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Geographic Atrophy Treatment Evaluation (GATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00890097
Recruitment Status : Terminated (Treatment ineffective)
First Posted : April 29, 2009
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Geographic Atrophy
Age-Related Macular Degeneration
Interventions Drug: AL-8309B Ophthalmic Solution
Drug: AL-8309B Vehicle
Enrollment 772
Recruitment Details Subjects were recruited from 48 study centers located in 14 countries.
Pre-assignment Details This reporting group includes all enrolled subjects (772). A subject was considered enrolled if they met all of the inclusion criteria and none of the exclusion criteria.
Arm/Group Title AL-8309B 1.0% AL-8309B 1.75% Vehicle
Hide Arm/Group Description AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
Period Title: Overall Study
Started 252 259 261
Completed 184 173 184
Not Completed 68 86 77
Reason Not Completed
Adverse Event             21             32             28
Decision Unrelated to an Adverse Event             15             12             17
Withdrew Consent             9             6             9
Lost to Follow-up             5             5             5
Noncompliance             0             4             4
Sponsor Decision             7             11             7
Did not attend final visit             2             3             0
Subject Decision             3             2             6
Randomization Error             2             0             0
Failed inclusion criteria             3             4             0
Transportation             0             2             0
Subject Moved             0             4             0
Protocol Deviation             1             1             1
Arm/Group Title AL-8309B 1.0% AL-8309B 1.75% Vehicle Total
Hide Arm/Group Description AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months Total of all reporting groups
Overall Number of Baseline Participants 252 259 261 772
Hide Baseline Analysis Population Description
This analysis population includes all enrolled subjects (772).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 252 participants 259 participants 261 participants 772 participants
77.9  (8.0) 78.3  (7.7) 78.8  (7.1) 78.3  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 259 participants 261 participants 772 participants
Female
130
  51.6%
162
  62.5%
147
  56.3%
439
  56.9%
Male
122
  48.4%
97
  37.5%
114
  43.7%
333
  43.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 252 participants 259 participants 261 participants 772 participants
United States 111 112 116 339
France 28 27 29 84
Switzerland 21 21 21 63
Germany 18 20 19 57
Australia 16 18 16 50
Israel 13 15 15 43
Italy 12 15 14 41
Austria 13 13 14 40
Belgium 7 6 6 19
United Kingdom 4 3 3 10
Ireland 3 3 3 9
Japan 3 2 3 8
Portugal 2 3 2 7
Canada 1 1 0 2
1.Primary Outcome
Title Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
Hide Description The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.
Time Frame Baseline, up to Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population included all treated subjects. A subject was considered treated if they had a first or last dosing date in the database.
Arm/Group Title AL-8309B 1.0% AL-8309B 1.75% Vehicle
Hide Arm/Group Description:
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
Overall Number of Participants Analyzed 250 258 260
Mean (95% Confidence Interval)
Unit of Measure: square millimeters per year
1.725
(1.595 to 1.855)
1.758
(1.626 to 1.890)
1.707
(1.585 to 1.830)
Time Frame Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
Adverse Event Reporting Description This analysis population includes all treated subjects (768).
 
Arm/Group Title AL-8309B 1.0% AL-8309B 1.75% Vehicle
Hide Arm/Group Description AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
All-Cause Mortality
AL-8309B 1.0% AL-8309B 1.75% Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
AL-8309B 1.0% AL-8309B 1.75% Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   86/250 (34.40%)   96/258 (37.21%)   85/260 (32.69%) 
Blood and lymphatic system disorders       
Anaemia  1  1/250 (0.40%)  3/258 (1.16%)  0/260 (0.00%) 
Iron deficiency anaemia  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Cardiac disorders       
Acute coronary syndrome  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Angina pectoris  1  4/250 (1.60%)  3/258 (1.16%)  1/260 (0.38%) 
Angina unstable  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Arrhythmia  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Arrhythmia supraventricular  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Atrial fibrillation  1  4/250 (1.60%)  3/258 (1.16%)  5/260 (1.92%) 
Atrial flutter  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Atrioventricular block complete  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Atrioventricular block second degree  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Bundle branch block  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Cardiac arrest  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Cardiac disorder  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Cardiac failure  1  2/250 (0.80%)  4/258 (1.55%)  0/260 (0.00%) 
Cardiac failure acute  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Cardiac failure congestive  1  4/250 (1.60%)  3/258 (1.16%)  1/260 (0.38%) 
Coronary artery disease  1  0/250 (0.00%)  2/258 (0.78%)  1/260 (0.38%) 
Coronary artery occlusion  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Myocardial infarction  1  4/250 (1.60%)  0/258 (0.00%)  0/260 (0.00%) 
Myocardial ischaemia  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Sick sinus syndrome  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Sinus arrhythmia  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Tachycardia  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Ventricular tachycardia  1  0/250 (0.00%)  0/258 (0.00%)  2/260 (0.77%) 
Congenital, familial and genetic disorders       
Choledochal cyst  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Endocrine disorders       
Goitre  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Eye disorders       
Cataract  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Macular oedema  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Retinal artery occlusion  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Retinal detachment  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Visual acuity reduced  1  1/250 (0.40%)  1/258 (0.39%)  3/260 (1.15%) 
Gastrointestinal disorders       
Abdominal pain  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Diarrhoea  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Gastritis  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Gastrointestinal haemorrhage  1  1/250 (0.40%)  2/258 (0.78%)  0/260 (0.00%) 
Haematemesis  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Inguinal hernia  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Intestinal obstruction  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Intra-abdominal haematoma  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Intussusception  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Nausea  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Pancreatitis  1  2/250 (0.80%)  0/258 (0.00%)  0/260 (0.00%) 
Pancreatitis acute  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Rectal haemorrhage  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Retroperitoneal haemorrhage  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Small intestinal obstruction  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Umbilical hernia  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Vomiting  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
General disorders       
Asthenia  1  1/250 (0.40%)  0/258 (0.00%)  2/260 (0.77%) 
Chest discomfort  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Chest pain  1  3/250 (1.20%)  1/258 (0.39%)  0/260 (0.00%) 
Death  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
General physical health deterioration  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Impaired healing  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Inflammation  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Non-cardiac chest pain  1  1/250 (0.40%)  0/258 (0.00%)  1/260 (0.38%) 
Pain  1  2/250 (0.80%)  0/258 (0.00%)  0/260 (0.00%) 
Pyrexia  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Biliary tract disorder  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Cholangitis  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Cholecystitis acute  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Cirrhosis alcoholic  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Hepatic cirrhosis  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Immune system disorders       
Anaphylactic shock  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Infections and infestations       
Appendicitis  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Bronchitis  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Cellulitis  1  1/250 (0.40%)  0/258 (0.00%)  1/260 (0.38%) 
Dacryocystitis  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Diverticulitis  1  4/250 (1.60%)  0/258 (0.00%)  0/260 (0.00%) 
Echinococciasis  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Gastroenteritis  1  1/250 (0.40%)  0/258 (0.00%)  2/260 (0.77%) 
Gastroenteritis viral  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Labyrinthitis  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Lobar pneumonia  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Localised infection  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Lower respiratory tract infection  1  0/250 (0.00%)  0/258 (0.00%)  2/260 (0.77%) 
Lung infection  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Pancreatic abscess  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Pneumonia  1  3/250 (1.20%)  9/258 (3.49%)  5/260 (1.92%) 
Pyelonephritis acute  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Sepsis  1  1/250 (0.40%)  3/258 (1.16%)  1/260 (0.38%) 
Sinusitis  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Urinary tract infection  1  0/250 (0.00%)  3/258 (1.16%)  1/260 (0.38%) 
Urosepsis  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Injury, poisoning and procedural complications       
Alcohol poisoning  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Arthropod bite  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Fall  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Injury  1  16/250 (6.40%)  14/258 (5.43%)  15/260 (5.77%) 
Intraocular lens dislocation  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Overdose  1  2/250 (0.80%)  0/258 (0.00%)  0/260 (0.00%) 
Post procedural complication  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Skin laceration  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Subdural haematoma  1  1/250 (0.40%)  0/258 (0.00%)  1/260 (0.38%) 
Investigations       
Arthroscopy  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Catheterisation cardiac  1  2/250 (0.80%)  1/258 (0.39%)  1/260 (0.38%) 
Endoscopy  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Investigation  1  0/250 (0.00%)  0/258 (0.00%)  2/260 (0.77%) 
Oxygen saturation decreased  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Renal function test abnormal  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Hyponatraemia  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/250 (0.40%)  0/258 (0.00%)  2/260 (0.77%) 
Arthritis  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Costochondritis  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Intervertebral disc degeneration  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Intervertebral disc disorder  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Intervertebral disc protrusion  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Kyphosis  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Musculoskeletal chest pain  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Osteoarthritis  1  2/250 (0.80%)  5/258 (1.94%)  2/260 (0.77%) 
Osteoporosis  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Osteoporotic fracture  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Rheumatoid arthritis  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Rotator cuff syndrome  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Spinal column stenosis  1  2/250 (0.80%)  0/258 (0.00%)  0/260 (0.00%) 
Temporomandibular joint syndrome  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma  1  2/250 (0.80%)  0/258 (0.00%)  0/260 (0.00%) 
Bladder cancer  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Breast cancer  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Breast cancer metastatic  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Bronchial carcinoma  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Cardiac valve fibroelastoma  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Colon cancer metastatic  1  1/250 (0.40%)  0/258 (0.00%)  1/260 (0.38%) 
Endometrial cancer  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Hepatic neoplasm malignant non-resectable  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Lung adenocarcinoma stage III  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Lung adenocarcinoma stage IV  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Lung neoplasm malignant  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Malignant melanoma  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Metastases to abdominal cavity  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Metastases to central nervous system  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Metastases to lung  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Multiple myeloma  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Myelodysplastic syndrome  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Neoplasm malignant  1  3/250 (1.20%)  1/258 (0.39%)  0/260 (0.00%) 
Pancreatic carcinoma non-resectable  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Parathyroid tumour benign  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Prostate cancer  1  2/250 (0.80%)  0/258 (0.00%)  0/260 (0.00%) 
Renal cell carcinoma  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Squamous cell carcinoma of skin  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Thyroid adenoma  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Thyroid neoplasm  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Ureteric cancer metastatic  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Nervous system disorders       
Altered state of consciousness  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Carpal tunnel syndrome  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Cerebral artery occlusion  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Cerebral haematoma  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Cerebral haemorrhage  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Cerebrovascular accident  1  3/250 (1.20%)  4/258 (1.55%)  3/260 (1.15%) 
Convulsion  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Dementia  1  1/250 (0.40%)  0/258 (0.00%)  1/260 (0.38%) 
Dizziness  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Dysarthria  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Extrapyramidal disorder  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Grand mal convulsion  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Haemorrhage intracranial  1  0/250 (0.00%)  0/258 (0.00%)  2/260 (0.77%) 
Headache  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Ischaemic stroke  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Loss of consciousness  1  2/250 (0.80%)  0/258 (0.00%)  0/260 (0.00%) 
Nerve compression  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Parkinson's disease  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Sciatica  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Subarachnoid haemorrhage  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Syncope  1  1/250 (0.40%)  2/258 (0.78%)  2/260 (0.77%) 
Syringomyelia  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Transient ischaemic attack  1  4/250 (1.60%)  2/258 (0.78%)  2/260 (0.77%) 
Psychiatric disorders       
Confusional state  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Depression  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Depression suicidal  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Disorientation  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Hallucination, visual  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Major depression  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Mental status changes  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Schizophrenia  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Renal and urinary disorders       
Bladder disorder  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Haematuria  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Hydronephrosis  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Nephrolithiasis  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Pelvi-ureteric obstruction  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Renal failure  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Renal failure acute  1  1/250 (0.40%)  1/258 (0.39%)  1/260 (0.38%) 
Renal failure chronic  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Urinary retention  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/250 (0.40%)  3/258 (1.16%)  1/260 (0.38%) 
Ovarian cyst  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Prostatomegaly  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Vaginal fistula  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/250 (0.00%)  0/258 (0.00%)  3/260 (1.15%) 
Atelectasis  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Chronic obstructive pulmonary disease  1  1/250 (0.40%)  4/258 (1.55%)  1/260 (0.38%) 
Dyspnoea  1  2/250 (0.80%)  1/258 (0.39%)  0/260 (0.00%) 
Dyspnoea exertional  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Hypoxia  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Lung disorder  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Pneumonia aspiration  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Pulmonary congestion  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Pulmonary embolism  1  1/250 (0.40%)  0/258 (0.00%)  3/260 (1.15%) 
Respiratory acidosis  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Respiratory arrest  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Respiratory failure  1  0/250 (0.00%)  0/258 (0.00%)  2/260 (0.77%) 
Sleep apnoea syndrome  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Skin and subcutaneous tissue disorders       
Angioedema  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Surgical and medical procedures       
Angioplasty  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Aortic aneurysm repair  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Aortic valve repair  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Aortic valve replacement  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Appendicectomy  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Bunion operation  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Cardiac pacemaker insertion  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Cardioversion  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Haemorrhoid operation  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Hip arthroplasty  1  0/250 (0.00%)  2/258 (0.78%)  1/260 (0.38%) 
Hip surgery  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Inguinal hernia repair  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Intraocular lens implant  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Intrathecal pump insertion  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Joint arthroplasty  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Keratoplasty  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Knee arthroplasty  1  2/250 (0.80%)  1/258 (0.39%)  0/260 (0.00%) 
Knee operation  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Malignant tumour excision  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Radiotherapy to eye  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Salivary gland operation  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Scoliosis surgery  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Spinal operation  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Vasodilation procedure  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Vascular disorders       
Aortic aneurysm  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Aortic stenosis  1  1/250 (0.40%)  1/258 (0.39%)  0/260 (0.00%) 
Arterial occlusive disease  1  0/250 (0.00%)  1/258 (0.39%)  1/260 (0.38%) 
Circulatory collapse  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Deep vein thrombosis  1  2/250 (0.80%)  0/258 (0.00%)  0/260 (0.00%) 
Haemorrhage  1  0/250 (0.00%)  1/258 (0.39%)  0/260 (0.00%) 
Hypertension  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Hypertensive crisis  1  0/250 (0.00%)  2/258 (0.78%)  0/260 (0.00%) 
Hypotension  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Peripheral arterial occlusive disease  1  1/250 (0.40%)  0/258 (0.00%)  0/260 (0.00%) 
Peripheral vascular disorder  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Temporal arteritis  1  0/250 (0.00%)  0/258 (0.00%)  1/260 (0.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AL-8309B 1.0% AL-8309B 1.75% Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   207/250 (82.80%)   212/258 (82.17%)   207/260 (79.62%) 
Eye disorders       
Blepharitis  1  15/250 (6.00%)  19/258 (7.36%)  7/260 (2.69%) 
Cataract  1  30/250 (12.00%)  23/258 (8.91%)  23/260 (8.85%) 
Choroidal neovascularisation  1  20/250 (8.00%)  20/258 (7.75%)  16/260 (6.15%) 
Eye irritation  1  20/250 (8.00%)  27/258 (10.47%)  9/260 (3.46%) 
Eye pain  1  16/250 (6.40%)  21/258 (8.14%)  11/260 (4.23%) 
Lacrimation increased  1  8/250 (3.20%)  15/258 (5.81%)  3/260 (1.15%) 
Macular degeneration  1  18/250 (7.20%)  20/258 (7.75%)  14/260 (5.38%) 
Retinal haemorrhage  1  14/250 (5.60%)  16/258 (6.20%)  21/260 (8.08%) 
Visual acuity reduced  1  101/250 (40.40%)  107/258 (41.47%)  109/260 (41.92%) 
Gastrointestinal disorders       
Constipation  1  13/250 (5.20%)  4/258 (1.55%)  13/260 (5.00%) 
Gastrooesophageal reflux disease  1  15/250 (6.00%)  11/258 (4.26%)  9/260 (3.46%) 
Nausea  1  15/250 (6.00%)  8/258 (3.10%)  8/260 (3.08%) 
General disorders       
Oedema peripheral  1  14/250 (5.60%)  4/258 (1.55%)  11/260 (4.23%) 
Infections and infestations       
Bronchitis  1  15/250 (6.00%)  21/258 (8.14%)  28/260 (10.77%) 
Influenza  1  7/250 (2.80%)  8/258 (3.10%)  14/260 (5.38%) 
Nasopharyngitis  1  19/250 (7.60%)  19/258 (7.36%)  22/260 (8.46%) 
Urinary tract infection  1  20/250 (8.00%)  28/258 (10.85%)  19/260 (7.31%) 
Injury, poisoning and procedural complications       
Injury  1  34/250 (13.60%)  38/258 (14.73%)  31/260 (11.92%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  6/250 (2.40%)  15/258 (5.81%)  9/260 (3.46%) 
Back pain  1  13/250 (5.20%)  12/258 (4.65%)  17/260 (6.54%) 
Osteoarthritis  1  14/250 (5.60%)  21/258 (8.14%)  12/260 (4.62%) 
Nervous system disorders       
Headache  1  19/250 (7.60%)  15/258 (5.81%)  9/260 (3.46%) 
Psychiatric disorders       
Depression  1  10/250 (4.00%)  9/258 (3.49%)  18/260 (6.92%) 
Vascular disorders       
Hypertension  1  24/250 (9.60%)  30/258 (11.63%)  36/260 (13.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dana Sager, Clinical Manager Group Leader
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00890097    
Other Study ID Numbers: C-08-36
First Submitted: April 27, 2009
First Posted: April 29, 2009
Results First Submitted: June 4, 2014
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014