Trial Outcomes & Findings for Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension (NCT NCT01310777)

Last Updated: 2014-03-06

Results Overview

Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

771 participants

Primary outcome timeframe

Baseline (Day 1), Month 3

Results posted on

2014-03-06

Participant Flow

Subjects were recruited from 63 investigational centers in the Asia-Pacific region, the European Union, Latin America and Caribbean nations, and the United States.

Of the 771 enrolled, 211 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (560).

Participant milestones

Participant milestones
Measure	Brinz/Brim Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brinz Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brim Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Overall Study STARTED	193	192	175
Overall Study COMPLETED	160	178	145
Overall Study NOT COMPLETED	33	14	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Brinz/Brim Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brinz Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brim Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Overall Study Adverse Event	23	1	15
Overall Study Lost to Follow-up	0	4	1
Overall Study Patient's Decision Unrelated to AE	1	1	2
Overall Study Inadequate Control of IOP	5	7	10
Overall Study Other	4	1	2

Baseline Characteristics

Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brinz/Brim n=193 Participants Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brinz n=192 Participants Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brim n=175 Participants Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months	Total n=560 Participants Total of all reporting groups
Age, Customized <65 years	91 participants n=5 Participants	87 participants n=7 Participants	79 participants n=5 Participants	257 participants n=4 Participants
Age, Customized ≥65 years	102 participants n=5 Participants	105 participants n=7 Participants	96 participants n=5 Participants	303 participants n=4 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	102 Participants n=7 Participants	102 Participants n=5 Participants	310 Participants n=4 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	90 Participants n=7 Participants	73 Participants n=5 Participants	250 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Month 3

Population: The intent-to-treat (ITT) analysis set included all subjects who received study drug and completed at least 1 scheduled on-therapy study visit.

Outcome measures

Outcome measures
Measure	Brinz/Brim n=176 Participants Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brinz n=182 Participants Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brim n=161 Participants Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Mean Diurnal IOP Change From Baseline at Month 3	-7.9 millimeters of mercury (mmHg) Standard Error 0.22	-6.5 millimeters of mercury (mmHg) Standard Error 0.23	-6.4 millimeters of mercury (mmHg) Standard Error 0.24

Adverse Events

Brinz/Brim

Serious events: 5 serious events

Other events: 44 other events

Deaths: 0 deaths

Brinz

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Brim

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brinz/Brim n=193 participants at risk Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brinz n=192 participants at risk Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brim n=175 participants at risk Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.52% 1/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Infections and infestations Cellulitis	0.52% 1/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.52% 1/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Hepatobiliary disorders Cholelithiasis	0.52% 1/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.52% 1/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.52% 1/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.52% 1/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Renal and urinary disorders Calculus urethral	0.00% 0/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.52% 1/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Hepatobiliary disorders Cholecystitis	0.00% 0/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.52% 1/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Nervous system disorders Carotid artery occlusion	0.00% 0/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.57% 1/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Injury, poisoning and procedural complications Concussion	0.00% 0/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.57% 1/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Infections and infestations Cystitis	0.00% 0/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.57% 1/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Nervous system disorders Headache	0.00% 0/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.57% 1/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Eye disorders Macular degeneration	0.00% 0/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.57% 1/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.

Other adverse events

Other adverse events
Measure	Brinz/Brim n=193 participants at risk Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brinz n=192 participants at risk Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months	Brim n=175 participants at risk Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Eye disorders Ocular hyperaemia	5.7% 11/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	1.6% 3/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	5.1% 9/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Eye disorders Conjunctivitis	5.7% 11/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	1.0% 2/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	1.1% 2/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Eye disorders Vision Blurred	5.7% 11/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.52% 1/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	1.7% 3/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Eye disorders Eye Pain	5.7% 11/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	1.6% 3/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	0.00% 0/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Gastrointestinal disorders Dry Mouth	3.6% 7/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	1.0% 2/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	5.1% 9/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Nervous system disorders Dysgeusia	5.7% 11/193 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	2.1% 4/192 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.	1.1% 2/175 • Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication. This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.

Additional Information

Matt Walker, PhD, Clinical Project Lead

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

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