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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092907
• Other study ID #: 9036.1
• Status: Completed
• Phase: Phase 2
• Start date: March 22, 2019
• Est. completion date: July 10, 2019

Study information

• Verified date: July 2021
• Source: Harbour BioMed (Guangzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye

Description:

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 10, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or desire to use eye drops;

2. Have in the study eye a Schirmer's Test score of = 10 mm and = 1 mm at Visits 1 and 2;

3. Be willing and can adjust current treatment for dry eye according to the protocol, judged by the Investigator;

4. Must be willing to complete all study assessments required by the protocol.

Exclusion Criteria:

1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;

2. 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;

3. Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;

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	Qingdao Eye Hospital	Qingdao	Shandong

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	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)	8 weeks
Secondary	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)	8 weeks