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Trial record 1 of 1 for:    NCT01849692
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ESBA1008 Microvolume Study

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ClinicalTrials.gov Identifier: NCT01849692
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : February 25, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Exudative Age-Related Macular Degeneration
Interventions Drug: ESBA1008 solution
Drug: Ranibizumab
Enrollment 107
Recruitment Details Subjects were recruited from 12 investigational centers located in the US, Australia, and the Dominican Republic.
Pre-assignment Details Of the 107 enrolled, 55 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized participants (52).
Arm/Group Title Cohort 1 - ESBA Cohort 1 - Ranibizumab Cohort 2 - ESBA Cohort 2 - Ranibizumab Cohort 3 - ESBA Cohort 3 - Ranibizumab Cohort 4 - ESBA Cohort 4 - Ranibizumab
Hide Arm/Group Description ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg) Ranibizumab 0.5 mg injection, Day 0 and Day 28 ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg) Ranibizumab 0.5 mg injection, Day 0 and Day 28 ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg) Ranibizumab 0.5 mg injection, Day 0 and Day 28 ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg) Ranibizumab 0.5 mg injection, Day 0 and Day 28
Period Title: Overall Study
Started 10 3 10 3 10 3 10 3
Completed 10 3 10 3 10 3 10 3
Not Completed 0 0 0 0 0 0 0 0
Arm/Group Title ESBA LUCENTIS Total
Hide Arm/Group Description All subjects who were treated with ESBA1008. All subjects who were treated with LUCENTIS. Total of all reporting groups
Overall Number of Baseline Participants 40 12 52
Hide Baseline Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables (BCVA and/or CSFT). Here, "n" is the number of subjects in each cohort for each arm group, respectively.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 12 participants 52 participants
Cohort 1, n=10, 3 77.5  (3.6) 78.3  (7.2) 77.7  (4.3)
Cohort 2, n=10, 3 73.6  (8.9) 82.0  (3.6) 75.5  (8.7)
Cohort 3, n=10, 3 76.5  (9.7) 81.7  (11.0) 77.7  (9.8)
Cohort 4, n=10, 3 81.6  (6.1) 76.7  (3.8) 80.5  (5.9)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 12 participants 52 participants
Cohort 1, Female 3 1 4
Cohort 1, Male 7 2 9
Cohort 2, Female 6 2 8
Cohort 2, Male 4 1 5
Cohort 3, Female 5 2 7
Cohort 3, Male 5 1 6
Cohort 4, Female 4 1 5
Cohort 4, Male 6 2 8
Best corrected visual acuity (BCVA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 40 participants 12 participants 52 participants
Cohort 1, n=10, 3 63.4  (6.8) 55.0  (8.7) 61.5  (7.8)
Cohort 2, n=10, 3 61.0  (11.8) 64.3  (6.8) 61.8  (10.7)
Cohort 3, n=10, 3 60.2  (14.7) 59.3  (5.1) 60.0  (12.9)
Cohort 4, n=10, 3 54.8  (14.2) 48.7  (16.9) 53.4  (14.4)
[1]
Measure Description: BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly out of 70 letters on the chart.
Central subfield thickness (CSFT)  
Mean (Standard Deviation)
Unit of measure:  Microns
Number Analyzed 40 participants 12 participants 52 participants
Cohort 1, n=10, 3 535.1  (194.7) 482.3  (104.3) 522.9  (175.5)
Cohort 2, n=10, 3 423.0  (95.5) 405.7  (19.9) 419.0  (83.5)
Cohort 3, n=10, 3 479.1  (93.7) 403.3  (67.7) 461.6  (91.9)
Cohort 4, n=10, 3 534.8  (123.4) 573.3  (160.6) 543.7  (126.5)
1.Primary Outcome
Title Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28
Hide Description

A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline:

  • Greater than or equal to 4 letter gain in BCVA at Day 14
  • Greater than or equal to 4 letter gain in BCVA at Day 28
  • Greater than or equal to 80 micron decrease in CSFT at Day 14
  • Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 14, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables (BCVA and/or CSFT). Here, "n" is the number of subjects in each arm group.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
Overall Number of Participants Analyzed 13 13 13 13
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of responders
ESBA, n=10
70
(39.3 to 91.3)
60
(30.4 to 85.0)
80
(49.3 to 96.3)
60
(30.4 to 85.0)
LUCENTIS, n=3
100
(36.8 to 100.0)
100
(36.8 to 100.0)
33.3
(1.7 to 86.5)
66.7
(13.5 to 98.3)
2.Secondary Outcome
Title Change From Baseline in BCVA, Cohort 1
Hide Description BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with last observation carried forward (LOCF) imputation for missing values.
Arm/Group Title ESBA 1.2 mg INJ LUCENTIS 0.5 mg INJ
Hide Arm/Group Description:
All subjects treated with ESBA 1008 1.2 mg IVT injection
All subjects treated with Ranibizumab 0.5 mg IVT injection
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: letters
Day 7 4.5  (6.5) 4.7  (7.4)
Day 14 5.9  (6.1) 6.3  (7.6)
Day 28 7.7  (5.2) 10.3  (6.1)
Day 42 10.3  (4.9) 8.3  (5.9)
Day 56 11.1  (8.0) 11.7  (5.5)
3.Secondary Outcome
Title Change From Baseline in BCVA, Cohort 2
Hide Description BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
Arm/Group Title ESBA 1 mg INF LUCENTIS 0.5 mg INJ
Hide Arm/Group Description:
All subjects treated with ESBA 1008 1 mg IVT infusion
All subjects treated with Ranibizumab 0.5 mg IVT injection
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: letters
Day 7 2.4  (6.2) 7.0  (13.0)
Day 14 4.8  (4.0) 7.3  (10.4)
Day 28 5.5  (6.0) 10.3  (11.2)
Day 42 8.1  (9.6) 10.3  (11.0)
Day 56 8.0  (7.3) 10.7  (10.8)
4.Secondary Outcome
Title Change From Baseline in BCVA, Cohort 3
Hide Description BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
Arm/Group Title ESBA 0.6 mg INJ LUCENTIS 0.5 mg INJ
Hide Arm/Group Description:
All subjects treated with ESBA 1008 0.6 mg IVT injection
All subjects treated with Ranibizumab 0.5 mg IVT injection
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: letters
Day 7 10.3  (9.0) 5.0  (4.6)
Day 14 9.8  (12.0) 7.3  (7.8)
Day 28 13.5  (10.4) 5.0  (6.9)
Day 42 15.0  (10.1) 6.0  (6.2)
Day 56 13.7  (9.9) 9.3  (1.5)
5.Secondary Outcome
Title Change From Baseline in BCVA, Cohort 4
Hide Description BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
Arm/Group Title ESBA 0.5 mg INF LUCENTIS 0.5 mg INJ
Hide Arm/Group Description:
All subjects treated with ESBA1008 0.5 mg IVT infusion
All subjects treated with Ranibizumab 0.5 mg IVT injection
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: letters
Day 7 3.2  (6.0) 9.3  (14.5)
Day 14 7.1  (7.6) 12.3  (11.8)
Day 28 4.7  (3.8) 11.7  (15.1)
Day 42 6.6  (5.3) 17.3  (17.9)
Day 56 7.6  (7.1) 18.7  (14.2)
6.Secondary Outcome
Title Change From Baseline in CSFT, Cohort 1
Hide Description CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
Arm/Group Title ESBA 1.2 mg INJ LUCENTIS 0.5 mg INJ
Hide Arm/Group Description:
All subjects treated with ESBA1008 1.2 mg IVT injection
All subjects treated with Ranibizumab 0.5 mg IVT injection
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: microns
Day 7 -114.0  (167.1) -99.7  (16.3)
Day 14 -188.2  (122.0) -130.3  (39.7)
Day 28 -182.0  (106.7) -175.3  (71.8)
Day 42 -221.0  (156.3) -183.7  (74.3)
Day 56 -226.3  (145.7) -162.7  (68.6)
7.Secondary Outcome
Title Change From Baseline in CSFT, Cohort 2
Hide Description CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
Arm/Group Title ESBA 1 mg INF LUCENTIS 0.5 mg INJ
Hide Arm/Group Description:
All subjects treated with ESBA1008 1 mg IVT infusion
All subjects treated with Ranibizumab 0.5 mg IVT injection
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: microns
Day 7 -57.9  (38.1) -87.7  (32.7)
Day 14 -96.5  (45.3) -116.0  (19.7)
Day 28 -104.9  (44.2) -142.3  (18.1)
Day 42 -133.1  (83.3) -148.3  (26.0)
Day 56 -137.9  (73.9) -155.0  (26.2)
8.Secondary Outcome
Title Change From Baseline in CSFT, Cohort 3
Hide Description CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
Arm/Group Title ESBA 0.6 mg INJ LUCENTIS 0.5 mg INJ
Hide Arm/Group Description:
All subjects treated with ESBA1008 0.6 mg IVT injection
All subjects treated with Ranibizumab 0.5 mg IVT injection
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: microns
Day 7 -93.4  (50.1) -54.0  (59.6)
Day 14 -126.8  (61.0) -85.7  (87.4)
Day 28 -163.1  (74.4) -104.0  (73.5)
Day 42 -194.4  (66.9) -128.3  (73.8)
Day 56 -205.4  (78.6) -108.7  (88.8)
9.Secondary Outcome
Title Change From Baseline in CSFT, Cohort 4
Hide Description CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
Arm/Group Title ESBA 0.5 mg INF LUCENTIS 0.5 mg INJ
Hide Arm/Group Description:
All subjects treated with ESBA1008 0.5 mg IVT infusion
All subjects treated with Ranibizumab 0.5 mg IVT injection
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: microns
Day 7 -102.8  (111.1) -105.3  (72.2)
Day 14 -119.9  (129.3) -194.3  (148.9)
Day 28 -125.1  (143.6) -187.3  (195.7)
Day 42 -184.2  (110.2) -253.0  (181.2)
Day 56 -203.5  (105.8) -213.7  (228.2)
Time Frame Adverse events (AEs) were collected for the duration of a subject’s participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
 
Arm/Group Title Stage 1 ESBA 1.2 mg INJ Stage 1 ESBA 1 mg INF Stage 1 LUCENTIS 0.5 mg INJ Stage 2 ESBA 0.6 mg INJ Stage 2 ESBA 0.5 mg INF Stage 2 LUCENTIS 0.5 mg INJ Pretreatment
Hide Arm/Group Description All subjects treated with ESBA1008 1.2 mg via injection All subjects treated with ESBA1008 1 mg via infusion All subjects treated with LUCENTIS via injection in Stage 1 All subjects treated with ESBA1008 0.6 mg via injection All subjects treated with ESBA1008 0.5 mg via infusion All subjects treated with LUCENTIS via injection in Stage 2 All subjects who consented to participate in the study prior to the initiation of study treatment
All-Cause Mortality
Stage 1 ESBA 1.2 mg INJ Stage 1 ESBA 1 mg INF Stage 1 LUCENTIS 0.5 mg INJ Stage 2 ESBA 0.6 mg INJ Stage 2 ESBA 0.5 mg INF Stage 2 LUCENTIS 0.5 mg INJ Pretreatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Stage 1 ESBA 1.2 mg INJ Stage 1 ESBA 1 mg INF Stage 1 LUCENTIS 0.5 mg INJ Stage 2 ESBA 0.6 mg INJ Stage 2 ESBA 0.5 mg INF Stage 2 LUCENTIS 0.5 mg INJ Pretreatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   1/6 (16.67%)   1/10 (10.00%)   0/10 (0.00%)   0/6 (0.00%)   1/107 (0.93%) 
Infections and infestations               
Pneumonia  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Injury, poisoning and procedural complications               
Pubis fracture  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Fall  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Vascular disorders               
Orthostatic hypotension  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/107 (0.93%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stage 1 ESBA 1.2 mg INJ Stage 1 ESBA 1 mg INF Stage 1 LUCENTIS 0.5 mg INJ Stage 2 ESBA 0.6 mg INJ Stage 2 ESBA 0.5 mg INF Stage 2 LUCENTIS 0.5 mg INJ Pretreatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/10 (60.00%)   4/10 (40.00%)   6/6 (100.00%)   6/10 (60.00%)   7/10 (70.00%)   4/6 (66.67%)   3/107 (2.80%) 
Endocrine disorders               
Androgen deficiency  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/107 (0.00%) 
Eye disorders               
Abnormal sensation in eye  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/107 (0.00%) 
Blepharitis  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/107 (0.00%) 
Chalazion  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Choroidal neovascularisation  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Conjunctival haemorrhage  1  1/10 (10.00%)  2/10 (20.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/6 (16.67%)  0/107 (0.00%) 
Conjunctival hyperaemia  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/107 (0.00%) 
Conjunctival oedema  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/107 (0.00%) 
Corneal epithelium defect  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Eye irritation  1  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Eye pain  1  0/10 (0.00%)  1/10 (10.00%)  1/6 (16.67%)  1/10 (10.00%)  2/10 (20.00%)  0/6 (0.00%)  0/107 (0.00%) 
Eye pruritus  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Eyelid pain  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Eyelids pruritus  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Foreign body sensation in eyes  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Metamorphopsia  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Ocular discomfort  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Retinal haemorrhage  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/107 (0.00%) 
Retinal pigment epitheliopathy  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/107 (0.00%) 
Vision blurred  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Visual impairment  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Vitreous floaters  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  1/6 (16.67%)  0/107 (0.00%) 
Xanthopsia  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Gastrointestinal disorders               
Dental caries  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Diarrhoea  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Dysphagia  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Nausea  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/107 (0.00%) 
Toothache  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/107 (0.00%) 
Immune system disorders               
Seasonal allergy  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/107 (0.00%) 
Infections and infestations               
Bronchitis  1  2/10 (20.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Keratitis bacterial  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Nasopharyngitis  1  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Tooth abscess  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Upper respiratory tract infection  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/107 (0.00%) 
Injury, poisoning and procedural complications               
Fall  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Traumatic haemorrhage  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Investigations               
Biopsy ear  1  0/10 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Blood pressure increased  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Metabolism and nutrition disorders               
Diabetes mellitus  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/107 (0.93%) 
Hypercholesterolaemia  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/107 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/107 (0.93%) 
Arthritis  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  1/107 (0.93%) 
Osteoporosis  1  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Basal cell carcinoma  1  0/10 (0.00%)  0/10 (0.00%)  2/6 (33.33%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Seborrhoeic keratosis  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/6 (0.00%)  0/107 (0.00%) 
Vascular disorders               
Hypertension  1  0/10 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/6 (16.67%)  1/107 (0.93%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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: Clinical Project Group Leader, GCRA, Pharma
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: NCT01849692    
Other Study ID Numbers: C-13-001
First Submitted: May 6, 2013
First Posted: May 8, 2013
Results First Submitted: January 29, 2016
Results First Posted: February 25, 2016
Last Update Posted: March 24, 2016