Trial Outcomes & Findings for Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma (NCT NCT03131167)

Last Updated: 2021-06-08

Results Overview

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

63 participants

Primary outcome timeframe

From start of study drug administration up to follow-up (Day 88)

Results posted on

2021-06-08

Participant Flow

The study was conducted at 4 study centers in the United States between 10 May 2017 (first participant first visit) and 30 May 2018 (last participant last visit).

Totally, 63 participants enrolled, randomized and received treatment in two parts of the study with one cohort for one dose level (Part 1: Cohort A1, A2, A3, with single dose and QD multiple dose, followed by Cohort B1, B2, B3 with BID multiple dose. Part 2: Cohort C1, C2, C3 with TID multiple dose, followed by D1, D2, D3 with QID multiple dose).

Participant milestones

Participant milestones
Measure	Placebo QD Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.1% QD Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.3% QD Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.6% QD Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	Placebo BID Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.1% BID Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.3% BID Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.6% BID Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	Placebo Repeated BID Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	SHP639 0.6% Repeated BID Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	Placebo TID Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.1% TID Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.3% TID Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
Overall Study STARTED	6	5	5	5	6	5	5	5	2	5	4	5	5
Overall Study COMPLETED	6	5	5	5	6	4	5	5	2	5	4	5	5
Overall Study NOT COMPLETED	0	0	0	0	0	1	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo QD Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.1% QD Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.3% QD Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.6% QD Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	Placebo BID Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.1% BID Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.3% BID Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.6% BID Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	Placebo Repeated BID Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	SHP639 0.6% Repeated BID Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	Placebo TID Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.1% TID Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.3% TID Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
Overall Study Other (Unspecified)	0	0	0	0	0	1	0	0	0	0	0	0	0

Baseline Characteristics

Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo QD n=6 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.1% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.3% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.6% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	Placebo BID n=6 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.1% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.3% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.6% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	Placebo Repeated BID n=2 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	SHP639 0.6% Repeated BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	Placebo TID n=4 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.1% TID n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.3% TID n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	Total n=63 Participants Total of all reporting groups
Age, Continuous	64.0 Years STANDARD_DEVIATION 7.77 • n=5 Participants	63.8 Years STANDARD_DEVIATION 7.46 • n=7 Participants	67.6 Years STANDARD_DEVIATION 6.39 • n=5 Participants	59.0 Years STANDARD_DEVIATION 2.74 • n=4 Participants	68.7 Years STANDARD_DEVIATION 8.19 • n=21 Participants	72.8 Years STANDARD_DEVIATION 8.58 • n=10 Participants	69.0 Years STANDARD_DEVIATION 7.31 • n=115 Participants	68.2 Years STANDARD_DEVIATION 6.69 • n=24 Participants	70.0 Years STANDARD_DEVIATION 4.24 • n=42 Participants	74.6 Years STANDARD_DEVIATION 5.18 • n=42 Participants	67.5 Years STANDARD_DEVIATION 18.38 • n=42 Participants	70.8 Years STANDARD_DEVIATION 14.04 • n=42 Participants	69.4 Years STANDARD_DEVIATION 4.93 • n=36 Participants	68.4 Years STANDARD_DEVIATION 8.81 • n=36 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	2 Participants n=115 Participants	4 Participants n=24 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=36 Participants	43 Participants n=36 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=36 Participants	20 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=36 Participants	7 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	5 Participants n=24 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	1 Participants n=36 Participants	56 Participants n=36 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	5 Participants n=115 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	24 Participants n=36 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=36 Participants	37 Participants n=36 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: From start of study drug administration up to follow-up (Day 88)

Population: Safety set consisted of all participants who were randomized and who received at least 1 dose of investigational product.

Outcome measures

Outcome measures
Measure	Placebo QD n=6 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.1% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.3% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.6% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	Placebo BID n=6 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.1% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.3% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen..	SHP639 0.6% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	Placebo Repeated BID n=2 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	SHP639 0.6% Repeated BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	Placebo TID n=4 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.1% TID n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.3% TID n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
Number of Participants With Treatment Emergent Adverse Event (TEAE)	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants	2 Participants	0 Participants	5 Participants	1 Participants	5 Participants	2 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Day 29

Population: Pharmacodynamic (PD) set consisted of all participants in the safety set for whom the primary PD data were evaluable.

IOP was measured using Goldmann applanation tonometry and reported data from baseline at day 29 for both study eye and non study eye.

Outcome measures

Outcome measures
Measure	Placebo QD n=6 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.1% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.3% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.6% QD n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	Placebo BID n=6 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.1% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.3% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen..	SHP639 0.6% BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	Placebo Repeated BID n=2 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	SHP639 0.6% Repeated BID n=5 Participants Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	Placebo TID n=4 Participants Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.1% TID n=5 Participants Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.3% TID n=5 Participants Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
Change From Baseline in Intra Ocular Pressure (IOP) at Day 29 Non-Study Eye	-0.38 millimeter of mercury (mmHg) Standard Deviation 1.430	-1.50 millimeter of mercury (mmHg) Standard Deviation 0.354	1.20 millimeter of mercury (mmHg) Standard Deviation 2.087	0.70 millimeter of mercury (mmHg) Standard Deviation 0.908	0.83 millimeter of mercury (mmHg) Standard Deviation 1.393	0.50 millimeter of mercury (mmHg) Standard Deviation 1.061	-0.20 millimeter of mercury (mmHg) Standard Deviation 0.758	-0.25 millimeter of mercury (mmHg) Standard Deviation 2.610	-1.00 millimeter of mercury (mmHg) Standard Deviation 4.243	-1.80 millimeter of mercury (mmHg) Standard Deviation 2.260	0.00 millimeter of mercury (mmHg) Standard Deviation 3.889	-0.10 millimeter of mercury (mmHg) Standard Deviation 1.421	-3.85 millimeter of mercury (mmHg) Standard Deviation 2.389
Change From Baseline in Intra Ocular Pressure (IOP) at Day 29 Study Eye	0.00 millimeter of mercury (mmHg) Standard Deviation 1.294	-1.20 millimeter of mercury (mmHg) Standard Deviation 1.605	0.45 millimeter of mercury (mmHg) Standard Deviation 1.515	0.40 millimeter of mercury (mmHg) Standard Deviation 1.084	0.38 millimeter of mercury (mmHg) Standard Deviation 1.539	0.44 millimeter of mercury (mmHg) Standard Deviation 1.972	-0.20 millimeter of mercury (mmHg) Standard Deviation 0.837	-0.40 millimeter of mercury (mmHg) Standard Deviation 2.826	-0.13 millimeter of mercury (mmHg) Standard Deviation 2.652	-2.00 millimeter of mercury (mmHg) Standard Deviation 1.490	-1.13 millimeter of mercury (mmHg) Standard Deviation 4.539	0.10 millimeter of mercury (mmHg) Standard Deviation 0.929	-4.65 millimeter of mercury (mmHg) Standard Deviation 3.170

Deaths: 0 deaths

SHP639 0.3% TID

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo QD n=6 participants at risk Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.1% QD n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.3% QD n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	SHP639 0.6% QD n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.	Placebo BID n=6 participants at risk Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.1% BID n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.3% BID n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	SHP639 0.6% BID n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.	Placebo Repeated BID n=2 participants at risk Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	SHP639 0.6% Repeated BID n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.	Placebo TID n=4 participants at risk Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.1% TID n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.	SHP639 0.3% TID n=5 participants at risk Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)
Eye disorders Abnormal sensation in eye	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Conjunctival haemorrhage	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	25.0% 1/4 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Conjunctival hyperaemia	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	40.0% 2/5 • Number of events 2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	50.0% 1/2 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	60.0% 3/5 • Number of events 3 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Eye discharge	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Eye disorder	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Eye pruritus	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Eyelid margin crusting	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Lacrimation increased	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Ocular hyperaemia	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	16.7% 1/6 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Photophobia	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Eye disorders Vision blurred	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	40.0% 2/5 • Number of events 2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
General disorders Instillation site discomfort	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
General disorders Instillation site pain	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	80.0% 4/5 • Number of events 7 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	60.0% 3/5 • Number of events 3 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Infections and infestations Cellulitis	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Infections and infestations Herpes zoster	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	25.0% 1/4 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	25.0% 1/4 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)
Infections and infestations Urinary tract infection	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	25.0% 1/4 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Investigations Vital dye staining cornea present	33.3% 2/6 • Number of events 2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	16.7% 1/6 • Number of events 2 • From start of study drug administration up to follow-up (day 88)	40.0% 2/5 • Number of events 2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	50.0% 1/2 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	100.0% 5/5 • Number of events 7 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/6 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (day 88)	0.00% 0/2 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/4 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)	0.00% 0/5 • From start of study drug administration up to follow-up (day 88)

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER