Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye (NCT NCT04092907)

Last Updated: 2021-08-11

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	HBM9036 0.25% Ophthalmic Solution HBM9036, Ophthalmic Solution, twice a day, in the morning and evening	Placebo Ophthalmic Solution placebo, Ophthalmic Solution, twice a day, in the morning and evening
Overall Study STARTED	50	50
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HBM9036 0.25% Ophthalmic Solution n=50 Participants HBM9036, Ophthalmic Solution, twice a day, in the morning and evening HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution	Placebo Ophthalmic Solution n=50 Participants placebo, Ophthalmic Solution, twice a day, in the morning and evening placebo: Ophthalmic Solution	Total n=100 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 11.19 • n=50 Participants	43.9 years STANDARD_DEVIATION 9.15 • n=50 Participants	42.6 years STANDARD_DEVIATION 10.25 • n=100 Participants
Sex: Female, Male Female	25 Participants n=50 Participants	32 Participants n=50 Participants	57 Participants n=100 Participants
Sex: Female, Male Male	25 Participants n=50 Participants	18 Participants n=50 Participants	43 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Outcome measures
Measure	HBM9036 0.25% Ophthalmic Solution n=47 Participants HBM9036, Ophthalmic Solution, twice a day, in the morning and evening HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution	Placebo Ophthalmic Solution n=48 Participants placebo, Ophthalmic Solution, twice a day, in the morning and evening placebo: Ophthalmic Solution
Inferior Corneal Staining (ICS) Score	1.8 units on a scale Standard Deviation 0.44	1.9 units on a scale Standard Deviation 0.46

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	HBM9036 0.25% Ophthalmic Solution n=47 Participants HBM9036, Ophthalmic Solution, twice a day, in the morning and evening HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution	Placebo Ophthalmic Solution n=48 Participants placebo, Ophthalmic Solution, twice a day, in the morning and evening placebo: Ophthalmic Solution
Ocular Discomfort Score	2.94 units on a scale Standard Deviation 0.791	3.10 units on a scale Standard Deviation 0.692

Adverse Events

HBM9036 0.25% Ophthalmic Solution

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Ophthalmic Solution

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Nina Shen

Harbour Biomed

Phone: 18251811067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	HBM9036 0.25% Ophthalmic Solution n=50 participants at risk HBM9036, Ophthalmic Solution, twice a day, in the morning and evening HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution	Placebo Ophthalmic Solution n=50 participants at risk placebo, Ophthalmic Solution, twice a day, in the morning and evening placebo: Ophthalmic Solution
Eye disorders Conjunctival hyperemia	6.0% 3/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Eye disorders Eye pruritus	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Eye disorders Allergic conjunctivitis	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Eye disorders Lacrimation increased	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Eye disorders Ocular pain	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Eye disorders Visual fatigue	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Eye disorders Ocular hyperemia	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Eye disorders Blurred vision	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Infections and infestations Conjunctivitis	6.0% 3/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Skin and subcutaneous tissue disorders Subepidermal hemorrhage	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Infections and infestations Upper respiratory tract infection	10.0% 5/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	10.0% 5/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Infections and infestations Local infection	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Respiratory, thoracic and mediastinal disorders cough	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Respiratory, thoracic and mediastinal disorders Dry throat	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Respiratory, thoracic and mediastinal disorders rhinobyon	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Gastrointestinal disorders Mouth ulcers	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Gastrointestinal disorders toothache	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Gastrointestinal disorders gastritis	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Musculoskeletal and connective tissue disorders backache	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Ear and labyrinth disorders Ear discomfort	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Injury, poisoning and procedural complications Skin trauma	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Injury, poisoning and procedural complications Sprained ligament	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Immune system disorders Seasonal allergies	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
General disorders Chest discomfort	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Skin and subcutaneous tissue disorders Allergic dermatitis	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.
Eye disorders Visual impairment	0.00% 0/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.	2.0% 1/50 • From start of the first study drug administration up to Day 57 or Early termination (ET) 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.