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

• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04092907
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 27.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: HBM9036 0.25% Ophthalmic Solution; Drug: placebo	Phase 2

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 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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 22, 2019
• Actual Primary Completion Date: Jul 3, 2019
• Actual Study Completion Date: Jul 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HBM9036 0.25% Ophthalmic Solution HBM9036, Ophthalmic Solution, twice a day, in the morning and evening	Drug: HBM9036 0.25% Ophthalmic Solution; Ophthalmic Solution
Placebo Comparator: Placebo Ophthalmic Solution placebo, Ophthalmic Solution, twice a day, in the morning and evening	Drug: placebo; Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

1. Inferior Corneal Staining (ICS) Score [8 weeks]

   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)

Secondary Outcome Measures

1. Ocular Discomfort Score [8 weeks]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qingdao Eye Hospital	Qingdao	Shandong	China	266000

Sponsors and Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.

Investigators

• Principal Investigator: Lixin XIE, Academician, QINGDAO EYE HOSPITAL

Study Documents (Full-Text)

• Study Protocol - Jan 9, 2019
• Statistical Analysis Plan - Jul 10, 2019
• Informed Consent Form - Jan 9, 2019

More Information

Publications

None provided.

• Responsible Party: Harbour BioMed (Guangzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04092907
• Other Study ID Numbers: 9036.1
• First Posted: Sep 17, 2019
• Last Update Posted: Aug 11, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	HBM9036 0.25% Ophthalmic Solution	Placebo Ophthalmic Solution
Arm/Group Description	HBM9036, Ophthalmic Solution, twice a day, in the morning and evening	placebo, Ophthalmic Solution, twice a day, in the morning and evening
Period Title: Overall Study
STARTED	50	50
COMPLETED	48	50
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	HBM9036 0.25% Ophthalmic Solution	Placebo Ophthalmic Solution	Total
Arm/Group Description	HBM9036, Ophthalmic Solution, twice a day, in the morning and evening HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution	placebo, Ophthalmic Solution, twice a day, in the morning and evening placebo: Ophthalmic Solution	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.4 (11.19)	43.9 (9.15)	42.6 (10.25)
Sex: Female, Male (Count of Participants)
Female	25 50%	32 64%	57 57%
Male	25 50%	18 36%	43 43%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Inferior Corneal Staining (ICS) Score
Description	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)
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

The analysis population is per-protocol population, which excluded a few patients.

Arm/Group Title	HBM9036 0.25% Ophthalmic Solution	Placebo Ophthalmic Solution
Arm/Group Description	HBM9036, Ophthalmic Solution, twice a day, in the morning and evening HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution	placebo, Ophthalmic Solution, twice a day, in the morning and evening placebo: Ophthalmic Solution
Measure Participants	47	48
Mean (Standard Deviation) [units on a scale]	1.8 (0.44)	1.9 (0.46)

2. Secondary Outcome

Title	Ocular Discomfort Score
Description	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)
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HBM9036 0.25% Ophthalmic Solution	Placebo Ophthalmic Solution
Arm/Group Description	HBM9036, Ophthalmic Solution, twice a day, in the morning and evening HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution	placebo, Ophthalmic Solution, twice a day, in the morning and evening placebo: Ophthalmic Solution
Measure Participants	47	48
Mean (Standard Deviation) [units on a scale]	2.94 (0.791)	3.10 (0.692)

Adverse Events

Time Frame	From start of the first study drug administration up to Day 57 or Early termination (ET)
Adverse Event Reporting Description	Adverse events that occurred after the start of first dose administration are considered treatment emergent adverse and summarized by treatment arm. A participant (subject) is counted only once for the same adverse event, regardless of the number of episodes.
Arm/Group Title	HBM9036 0.25% Ophthalmic Solution		Placebo Ophthalmic Solution
Arm/Group Description	HBM9036, Ophthalmic Solution, twice a day, in the morning and evening HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution		placebo, Ophthalmic Solution, twice a day, in the morning and evening placebo: Ophthalmic Solution
All Cause Mortality
	HBM9036 0.25% Ophthalmic Solution		Placebo Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Serious Adverse Events
	HBM9036 0.25% Ophthalmic Solution		Placebo Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	HBM9036 0.25% Ophthalmic Solution		Placebo Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/50 (28%)		14/50 (28%)
Ear and labyrinth disorders
Ear discomfort	1/50 (2%)		0/50 (0%)
Eye disorders
Conjunctival hyperemia	3/50 (6%)		0/50 (0%)
Eye pruritus	1/50 (2%)		1/50 (2%)
Allergic conjunctivitis	1/50 (2%)		0/50 (0%)
Lacrimation increased	1/50 (2%)		0/50 (0%)
Ocular pain	1/50 (2%)		0/50 (0%)
Visual fatigue	1/50 (2%)		0/50 (0%)
Ocular hyperemia	0/50 (0%)		1/50 (2%)
Blurred vision	0/50 (0%)		1/50 (2%)
Visual impairment	0/50 (0%)		1/50 (2%)
Gastrointestinal disorders
Mouth ulcers	1/50 (2%)		0/50 (0%)
toothache	0/50 (0%)		1/50 (2%)
gastritis	0/50 (0%)		1/50 (2%)
General disorders
Chest discomfort	0/50 (0%)		1/50 (2%)
Immune system disorders
Seasonal allergies	0/50 (0%)		1/50 (2%)
Infections and infestations
Conjunctivitis	3/50 (6%)		0/50 (0%)
Upper respiratory tract infection	5/50 (10%)		5/50 (10%)
Local infection	1/50 (2%)		0/50 (0%)
Injury, poisoning and procedural complications
Skin trauma	0/50 (0%)		1/50 (2%)
Sprained ligament	0/50 (0%)		1/50 (2%)
Musculoskeletal and connective tissue disorders
backache	1/50 (2%)		0/50 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/50 (2%)		0/50 (0%)
cough	1/50 (2%)		0/50 (0%)
Dry throat	1/50 (2%)		0/50 (0%)
rhinobyon	1/50 (2%)		0/50 (0%)
Rhinorrhea	1/50 (2%)		0/50 (0%)
Skin and subcutaneous tissue disorders
Subepidermal hemorrhage	0/50 (0%)		1/50 (2%)
Allergic dermatitis	0/50 (0%)		1/50 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.