Trial | NCT04092907  Report issue

Title

A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye
A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of HBM9036 Ophthalmic Solution Versus Placebo in Subjects With Moderate to Severe Dry Eye

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Study Participants

    100
The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye
HBM9036 is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment.

A total of 100 subjects are expected to be randomized. Subjects will be randomized 1:1 at Visit 2 to HBM9036 Ophthalmic Solution or placebo group, bilaterally BID for eight weeks. The primary efficacy endpoint is sign changes from baseline in change from pre- to post-CAE inferior corneal staining score (ICSS) of the study eye evaluated at week 8 .
Study Started
Mar 22
2019
Primary Completion
Jul 03
2019
Study Completion
Jul 10
2019
Results Posted
Aug 11
2021
Last Update
Aug 11
2021

Drug HBM9036 0.25% Ophthalmic Solution

Ophthalmic Solution

Drug placebo

Ophthalmic Solution

HBM9036 0.25% Ophthalmic Solution Experimental

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

Placebo Ophthalmic Solution Placebo Comparator

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

Criteria 

Inclusion Criteria

Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or desire to use eye drops;
Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
Be willing and can adjust current treatment for dry eye according to the protocol, judged by the Investigator;
Must be willing to complete all study assessments required by the protocol.

Exclusion Criteria:

Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months, or had femtosecond small incision lenticule extraction (SMILE) within the last 12 months, or had phacoemulsification within the last 3 months, or had dry eye or aggravation of dry eye caused by other ocular operations has not been stable;
Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;

Summary

HBM9036 0.25% Ophthalmic Solution

Placebo Ophthalmic Solution

All Events

Event Type Organ System Event Term HBM9036 0.25% Ophthalmic Solution Placebo Ophthalmic Solution

Inferior Corneal Staining (ICS) Score

Inferior corneal staining score, assessed by Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale (0-4 point, higher is worse) Change from baseline in change from pre- to post- CAE at Visit 6 (higher is worse)

HBM9036 0.25% Ophthalmic Solution

1.8
units on a scale (Mean)
Standard Deviation: 0.44

Placebo Ophthalmic Solution

1.9
units on a scale (Mean)
Standard Deviation: 0.46

Ocular Discomfort Score

Ocular Discomfort Score, assessed by Ora Calibra® Ocular Discomfort Scale (0-4 point, higher is worse) Change from baseline in pre-CAE Ocular Discomfort Score at Visit 6 (higher is worse)

HBM9036 0.25% Ophthalmic Solution

2.94
units on a scale (Mean)
Standard Deviation: 0.791

Placebo Ophthalmic Solution

3.1
units on a scale (Mean)
Standard Deviation: 0.692

Total

100
Participants

Age, Continuous

42.6
years (Mean)
Standard Deviation: 10.25

Race and Ethnicity Not Collected

0
Participants

Sex: Female, Male

Overall Study

HBM9036 0.25% Ophthalmic Solution

Placebo Ophthalmic Solution