Trial Outcomes & Findings for Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy (NCT NCT00693485)

Last Updated: 2013-04-24

Results Overview

Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Baseline, Month 6

Results posted on

2013-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	400 ug Brimonidine Implant 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	200 ug Brimonidine Implant 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	Sham (no Implant) Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Overall Study STARTED	25	21	24
Overall Study COMPLETED	25	19	24
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	400 ug Brimonidine Implant n=25 Participants 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	200 ug Brimonidine Implant n=21 Participants 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	Sham (no Implant) n=24 Participants Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	Total n=70 Participants Total of all reporting groups
Age, Customized <45 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Customized Between 45 and 65 years	9 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Age, Customized >65 years	16 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants	36 Participants n=4 Participants
Mean Deviation from Normal Visual Field Using the HFA 24-2	-15.5 Decibels (db) FULL_RANGE 5.26 • n=5 Participants	-14.6 Decibels (db) FULL_RANGE 3.67 • n=7 Participants	-17.9 Decibels (db) FULL_RANGE 5.09 • n=5 Participants	-16.0 Decibels (db) n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Safety Population: all patients who received 1 dose of study medication or sham treatment

Outcome measures

Outcome measures
Measure	400 ug Brimonidine Implant n=25 Participants 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	200 ug Brimonidine Implant n=21 Participants 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	Sham (no Implant) n=24 Participants Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Percentage of Patients With a Visual Field Improvement in the Study Eye	12.0 Percentage of Patients	9.5 Percentage of Patients	4.2 Percentage of Patients

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: Safety Population: all patients who received 1 dose of study medication or sham treatment

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.

Outcome measures

Outcome measures
Measure	400 ug Brimonidine Implant n=25 Participants 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	200 ug Brimonidine Implant n=21 Participants 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	Sham (no Implant) n=24 Participants Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Baseline	76.0 Number of Letters Read Correctly Standard Deviation 7.82	80.6 Number of Letters Read Correctly Standard Deviation 6.20	77.3 Number of Letters Read Correctly Standard Deviation 7.71
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Change from Baseline at Month 6	2.8 Number of Letters Read Correctly Standard Deviation 3.68	-2.2 Number of Letters Read Correctly Standard Deviation 18.35	0.3 Number of Letters Read Correctly Standard Deviation 5.18

Adverse Events

400 ug Brimonidine Implant

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

200 ug Brimonidine Implant

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Sham (no Implant)

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	400 ug Brimonidine Implant n=25 participants at risk 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	200 ug Brimonidine Implant n=21 participants at risk 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	Sham (no Implant) n=24 participants at risk Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Cardiac disorders Arteriospasm coronary	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Cataract	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Infections and infestations Cellulitis	4.0% 1/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Injury, poisoning and procedural complications Concussion	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.2% 1/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Nervous system disorders Syncope	4.0% 1/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Vascular disorders Hypertension	4.0% 1/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.

Other adverse events

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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

Measure	400 ug Brimonidine Implant n=25 participants at risk 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	200 ug Brimonidine Implant n=21 participants at risk 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.	Sham (no Implant) n=24 participants at risk Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Eye disorders Conjunctival haemorrhage	24.0% 6/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	12.5% 3/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Investigations Intraocular pressure increased	12.0% 3/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	8.3% 2/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Punctate keratitis	16.0% 4/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.2% 1/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Nervous system disorders Headache	16.0% 4/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Conjunctival Hyperaemia	12.0% 3/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	14.3% 3/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	12.5% 3/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Vascular disorders Hypertension	12.0% 3/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Eye Irritation	12.0% 3/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	8.3% 2/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Eye Pain	12.0% 3/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Blepharitis	8.0% 2/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Psychiatric disorders Anxiety	8.0% 2/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Nervous system disorders Syncope	8.0% 2/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Gastrointestinal disorders Vomiting	8.0% 2/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Infections and infestations Sinusitis	4.0% 1/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	12.5% 3/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Lacrimation Increased	4.0% 1/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	8.3% 2/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Conjunctivitis	4.0% 1/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.2% 1/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Foreign Body Sensation in Eyes	4.0% 1/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Vitreous Detachment	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	8.3% 2/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Cataract	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	4.8% 1/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	12.5% 3/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Eye disorders Retinal Pigmentation	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	9.5% 2/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	8.3% 2/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/25 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	0.00% 0/21 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.	8.3% 2/24 For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.