Trial Outcomes & Findings for Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT01291108)

NCT ID: NCT01291108

Last Updated: 2013-11-06

Results Overview

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 125 participants
• Primary outcome timeframe: Baseline, Day 57
• Results posted on: 2013-11-06

Participant Flow

Pts were randomized at Baseline for the entire study. At Mo 1, pts received either AGN-210669 or bimatoprost. At Mo 2, pts who had received AGN-210669, then received either AGN-210669+bimatoprost or AGN-210669+bimatoprost vehicle and pts who had received bimatoprost, then received either bimatoprost+AGN-210669 or bimatoprost+bimatoprost vehicle.

Participant milestones

Measure	AGN-210669 AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.	AGN-210669 + Bimatoprost AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.	AGN-210669 + Bimatoprost Vehicle AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.	Bimatoprost bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.	Bimatoprost + AGN-210669 bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.	Bimatoprost + Bimatoprost Vehicle bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
Month 1 (Monotherapy) STARTED	65	0	0	60	0	0
Month 1 (Monotherapy) COMPLETED	64	0	0	60	0	0
Month 1 (Monotherapy) NOT COMPLETED	1	0	0	0	0	0
Month 2 (Adjunctive Therapy) STARTED	0	40	24	0	34	26
Month 2 (Adjunctive Therapy) COMPLETED	0	38	24	0	34	25
Month 2 (Adjunctive Therapy) NOT COMPLETED	0	2	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Measure	AGN-210669 Followed by AGN-210669 + Bimatoprost n=44 Participants AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.	AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle n=21 Participants AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.	Bimatoprost Followed by Bimatoprost + AGN-210669 n=40 Participants bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + AGN-210669 applied as 1 drop of each treatment in both eyes every evening for Month 2.	Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle n=20 Participants bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.	Total n=125 Participants Total of all reporting groups
Age, Customized <45 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Age, Customized 45 to 65 years	17 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants	7 Participants n=4 Participants	54 Participants n=21 Participants
Age, Customized >65 years	26 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants	13 Participants n=4 Participants	68 Participants n=21 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants	13 Participants n=4 Participants	82 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants	7 Participants n=4 Participants	43 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Day 57

Population: Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.

Outcome measures

Measure	AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle n=24 Participants AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.	Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle n=26 Participants bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.	Combined Adjunctives n=75 Participants Combined adjunctives refer to the combined groups of 'AGN-210669 0.05% + bimatoprost' and 'bimatoprost + AGN-210669 0.05%'. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
Change From Baseline in Average Eye IOP Change from Baseline at Day 57-Hr 8 (n=24,25,72)	-5.57 Millimeters of Mercury (mmHg) Standard Deviation 3.484	-7.19 Millimeters of Mercury (mmHg) Standard Deviation 3.198	-7.67 Millimeters of Mercury (mmHg) Standard Deviation 2.596
Change From Baseline in Average Eye IOP Baseline - Hour 0	26.16 Millimeters of Mercury (mmHg) Standard Deviation 2.169	25.98 Millimeters of Mercury (mmHg) Standard Deviation 1.962	26.26 Millimeters of Mercury (mmHg) Standard Deviation 2.446
Change From Baseline in Average Eye IOP Baseline - Hour 4	23.91 Millimeters of Mercury (mmHg) Standard Deviation 2.382	23.82 Millimeters of Mercury (mmHg) Standard Deviation 2.301	23.85 Millimeters of Mercury (mmHg) Standard Deviation 2.553
Change From Baseline in Average Eye IOP Baseline - Hour 8	22.49 Millimeters of Mercury (mmHg) Standard Deviation 1.338	22.35 Millimeters of Mercury (mmHg) Standard Deviation 2.024	22.79 Millimeters of Mercury (mmHg) Standard Deviation 2.391
Change From Baseline in Average Eye IOP Baseline - Hour 12	21.48 Millimeters of Mercury (mmHg) Standard Deviation 2.467	22.07 Millimeters of Mercury (mmHg) Standard Deviation 2.596	21.73 Millimeters of Mercury (mmHg) Standard Deviation 2.624
Change From Baseline in Average Eye IOP Change from Baseline at Day 57-Hr 0 (n=24,25,72)	-7.57 Millimeters of Mercury (mmHg) Standard Deviation 2.881	-10.28 Millimeters of Mercury (mmHg) Standard Deviation 3.190	-10.84 Millimeters of Mercury (mmHg) Standard Deviation 3.460
Change From Baseline in Average Eye IOP Change from Baseline at Day 57-Hr 4 (n=24,25,72)	-6.95 Millimeters of Mercury (mmHg) Standard Deviation 2.503	-8.95 Millimeters of Mercury (mmHg) Standard Deviation 3.531	-8.79 Millimeters of Mercury (mmHg) Standard Deviation 3.330
Change From Baseline in Average Eye IOP Change from Baseline at Day 57-Hr 12 (n=16,17,56)	-5.31 Millimeters of Mercury (mmHg) Standard Deviation 2.690	-6.87 Millimeters of Mercury (mmHg) Standard Deviation 2.838	-6.03 Millimeters of Mercury (mmHg) Standard Deviation 2.642

SECONDARY outcome

Timeframe: Baseline, Day 57

Population: Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement

IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.

Outcome measures

Measure	AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle n=24 Participants AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.	Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle n=26 Participants bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.	Combined Adjunctives n=75 Participants Combined adjunctives refer to the combined groups of 'AGN-210669 0.05% + bimatoprost' and 'bimatoprost + AGN-210669 0.05%'. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
Change From Baseline in Worse Eye IOP Baseline - Hour 0	26.56 Millimeters of Mercury (mmHg) Standard Deviation 2.305	26.40 Millimeters of Mercury (mmHg) Standard Deviation 2.069	26.61 Millimeters of Mercury (mmHg) Standard Deviation 2.664
Change From Baseline in Worse Eye IOP Baseline - Hour 4	24.60 Millimeters of Mercury (mmHg) Standard Deviation 2.754	24.25 Millimeters of Mercury (mmHg) Standard Deviation 2.295	24.31 Millimeters of Mercury (mmHg) Standard Deviation 2.685
Change From Baseline in Worse Eye IOP Baseline - Hour 8	23.04 Millimeters of Mercury (mmHg) Standard Deviation 1.687	22.73 Millimeters of Mercury (mmHg) Standard Deviation 2.290	23.17 Millimeters of Mercury (mmHg) Standard Deviation 2.591
Change From Baseline in Worse Eye IOP Baseline - Hour 12	21.72 Millimeters of Mercury (mmHg) Standard Deviation 2.811	22.47 Millimeters of Mercury (mmHg) Standard Deviation 2.598	21.93 Millimeters of Mercury (mmHg) Standard Deviation 2.908
Change From Baseline in Worse Eye IOP Change from Baseline at Day 57-Hr 0 (n=24,25,72)	-7.50 Millimeters of Mercury (mmHg) Standard Deviation 2.989	-10.56 Millimeters of Mercury (mmHg) Standard Deviation 3.435	-10.96 Millimeters of Mercury (mmHg) Standard Deviation 3.705
Change From Baseline in Worse Eye IOP Change from Baseline at Day 57-Hr 4 (n=24,25,72)	-7.38 Millimeters of Mercury (mmHg) Standard Deviation 2.841	-9.16 Millimeters of Mercury (mmHg) Standard Deviation 3.472	-9.01 Millimeters of Mercury (mmHg) Standard Deviation 3.515
Change From Baseline in Worse Eye IOP Change from Baseline at Day 57-Hr 8 (n=24,25,72)	-5.94 Millimeters of Mercury (mmHg) Standard Deviation 3.817	-7.42 Millimeters of Mercury (mmHg) Standard Deviation 3.526	-7.92 Millimeters of Mercury (mmHg) Standard Deviation 3.002
Change From Baseline in Worse Eye IOP Change from Baseline at Day 57-Hr 12 (n=16,17,56)	-5.00 Millimeters of Mercury (mmHg) Standard Deviation 2.696	-7.00 Millimeters of Mercury (mmHg) Standard Deviation 2.969	-5.99 Millimeters of Mercury (mmHg) Standard Deviation 3.076

Adverse Events

AGN-210669

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

AGN-210669 + Bimatoprost

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

AGN-210669 + Bimatoprost Vehicle

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Bimatoprost

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Bimatoprost + AGN-210669

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Bimatoprost + Bimatoprost Vehicle

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	AGN-210669 n=65 participants at risk AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.	AGN-210669 + Bimatoprost n=40 participants at risk AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.	AGN-210669 + Bimatoprost Vehicle n=24 participants at risk AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.	Bimatoprost n=60 participants at risk bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.	Bimatoprost + AGN-210669 n=34 participants at risk bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.	Bimatoprost + Bimatoprost Vehicle n=26 participants at risk bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
Injury, poisoning and procedural complications Uveal Prolapse	0.00% 0/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	3.8% 1/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.

Other adverse events

Measure	AGN-210669 n=65 participants at risk AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.	AGN-210669 + Bimatoprost n=40 participants at risk AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.	AGN-210669 + Bimatoprost Vehicle n=24 participants at risk AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.	Bimatoprost n=60 participants at risk bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.	Bimatoprost + AGN-210669 n=34 participants at risk bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.	Bimatoprost + Bimatoprost Vehicle n=26 participants at risk bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
Eye disorders Foreign Body Sensation in Eyes	3.1% 2/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	12.5% 5/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	10.0% 6/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	8.8% 3/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Eye Pain	0.00% 0/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	22.5% 9/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	4.2% 1/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	23.5% 8/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	7.7% 2/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Eye Pruritus	6.2% 4/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	7.5% 3/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	6.7% 4/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	14.7% 5/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Punctate Keratitis	4.6% 3/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	15.0% 6/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	12.5% 3/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	11.7% 7/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	11.8% 4/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	15.4% 4/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Photophobia	4.6% 3/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	25.0% 10/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	6.7% 4/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	35.3% 12/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	3.8% 1/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Corneal Thickening	29.2% 19/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	25.0% 10/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	16.7% 4/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	3.3% 2/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	44.1% 15/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Conjunctival Hyperaemia	26.2% 17/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	57.5% 23/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	8.3% 2/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	40.0% 24/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	38.2% 13/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	19.2% 5/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Eye Irritation	9.2% 6/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	10.0% 4/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	4.2% 1/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	3.3% 2/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	8.8% 3/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	3.8% 1/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Eye Discharge	7.7% 5/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	7.5% 3/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	5.0% 3/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	2.9% 1/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	3.8% 1/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Vision Blurred	7.7% 5/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	12.5% 5/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	5.0% 3/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	14.7% 5/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Lacrimation Increased	4.6% 3/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	5.0% 2/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	5.9% 2/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Iritis	0.00% 0/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	7.5% 3/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Anterior Chamber Cell	0.00% 0/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	5.0% 2/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	2.9% 1/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	7.7% 2/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Asthenopia	0.00% 0/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	5.0% 2/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
Eye disorders Keratitis	0.00% 0/65 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	5.0% 2/40 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/24 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/60 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.	0.00% 0/26 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER