Trial Outcomes & Findings for H-1337 Ophthalmic Solution Phase 1/2 (NCT NCT03452033)

NCT ID: NCT03452033

Last Updated: 2022-07-12

Results Overview

Mean change in IOP from baseline on Day 28 (Time 0 + 4h)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 87 participants
• Primary outcome timeframe: Baseline and 28 days
• Results posted on: 2022-07-12

Participant Flow

A total of 87 subjects were enrolled and randomized across 6 investigational sites in the United States.

During the screening phase (Screening and Baseline Visits), subjects washed out any current ocular hypotensive therapy according to the below schedule: Muscarinic agonists (eg, pilocarpine) and oral or topical carbonic anhydrase inhibitor (CAIs): ≥5 days Alpha adrenoceptor agonists: ≥5 weeks Beta-adrenoceptor antagonists: ≥6 weeks Prostaglandin analogues and combination drugs (use longest wash-out period of individual components): ≥6 weeks

Unit of analysis: study eyes

Participant milestones

Measure	H-1337 0.06% H-1337 Ophthalmic Solution Concentration 0.06%	H-1337 0.2% H-1337 Ophthalmic Solution Concentration 0.2%	H-1337 0.6% H-1337 Ophthalmic Solution Concentration 0.6%	Vehicle Vehicle (contains all components of the active formulation with the exception of H-1337)
Overall Study STARTED	21 21	22 22	22 22	22 22
Overall Study COMPLETED	21 21	22 22	22 22	22 22
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

H-1337 Ophthalmic Solution Phase 1/2

Baseline characteristics by cohort

Measure	H-1337 0.06% n=21 Participants H-1337 Ophthalmic Solution Concentration 0.06%	H-1337 0.2% n=22 Participants H-1337 Ophthalmic Solution Concentration 0.2%	H-1337 0.6% n=22 Participants H-1337 Ophthalmic Solution Concentration 0.6%	Vehicle n=22 Participants Vehicle (contains all components of the active formulation with the exception of H-1337)	Total n=87 Participants Total of all reporting groups
Age, Continuous	61.1 years STANDARD_DEVIATION 13.58 • n=5 Participants	64.1 years STANDARD_DEVIATION 10.02 • n=7 Participants	67.4 years STANDARD_DEVIATION 11.72 • n=5 Participants	65.0 years STANDARD_DEVIATION 14.44 • n=4 Participants	64.5 years STANDARD_DEVIATION 12.53 • n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	52 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	35 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	21 Participants n=4 Participants	78 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	18 Participants n=4 Participants	77 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	21 participants n=5 Participants	22 participants n=7 Participants	22 participants n=5 Participants	22 participants n=4 Participants	87 participants n=21 Participants
Intraocular pressure ≤26 mmHg	14 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	58 Participants n=21 Participants
Intraocular pressure >26 mmHg	7 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	29 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 28 days

Population: mmHg in the study eye

Mean change in IOP from baseline on Day 28 (Time 0 + 4h)

Outcome measures

Measure	H-1337 0.06% n=21 study eyes H-1337 Ophthalmic Solution 0.06%	H-1337 0.2% n=22 study eyes H-1337 Ophthalmic Solution 0.2%	H-1337 0.6% n=22 study eyes H-1337 Ophthalmic Solution 0.6%	Vehicle n=22 study eyes Vehicle (contains all components of the active formulation with the exception of H-1337)
Intraocular Pressure (IOP)	-4.45 mm Hg Standard Deviation 3.801	-5.16 mm Hg Standard Deviation 3.114	-4.93 mm Hg Standard Deviation 3.110	-0.39 mm Hg Standard Deviation 2.355

SECONDARY outcome

Timeframe: 28 days

Number of participants with treatment-emergent adverse events

Outcome measures

Measure	H-1337 0.06% n=21 Participants H-1337 Ophthalmic Solution 0.06%	H-1337 0.2% n=22 Participants H-1337 Ophthalmic Solution 0.2%	H-1337 0.6% n=22 Participants H-1337 Ophthalmic Solution 0.6%	Vehicle n=22 Participants Vehicle (contains all components of the active formulation with the exception of H-1337)
Number of Participants With Adverse Events	9 Participants	9 Participants	14 Participants	4 Participants

Adverse Events

H-1337 0.06%

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

H-1337 0.2%

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

H-1337 0.6%

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	H-1337 0.06% n=21 participants at risk H-1337 Ophthalmic Solution Concentration 0.06%	H-1337 0.2% n=22 participants at risk H-1337 Ophthalmic Solution Concentration 0.2%	H-1337 0.6% n=22 participants at risk H-1337 Ophthalmic Solution Concentration 0.6%	Vehicle n=22 participants at risk Vehicle (contains all components of the active formulation with the exception of H-1337)
Eye disorders Eye disorders	23.8% 5/21 • Number of events 21 • 28 days	13.6% 3/22 • Number of events 22 • 28 days	22.7% 5/22 • Number of events 22 • 28 days	9.1% 2/22 • Number of events 22 • 28 days
General disorders General disorders and administration site conditiions	28.6% 6/21 • Number of events 21 • 28 days	36.4% 8/22 • Number of events 22 • 28 days	59.1% 13/22 • Number of events 22 • 28 days	9.1% 2/22 • Number of events 22 • 28 days

Additional Information

Shigenobu Nakazora

D. Western Therapeutics Institute

Phone: +81-52-218-8785

Email: shinakazora@dwti.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place