Status:
COMPLETED
A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye
Lead Sponsor:
Harbour BioMed (Guangzhou) Co. Ltd.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Detailed 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 Oph...
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
March 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04092907
Start Date
March 22 2019
End Date
July 10 2019
Last Update
August 11 2021
Active Locations (1)
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1
Qingdao Eye Hospital
Qingdao, Shandong, China, 266000