Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis (NCT NCT03320434)

NCT ID: NCT03320434

Last Updated: 2022-10-17

Results Overview

Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

Results posted on

2022-10-17

Participant Flow

Subjects were recruited from one site in the US.

One hundred and twenty participants enrolled and 97 subjects completed the study. Participant flow and baseline characteristics are presented for 120 subjects that met all inclusion, none of the exclusion criteria, and were randomized to receive one of five treatments based on the randomization list.

Participant milestones

Participant milestones
Measure	PRT-2761 0.5% PRT-2761 0.5%: Six drops in each eye over a 17 day period.	PRT-2761 1% PRT-2761 1%: Six drops in each eye over a 17 day period.	Patanol Patanol: Six drops in each eye over a 17 day period.	PRT-2761 0% PRT-2761 0%: Six drops in each eye over a 17 day period.
Overall Study STARTED	32	29	30	29
Overall Study COMPLETED	25	23	28	23
Overall Study NOT COMPLETED	7	6	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRT-2761 0.5% n=32 Participants PRT-2761 0.5%: Six drops in each eye over a 17 day period.	PRT-2761 1% n=29 Participants PRT-2761 1%: Six drops in each eye over a 17 day period.	Patanol n=30 Participants Patanol: Six drops in each eye over a 17 day period.	PRT-2761 0% n=29 Participants PRT-2761 0%: Six drops in each eye over a 17 day period.	Total n=120 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	4 Participants n=7 Participants	9 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=99 Participants	27 Participants n=107 Participants	30 Participants n=206 Participants	27 Participants n=7 Participants	114 Participants n=31 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants	6 Participants n=31 Participants
Age, Continuous	52 years STANDARD_DEVIATION 14.49 • n=99 Participants	49 years STANDARD_DEVIATION 12.98 • n=107 Participants	46 years STANDARD_DEVIATION 10.81 • n=206 Participants	52 years STANDARD_DEVIATION 9.21 • n=7 Participants	50 years STANDARD_DEVIATION 12.98 • n=31 Participants
Sex: Female, Male Female	24 Participants n=99 Participants	12 Participants n=107 Participants	16 Participants n=206 Participants	15 Participants n=7 Participants	67 Participants n=31 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	17 Participants n=107 Participants	14 Participants n=206 Participants	14 Participants n=7 Participants	53 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	9 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	20 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=99 Participants	20 Participants n=107 Participants	27 Participants n=206 Participants	24 Participants n=7 Participants	100 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) White	29 Participants n=99 Participants	27 Participants n=107 Participants	27 Participants n=206 Participants	23 Participants n=7 Participants	106 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	2 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Region of Enrollment United States	32 participants n=99 Participants	29 participants n=107 Participants	30 participants n=206 Participants	29 participants n=7 Participants	120 participants n=31 Participants
Iris Color Black	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants	2 Participants n=31 Participants
Iris Color Blue	10 Participants n=99 Participants	12 Participants n=107 Participants	8 Participants n=206 Participants	6 Participants n=7 Participants	36 Participants n=31 Participants
Iris Color Brown	13 Participants n=99 Participants	12 Participants n=107 Participants	15 Participants n=206 Participants	17 Participants n=7 Participants	57 Participants n=31 Participants
Iris Color Hazel	4 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants	1 Participants n=7 Participants	14 Participants n=31 Participants
Iris Color Green	5 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants	11 Participants n=31 Participants
Average Post-CAC Itching Score at Baseline ≤ 2.5	7 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants	5 Participants n=7 Participants	23 Participants n=31 Participants
Average Post-CAC Itching Score at Baseline > 2.5	25 Participants n=99 Participants	24 Participants n=107 Participants	24 Participants n=206 Participants	24 Participants n=7 Participants	97 Participants n=31 Participants
Allergen Type Seasonal	22 Participants n=99 Participants	21 Participants n=107 Participants	20 Participants n=206 Participants	20 Participants n=7 Participants	83 Participants n=31 Participants
Allergen Type Perennial	10 Participants n=99 Participants	8 Participants n=107 Participants	10 Participants n=206 Participants	9 Participants n=7 Participants	37 Participants n=31 Participants
Confocal Participation Yes	11 Participants n=99 Participants	8 Participants n=107 Participants	10 Participants n=206 Participants	8 Participants n=7 Participants	37 Participants n=31 Participants
Confocal Participation No	21 Participants n=99 Participants	21 Participants n=107 Participants	20 Participants n=206 Participants	21 Participants n=7 Participants	83 Participants n=31 Participants

PRIMARY outcome

Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1

Population: All Randomized Participants Population - All participants who received study treatment. Note: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits.

Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.

Outcome measures

Outcome measures
Measure	PRT-2761 0.5% n=32 Participants PRT-2761 0.5%: Six drops in each eye over a 17 day period.	PRT-2761 1% n=29 Participants PRT-2761 1%: Six drops in each eye over a 17 day period.	Patanol n=30 Participants Patanol: Six drops in each eye over a 17 day period.	PRT-2761 0% n=29 Participants PRT-2761 0%: Six drops in each eye over a 17 day period.
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 5 minutes post-CAC	2.573 units on a scale Standard Deviation 0.9246	2.500 units on a scale Standard Deviation 0.7792	1.217 units on a scale Standard Deviation 0.8826	2.647 units on a scale Standard Deviation 0.8170
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 7 minutes post-CAC	2.677 units on a scale Standard Deviation 0.8879	2.509 units on a scale Standard Deviation 0.8114	1.358 units on a scale Standard Deviation 0.8627	2.629 units on a scale Standard Deviation 0.7459
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 10 minutes post-CAC	2.250 units on a scale Standard Deviation 1.0878	2.293 units on a scale Standard Deviation 1.0135	1.258 units on a scale Standard Deviation 0.9727	2.190 units on a scale Standard Deviation 0.8754

PRIMARY outcome

Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15

Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.

Outcome measures

Outcome measures
Measure	PRT-2761 0.5% n=32 Participants PRT-2761 0.5%: Six drops in each eye over a 17 day period.	PRT-2761 1% n=29 Participants PRT-2761 1%: Six drops in each eye over a 17 day period.	Patanol n=30 Participants Patanol: Six drops in each eye over a 17 day period.	PRT-2761 0% n=29 Participants PRT-2761 0%: Six drops in each eye over a 17 day period.
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 5 minutes post-CAC	2.431 units on a scale Standard Deviation 1.1415	2.611 units on a scale Standard Deviation 0.7731	0.775 units on a scale Standard Deviation 0.7172	2.527 units on a scale Standard Deviation 0.9288
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 7 minutes post-CAC	2.362 units on a scale Standard Deviation 1.0724	2.602 units on a scale Standard Deviation 0.7883	0.808 units on a scale Standard Deviation 0.7505	2.366 units on a scale Standard Deviation 0.9317
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 10 minutes post-CAC	1.922 units on a scale Standard Deviation 1.1242	2.204 units on a scale Standard Deviation 1.0630	0.833 units on a scale Standard Deviation 0.8077	1.929 units on a scale Standard Deviation 0.9425

PRIMARY outcome

Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.

Outcome measures

Outcome measures
Measure	PRT-2761 0.5% n=32 Participants PRT-2761 0.5%: Six drops in each eye over a 17 day period.	PRT-2761 1% n=29 Participants PRT-2761 1%: Six drops in each eye over a 17 day period.	Patanol n=30 Participants Patanol: Six drops in each eye over a 17 day period.	PRT-2761 0% n=29 Participants PRT-2761 0%: Six drops in each eye over a 17 day period.
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 7 minutes post-CAC	1.282 units on a scale Standard Deviation 0.6479	1.491 units on a scale Standard Deviation 0.5919	1.592 units on a scale Standard Deviation 0.7236	1.957 units on a scale Standard Deviation 0.4913
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 15 minutes post-CAC	1.411 units on a scale Standard Deviation 0.6142	1.526 units on a scale Standard Deviation 0.5989	1.833 units on a scale Standard Deviation 0.7350	2.181 units on a scale Standard Deviation 0.3774
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 20 minutes post-CAC	1.371 units on a scale Standard Deviation 0.5841	1.603 units on a scale Standard Deviation 0.6251	1.917 units on a scale Standard Deviation 0.6833	2.164 units on a scale Standard Deviation 0.4496

PRIMARY outcome

Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

Population: All Randomized Participants Population - All participants who received study treatment. Note: Pred forte subjects receive Patanol up to and including Visit 5a.

Outcome measures

Outcome measures
Measure	PRT-2761 0.5% n=32 Participants PRT-2761 0.5%: Six drops in each eye over a 17 day period.	PRT-2761 1% n=29 Participants PRT-2761 1%: Six drops in each eye over a 17 day period.	Patanol n=30 Participants Patanol: Six drops in each eye over a 17 day period.	PRT-2761 0% n=29 Participants PRT-2761 0%: Six drops in each eye over a 17 day period.
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 7 minutes post-CAC	1.723 units on a scale Standard Deviation 0.5787	2.056 units on a scale Standard Deviation 0.4458	1.242 units on a scale Standard Deviation 0.7296	1.973 units on a scale Standard Deviation 0.4731
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 15 minutes post-CAC	1.920 units on a scale Standard Deviation 0.6703	2.176 units on a scale Standard Deviation 0.4894	1.617 units on a scale Standard Deviation 0.7478	1.991 units on a scale Standard Deviation 0.5464
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 20 minutes post-CAC	1.857 units on a scale Standard Deviation 0.6289	2.222 units on a scale Standard Deviation 0.6699	1.592 units on a scale Standard Deviation 0.7266	2.036 units on a scale Standard Deviation 0.6372

Adverse Events

PRT-2761 0.5%

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PRT-2761 1%

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Patanol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

PRT-2761 0%

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Caitlin Pearson

Ora, Inc

Phone: 978-685-8900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	PRT-2761 0.5% n=32 participants at risk PRT-2761 0.5%: Six drops in each eye over a 17 day period.	PRT-2761 1% n=29 participants at risk PRT-2761 1%: Six drops in each eye over a 17 day period.	Patanol n=30 participants at risk Patanol: Six drops in each eye over a 17 day period.	PRT-2761 0% n=29 participants at risk PRT-2761 0%: Six drops in each eye over a 17 day period.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Visual Acuity Reduced	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	10.3% 3/29 • Number of events 3 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Conjunctival Haemorrhage	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Conjunctival Pigmentation	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Corneal Opacity	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Dry Eye	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Eye Discharge	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Eyelid Oedema	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Meibomian Gland Dysfunction	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Punctate Keratitis	3.1% 1/32 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders Retinal Haemorrhage	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Skin and subcutaneous tissue disorders Skin Discolouration	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Cardiac disorders Palpitations	3.1% 1/32 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Gastrointestinal disorders Abdominal Discomfort	3.1% 1/32 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Gastrointestinal disorders Diarrhoea	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Gastrointestinal disorders Irritable Bowel Syndrome	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.3% 1/30 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Infections and infestations Nasopharyngitis	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 1/32 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Nervous system disorders Dysgeusia	0.00% 0/32 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	3.4% 1/29 • Number of events 1 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/30 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	0.00% 0/29 • Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.