NCT04092907

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 11, 2021

Completed
Last Updated

August 11, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

September 9, 2019

Results QC Date

June 28, 2021

Last Update Submit

July 20, 2021

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ocular Discomfort Score

    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 SolutionDRUG

Ophthalmic Solution

HBM9036 0.25% Ophthalmic Solution
placeboDRUG

Ophthalmic Solution

Placebo Ophthalmic Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingdao Eye Hospital

Qingdao, Shandong, 266000, China

Location

Related Publications (1)

  • Dong Y, Wang S, Cong L, Zhang T, Cheng J, Yang N, Qu X, Li D, Zhou X, Wang H, Lee M, Wang M, Chen S, Ousler GW, Chen X, Xie L. TNF-alpha inhibitor tanfanercept (HBM9036) improves signs and symptoms of dry eye in a phase 2 trial in the controlled adverse environment in China. Int Ophthalmol. 2022 Aug;42(8):2459-2472. doi: 10.1007/s10792-022-02245-1. Epub 2022 Feb 22.

    PMID: 35192105DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

Title
Nina Shen
Organization
Harbour Biomed
nina.shen@harbourbiomed.com
18251811067

Study Officials

  • Lixin XIE, Academician

    QINGDAO EYE HOSPITAL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
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

September 9, 2019

First Posted

September 17, 2019

Study Start

March 22, 2019

Primary Completion

July 3, 2019

Study Completion

July 10, 2019

Last Updated

August 11, 2021

Results First Posted

August 11, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)