (bacterial, viral, or fungal) or any ocular surface inflammation;
• 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;
• Planning to undergo any ocular or eyelid surgery;
• 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;
• Use of Cyclosporine A, Tacrolimus or Xiidra within 60 days prior to Screening Visit;
• History of HBM9036 (HL036) use;
• 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.

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

Study Sites (1)

Xiamen Eye Center of Xiamen University

Xiamen, Fujian, 361100, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Zuguo Liu, Doctor

  Xiamen Eye Center Affiliated to Xiamen University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: February 25, 2021
• Primary Completion: August 7, 2022
• Study Completion: August 7, 2022
• Last Updated: April 28, 2026

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)