Trial Outcomes & Findings for POLAT-001 Compared to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Open-angle Glaucoma (NCT NCT02466399)

NCT ID: NCT02466399

Last Updated: 2020-11-16

Results Overview

The mean change from baseline intraocular pressure at 3 months (0800 hrs)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-11-16

Participant Flow

Participant milestones

Measure	POLAT-001 Latanoprost liposome ophthalmic injection POLAT-001: Subconjunctival injection	Latanoprost Ophthalmic Solution latanoprost ophthalmic solution 0.005% Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening
Overall Study STARTED	53	27
Overall Study COMPLETED	51	27
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	POLAT-001 Latanoprost liposome ophthalmic injection POLAT-001: Subconjunctival injection	Latanoprost Ophthalmic Solution latanoprost ophthalmic solution 0.005% Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening
Overall Study Adverse Event	1	0
Overall Study Early exit due to family emergency	1	0

Baseline Characteristics

POLAT-001 Compared to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Open-angle Glaucoma

Baseline characteristics by cohort

Measure	POLAT-001 n=53 Participants Latanoprost liposome ophthalmic injection POLAT-001: Subconjunctival injection	Latanoprost Ophthalmic Solution n=27 Participants latanoprost ophthalmic solution 0.005% Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening	Total n=80 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 9.39 • n=5 Participants	63.1 years STANDARD_DEVIATION 11.69 • n=7 Participants	63.9 years STANDARD_DEVIATION 10.17 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	12 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	20 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	22 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Per protocol

The mean change from baseline intraocular pressure at 3 months (0800 hrs)

Outcome measures

Measure	POLAT-001 n=45 Participants Latanoprost liposome ophthalmic injection POLAT-001: Subconjunctival injection	Latanoprost Ophthalmic Solution n=27 Participants latanoprost ophthalmic solution 0.005% Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening
Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months	-2.3 mmHg Standard Deviation 4.6	-6.4 mmHg Standard Deviation 2.9

Adverse Events

POLAT-001

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Latanoprost Ophthalmic Solution

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	POLAT-001 n=53 participants at risk Latanoprost liposome ophthalmic injection POLAT-001: Subconjunctival injection	Latanoprost Ophthalmic Solution n=27 participants at risk latanoprost ophthalmic solution 0.005% Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening
Renal and urinary disorders bone and bladder cancer	1.9% 1/53 • Number of events 1 • 3 months	0.00% 0/27 • 3 months

Other adverse events

Measure	POLAT-001 n=53 participants at risk Latanoprost liposome ophthalmic injection POLAT-001: Subconjunctival injection	Latanoprost Ophthalmic Solution n=27 participants at risk latanoprost ophthalmic solution 0.005% Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening
Eye disorders Conjunctival haemorrhage	26.4% 14/53 • Number of events 27 • 3 months	0.00% 0/27 • 3 months
Eye disorders Foreign body sensation in eyes	17.0% 9/53 • Number of events 9 • 3 months	0.00% 0/27 • 3 months
Eye disorders Conjunctival hyperaemia	13.2% 7/53 • Number of events 7 • 3 months	0.00% 0/27 • 3 months
Eye disorders Instillation site erythema	5.7% 3/53 • Number of events 3 • 3 months	0.00% 0/27 • 3 months
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	5.7% 3/53 • Number of events 3 • 3 months	3.7% 1/27 • Number of events 1 • 3 months

Additional Information

Chief Operating Officer

Peregrine Ophthalmic Pte Ltd

Phone: 65 97914382

Email: jchua@peregrineop.com

Results disclosure agreements

• Principal investigator is a sponsor employee If multi-center study publication not published within two (2) years after the completion of the Study at all sites, Investigator may publish the results of the Study obtained by Investigator with 60 days notice to Sponsor
• Publication restrictions are in place

Restriction type: OTHER