Trial Outcomes & Findings for 6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT02140060)

NCT ID: NCT02140060

Last Updated: 2015-12-29

Results Overview

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 327 participants
• Primary outcome timeframe: Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM
• Results posted on: 2015-12-29

Participant Flow

Subjects were recruited from 19 study centers located in the US.

Of the 327 enrolled, 61 subjects were discontinued prior to randomization. This reporting group includes all randomized subjects (266).

Participant milestones

Measure	TravA/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravB/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravC/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TRAV Z Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	AZOPT Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks	TRAV Z + AZOPT Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Overall Study STARTED	44	44	44	45	45	44
Overall Study COMPLETED	44	44	44	43	44	43
Overall Study NOT COMPLETED	0	0	0	2	1	1

Reasons for withdrawal

Measure	TravA/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravB/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravC/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TRAV Z Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	AZOPT Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks	TRAV Z + AZOPT Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Overall Study Adverse Event	0	0	0	1	1	1
Overall Study Lack of Efficacy	0	0	0	1	0	0

Baseline Characteristics

6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Measure	TravA/Brinz n=44 Participants Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravB/Brinz n=44 Participants Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravC/Brinz n=44 Participants Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TRAV Z n=45 Participants Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	AZOPT n=45 Participants Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks	TRAV Z + AZOPT n=43 Participants Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	Total n=265 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 10.7 • n=5 Participants	66.2 years STANDARD_DEVIATION 10.4 • n=7 Participants	64.4 years STANDARD_DEVIATION 11.2 • n=5 Participants	64.2 years STANDARD_DEVIATION 10.4 • n=4 Participants	63.1 years STANDARD_DEVIATION 8.4 • n=21 Participants	65.3 years STANDARD_DEVIATION 10.6 • n=10 Participants	64.8 years STANDARD_DEVIATION 10.3 • n=115 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	26 Participants n=7 Participants	30 Participants n=5 Participants	25 Participants n=4 Participants	23 Participants n=21 Participants	19 Participants n=10 Participants	152 Participants n=115 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	14 Participants n=5 Participants	20 Participants n=4 Participants	22 Participants n=21 Participants	24 Participants n=10 Participants	113 Participants n=115 Participants

PRIMARY outcome

Timeframe: Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM

Population: This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit, based upon a last on-therapy carried forward (LOCF) analysis. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm, respectively.

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.

Outcome measures

Measure	TravA/Brinz n=44 Participants Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravB/Brinz n=44 Participants Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravC/Brinz n=44 Participants Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TRAV Z n=45 Participants Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	AZOPT n=45 Participants Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks	TRAV Z + AZOPT n=43 Participants Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Mean IOP at Week 6 8 AM	20.2 mmHg Standard Error 0.52	18.7 mmHg Standard Error 0.48	19.9 mmHg Standard Error 0.58	19.3 mmHg Standard Error 0.48	22.0 mmHg Standard Error 0.45	20.3 mmHg Standard Error 0.72
Mean IOP at Week 6 10 AM	18.9 mmHg Standard Error 0.47	17.2 mmHg Standard Error 0.35	18.2 mmHg Standard Error 0.55	17.4 mmHg Standard Error 0.47	19.7 mmHg Standard Error 0.50	18.2 mmHg Standard Error 0.59
Mean IOP at Week 6 12 PM	18.9 mmHg Standard Error 0.47	17.3 mmHg Standard Error 0.50	17.7 mmHg Standard Error 0.51	17.2 mmHg Standard Error 0.50	19.5 mmHg Standard Error 0.53	18.0 mmHg Standard Error 0.57
Mean IOP at Week 6 4PM	18.5 mmHg Standard Error 0.46	17.5 mmHg Standard Error 0.43	17.3 mmHg Standard Error 0.46	17.6 mmHg Standard Error 0.44	19.1 mmHg Standard Error 0.50	18.0 mmHg Standard Error 0.52
Mean IOP at Week 6 8 PM, n=44, 44, 44, 43, 45, 43	18.4 mmHg Standard Error 0.43	17.5 mmHg Standard Error 0.39	17.2 mmHg Standard Error 0.40	17.3 mmHg Standard Error 0.43	19.3 mmHg Standard Error 0.48	18.1 mmHg Standard Error 0.49

Adverse Events

TravA/Brinz

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

TravB/Brinz

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

TravC/Brinz

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

TRAV Z

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

AZOPT

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

TRAV Z + AZOPT

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Pre-treatment

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	TravA/Brinz n=44 participants at risk Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravB/Brinz n=44 participants at risk Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravC/Brinz n=44 participants at risk Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TRAV Z n=45 participants at risk Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	AZOPT n=45 participants at risk Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks	TRAV Z + AZOPT n=44 participants at risk Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	Pre-treatment n=327 participants at risk All subjects who signed an informed consent to participate in the study
Cardiac disorders Angina unstable	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	2.2% 1/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/327 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.
Cardiac disorders Atrial fibrillation	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.31% 1/327 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.

Other adverse events

Measure	TravA/Brinz n=44 participants at risk Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravB/Brinz n=44 participants at risk Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TravC/Brinz n=44 participants at risk Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks	TRAV Z n=45 participants at risk Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	AZOPT n=45 participants at risk Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks	TRAV Z + AZOPT n=44 participants at risk Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks	Pre-treatment n=327 participants at risk All subjects who signed an informed consent to participate in the study
Eye disorders Ocular hyperaemia	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	18.2% 8/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	13.6% 6/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	15.6% 7/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	18.2% 8/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/327 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.
Eye disorders Conjunctival hyperaemia	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.31% 1/327 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.
Eye disorders Eye irritation	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	4.4% 2/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	2.3% 1/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/327 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.
Eye disorders Eye pain	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	2.2% 1/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	2.3% 1/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/327 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.
Nervous system disorders Dysgeusia	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	2.2% 1/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	8.9% 4/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.	0.00% 0/327 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.

Additional Information

Clinical Project Lead, GCRA, Pharma

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER