Trial Outcomes & Findings for A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study (NCT NCT03691662)

NCT ID: NCT03691662

Last Updated: 2023-08-09

Results Overview

Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 417 participants
• Primary outcome timeframe: 08:00, 10:00 and 16:00 at Week 1
• Results posted on: 2023-08-09

Participant Flow

Participant milestones

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Overall Study STARTED	208	209
Overall Study Safety and Full Analysis Set (FAS) Participants	204	205
Overall Study COMPLETED	187	196
Overall Study NOT COMPLETED	21	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

Baseline characteristics by cohort

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=204 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=205 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)	Total n=409 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=5 Participants	87 Participants n=7 Participants	176 Participants n=5 Participants
Age, Categorical >=65 years	115 Participants n=5 Participants	118 Participants n=7 Participants	233 Participants n=5 Participants
Age, Continuous	64.0 years STANDARD_DEVIATION 11.43 • n=5 Participants	64.8 years STANDARD_DEVIATION 11.56 • n=7 Participants	64.4 years STANDARD_DEVIATION 11.49 • n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants	109 Participants n=7 Participants	230 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	96 Participants n=7 Participants	179 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	72 Participants n=5 Participants	54 Participants n=7 Participants	126 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	122 Participants n=5 Participants	140 Participants n=7 Participants	262 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	204 participants n=5 Participants	205 participants n=7 Participants	409 participants n=5 Participants

PRIMARY outcome

Timeframe: 08:00, 10:00 and 16:00 at Week 1

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1.

Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.

Outcome measures

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=204 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=205 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Intraocular Pressure (IOP) at Week 1 8:00	19.4 mmHg Standard Error 0.23	19.7 mmHg Standard Error 0.23
Intraocular Pressure (IOP) at Week 1 10:00	18.5 mmHg Standard Error 0.22	18.9 mmHg Standard Error 0.22
Intraocular Pressure (IOP) at Week 1 16:00	17.9 mmHg Standard Error 0.23	18.6 mmHg Standard Error 0.22

PRIMARY outcome

Timeframe: 08:00, 10:00 and 16:00 at Week 6

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 6.

Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.

Outcome measures

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=204 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=205 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Intraocular Pressure (IOP) at Week 6 8:00	20.4 mmHg Standard Error 0.22	19.5 mmHg Standard Error 0.21
Intraocular Pressure (IOP) at Week 6 10:00	19.5 mmHg Standard Error 0.20	18.8 mmHg Standard Error 0.20
Intraocular Pressure (IOP) at Week 6 16:00	19.2 mmHg Standard Error 0.21	18.8 mmHg Standard Error 0.21

PRIMARY outcome

Timeframe: 08:00, 10:00 and 16:00 at Month 3

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3.

Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.

Outcome measures

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=204 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=205 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Intraocular Pressure (IOP) at Month 3 8:00	20.0 mmHg Standard Error 0.22	19.6 mmHg Standard Error 0.22
Intraocular Pressure (IOP) at Month 3 10:00	19.4 mmHg Standard Error 0.23	18.9 mmHg Standard Error 0.22
Intraocular Pressure (IOP) at Month 3 16:00	19.1 mmHg Standard Error 0.23	19.0 mmHg Standard Error 0.22

SECONDARY outcome

Timeframe: Month 3

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3.

To determine if the mean diurnal IOP reduction with DE-117 ophthalmic solution 0.002% is superior to that of Timolol Maleate ophthalmic solution 0.5% at Month 3 in subjects with OAG or OHT. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at Month 3.

Outcome measures

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=188 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=197 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)	19.5 mmHg Standard Error 0.19	19.2 mmHg Standard Error 0.19

SECONDARY outcome

Timeframe: 08:00, 10:00 and 16:00 at week 1

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1.

Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)

Outcome measures

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=112 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=128 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 8:00	18.3 mmHg Standard Error 0.28	19.1 mmHg Standard Error 0.26
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 10:00	17.5 mmHg Standard Error 0.27	18.2 mmHg Standard Error 0.25
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 16:00	17.0 mmHg Standard Error 0.27	18.0 mmHg Standard Error 0.25

SECONDARY outcome

Timeframe: 08:00, 10:00 and 16:00 at week 6

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 6.

Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)

Outcome measures

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=112 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=128 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 8:00	19.4 mmHg Standard Error 0.28	18.9 mmHg Standard Error 0.26
Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 10:00	18.6 mmHg Standard Error 0.25	18.2 mmHg Standard Error 0.24
Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 16:00	18.4 mmHg Standard Error 0.26	18.0 mmHg Standard Error 0.24

SECONDARY outcome

Timeframe: 08:00, 10:00 and 16:00 at month 3

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3.

Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)

Outcome measures

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=112 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=128 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 8:00	18.9 mmHg Standard Error 0.29	18.8 mmHg Standard Error 0.27
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 10:00	18.3 mmHg Standard Error 0.28	18.0 mmHg Standard Error 0.26
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 16:00	18.1 mmHg Standard Error 0.28	18.0 mmHg Standard Error 0.26

SECONDARY outcome

Timeframe: week 1

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1.

The third key secondary endpoint, mean diurnal IOP at Week 1, the hypothesis of superiority of DE-117 to timolol was tested. Analysis using MMRM on Observed Cases.

Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.

Outcome measures

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n=198 Participants DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00).	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n=200 Participants Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 \& 08:00)
Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)	18.6 mmHg Standard Error 0.20	19.1 mmHg Standard Error 0.20

Adverse Events

DE-117 Ophthalmic Solution

Serious events: 7 serious events

Other events: 68 other events

Deaths: 1 deaths

Timolol Maleate Ophthalmic Solution 0.5%

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	DE-117 Ophthalmic Solution n=204 participants at risk Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months	Timolol Maleate Ophthalmic Solution 0.5% n=205 participants at risk Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
Eye disorders Cystoid macular oedema	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Cardiac disorders Myocardial infarction	0.49% 1/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.49% 1/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.49% 1/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Nervous system disorders Generalised tonic-clonic seizure	0.49% 1/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.49% 1/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Vascular disorders Hypertension	0.49% 1/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.

Other adverse events

Measure	DE-117 Ophthalmic Solution n=204 participants at risk Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months	Timolol Maleate Ophthalmic Solution 0.5% n=205 participants at risk Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
Eye disorders Conjunctival hyperaemia	7.8% 16/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	3.4% 7/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Photophobia	5.9% 12/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.49% 1/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Vision blurred	2.9% 6/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Ocular hyperaemia	2.0% 4/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Anterior chamber cell	1.5% 3/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Cystoid macular oedema	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Erythema of eyelid	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Eye pain	2.0% 4/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Growth of eyelashes	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	2.4% 5/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Iritis	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Ocular discomfort	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Dry eye	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Eye pruritus	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Lacrimation increased	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Punctate keratitis	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.49% 1/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Visual impairment	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	1.5% 3/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
General disorders Instillation site pain	5.4% 11/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	6.3% 13/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Investigations Intraocular pressure increased	2.5% 5/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Investigations Vital dye staining cornea present	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.49% 1/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Vitreous detachment	1.5% 3/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.49% 1/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Conjunctival haemorrhage	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	1.5% 3/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Eye disorders Foreign body sensation in eyes	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Infections and infestations Upper respiratory tract infection	2.5% 5/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	1.5% 3/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Infections and infestations Bronchitis	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	1.5% 3/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Infections and infestations Influenza	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Infections and infestations Pneumonia	0.49% 1/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Infections and infestations Sinusitis	0.00% 0/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	1.5% 3/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Investigations Blood pressure increased	0.98% 2/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Nervous system disorders Headache	1.5% 3/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.00% 0/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Vascular disorders Hypertension	0.49% 1/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/204 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.	0.98% 2/205 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3. The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population. Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.

Additional Information

Director of R&D Quality Management

Santen Inc

Phone: 15106851794

Email: evelyn.chikere@santen.com

Results disclosure agreements

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