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LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration

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: NCT02355028
Recruitment Status : Completed
First Posted : February 4, 2015
Results First Posted : November 14, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Exudative Age-Related Macular Degeneration
Interventions Drug: LHA510 ophthalmic suspension
Drug: LHA510 vehicle
Drug: Ranibizumab ophthalmic solution
Enrollment 136
Recruitment Details Subjects were recruited from 20 study centers located in the United States.
Pre-assignment Details Of the 136 enrolled, 37 subjects were exited as screen failures and another 6 subjects were discontinued prior to randomization. This reporting group includes all randomized subjects (93).
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Period Title: Overall Study
Started 47 46
Treated 46 45
Completed 36 41
Not Completed 11 5
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             1             1
Deemed ineligible after randomization             8             4
Arm/Group Title LHA510 Vehicle Total
Hide Arm/Group Description LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. Total of all reporting groups
Overall Number of Baseline Participants 46 45 91
Hide Baseline Analysis Population Description
This analysis population includes all subjects who received any dose of investigational product (IP) (Safety Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 45 participants 91 participants
77.3  (7.74) 76.8  (7.94) 77.1  (7.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 91 participants
Female
22
  47.8%
28
  62.2%
50
  54.9%
Male
24
  52.2%
17
  37.8%
41
  45.1%
Central Subfield Thickness Total (CSFTtot)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  μm
Number Analyzed 33 participants 37 participants 70 participants
350.5  (107.09) 374.9  (116.98) 363.4  (112.29)
[1]
Measure Description: The thickness of the retina was measured using spectral domain-optical coherence tomography (SD-OCT) and reported in micrometers.
[2]
Measure Analysis Population Description: All subjects who met amendment 4 entry criteria, received any dose of IP, had at least 1 follow-up visit with an assessment for primary endpoint, and had no critical protocol deviations, or discontinued the study due to lack of efficacy or tolerability before Day 84 (Extended PPS-A4).
Best-corrected visual acuity (BCVA)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 33 participants 37 participants 70 participants
71.2  (9.45) 70.5  (8.87) 70.9  (9.09)
[1]
Measure Description: Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity was conducted in each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and reported in number of letters read correctly.
[2]
Measure Analysis Population Description: Extended PPS-A4
Central Subfield Thickness Neuro-Retina (CSFTnr)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  μm
Number Analyzed 33 participants 37 participants 70 participants
242.2  (48.95) 239.0  (75.87) 240.5  (64.17)
[1]
Measure Description: The thickness of the neuro-retina, at the level of the central subfield, was measured using SD-OCT and reported in micrometers.
[2]
Measure Analysis Population Description: Extended PPS-A4
Lesion Thickness   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  μm
Number Analyzed 33 participants 37 participants 70 participants
20.3  (37.90) 45.8  (92.83) 33.8  (72.99)
[1]
Measure Description: The thickness of the neovascular lesion was measured using SD-OCT and reported in micrometers.
[2]
Measure Analysis Population Description: Extended PPS-A4
Subretinal Fluid-Foveal Involvement (SRFfi) Thickness   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  μm
Number Analyzed 33 participants 37 participants 70 participants
40.7  (58.81) 25.0  (50.76) 32.4  (54.87)
[1]
Measure Description: The thickness of subretinal fluid involving the fovea was measured using SD-OCT and reported in micrometers.
[2]
Measure Analysis Population Description: Extended PPS-A4
Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  μm
Number Analyzed 33 participants 37 participants 70 participants
60.9  (92.26) 82.6  (100.07) 72.4  (96.39)
[1]
Measure Description: The thickness of pigment epithelial detachment involving the fovea was measured using SD-OCT and reported in micrometers.
[2]
Measure Analysis Population Description: Extended PPS-A4
Total Lesion Size   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mm^2
Number Analyzed 32 participants 35 participants 67 participants
6.1  (4.73) 7.8  (5.74) 7.0  (5.31)
[1]
Measure Description: The total neovascular lesion size was measured by fluorescein angiography (FA) assessment and reported in millimeters squared.
[2]
Measure Analysis Population Description: Extended PPS-A4
Choroidal Neovascularization (CNV) Size   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mm^2
Number Analyzed 32 participants 35 participants 67 participants
6.0  (4.79) 7.7  (5.72) 6.9  (5.33)
[1]
Measure Description: CNV (creation of new blood vessels in the choroid layer of the eye) size as measured by FA assessment and reported in millimeters squared.
[2]
Measure Analysis Population Description: Extended PPS-A4
1.Primary Outcome
Title Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84
Hide Description For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Measure Type: Count of Participants
Unit of Measure: Participants
25
  75.8%
25
  67.6%
2.Secondary Outcome
Title Time to First LUCENTIS® Retreatment Need Identification up to Day 84
Hide Description The time was determined based on the visit of the treatment period when a patient was identified as requiring retreatment with LUCENTIS.
Time Frame Day 14, Day 28, Day 56, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4 who required retreatment
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Day 14
0
   0.0%
0
   0.0%
Day 28
5
  20.0%
8
  32.0%
Day 56
16
  64.0%
11
  44.0%
Day 84
4
  16.0%
6
  24.0%
3.Secondary Outcome
Title Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84
Hide Description The number of LUCENTIS retreatment needs identified before or at the Day 84 visit (even if retreatment was applied at a later visit) for each patient was used in the analysis
Time Frame Up to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Measure Type: Number
Unit of Measure: participants
0 retreatment injections 8 12
1 retreatment injection 18 18
2 retreatment injections 6 6
3 retreatment injections 1 1
4.Secondary Outcome
Title Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56
Hide Description The number of LUCENTIS® retreatment needs identified before or at the Day 28 and Day 56 visits (even if retreatment was applied at a later visit) for each subject was used in the analysis.
Time Frame Day 28, Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Measure Type: Count of Participants
Unit of Measure: Participants
Day 28
5
  15.2%
8
  21.6%
Day 56
21
  63.6%
19
  51.4%
5.Secondary Outcome
Title Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site
Hide Description The thickness of the retina was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time Frame Day -1, Day 14, Day 28, Day 56, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4. Missing data imputed using the Last Observation Carried Forward (LOCF) approach.
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Least Squares Mean (Standard Error)
Unit of Measure: μm
Day 14 -46.9  (8.40) -43.0  (7.93)
Day 28 -38.6  (7.42) -28.9  (7.00)
Day 56 11.3  (10.01) 1.0  (9.45)
Day 84 -16.8  (8.92) -12.2  (8.42)
6.Secondary Outcome
Title Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site
Hide Description Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity was conducted in each eye individually using ETDRS charts and reported in number of letters read correctly. An increase (gain) in letters read from the baseline assessment indicates improvement. Only one eye (study eye) contributed to the analysis.
Time Frame Day -1, Day 14, Day 28, Day 56, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4. Missing Data Imputed Using LOCF.
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Least Squares Mean (Standard Error)
Unit of Measure: letters
Day 14 1.3  (0.80) 1.6  (0.75)
Day 28 1.7  (0.89) 2.5  (0.84)
Day 56 -0.5  (1.28) 2.3  (1.21)
Day 84 -1.7  (1.59) 2.2  (1.50)
7.Secondary Outcome
Title Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit
Hide Description The thickness of the neuro-retina, at the level of the central subfield, was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time Frame Day -1, Day 28, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4. Missing data imputed using LOCF.
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Mean (Standard Deviation)
Unit of Measure: μm
Day 28 -16.6  (22.62) -15.1  (38.21)
Day 84 -4.1  (35.34) -8.8  (36.75)
8.Secondary Outcome
Title Change From Randomization Visit (Day -1) in Lesion Thickness by Visit
Hide Description The thickness of the neovascular lesion was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of the neovascular lesion may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time Frame Day -1, Day 28, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4. Missing data imputed using LOCF.
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Mean (Standard Deviation)
Unit of Measure: μm
Day 28 -1.9  (38.05) 6.9  (43.66)
Day 84 1.4  (26.46) 6.9  (43.96)
9.Secondary Outcome
Title Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit
Hide Description The thickness of subretinal fluid involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of subretinal fluid involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time Frame Day -1, Day 28, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4. Missing Data Imputed Using LOCF.
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Mean (Standard Deviation)
Unit of Measure: μm
Day 28 -18.5  (44.67) -11.0  (34.73)
Day 84 -14.1  (54.08) -5.9  (31.33)
10.Secondary Outcome
Title Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit
Hide Description The thickness of pigment epithelial detachment involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of pigment epithelial detachment involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time Frame Day -1, Day 28, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4. Missing Data Imputed Using LOCF.
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 33 37
Mean (Standard Deviation)
Unit of Measure: μm
Day 28 -0.3  (38.92) -13.3  (43.23)
Day 84 -0.2  (33.33) -7.6  (47.25)
11.Secondary Outcome
Title Change From Randomization Visit (Day -1) in Total Lesion Size by Visit
Hide Description The total wet AMD lesion size was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in wet AMD lesion size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time Frame Day -1, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4 as observed
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 32 35
Mean (Standard Deviation)
Unit of Measure: mm^2
-0.3  (1.71) 0.5  (1.81)
12.Secondary Outcome
Title Change From Randomization Visit (Day -1) in CNV Size by Visit
Hide Description The size of CNV (area of new blood vessels in the choroid layer of the retina) was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in CNV size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time Frame Day -1, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Extended PPS-A4 as observed
Arm/Group Title LHA510 Vehicle
Hide Arm/Group Description:
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Overall Number of Participants Analyzed 32 35
Mean (Standard Deviation)
Unit of Measure: mm^2
-0.6  (2.00) 0.5  (1.71)
13.Secondary Outcome
Title Plasma Concentration of LHA510 and CRA398
Hide Description Samples collected from subjects, after multiple topical ocular dosing of LHA510, were analyzed to determine concentrations of LHA510 and its metabolite, CRA398. Plasma LHA510 and CRA398 concentrations were quantitated by a validated liquid chromatography-tandem mass spectroscopy assay method. Below the limit of quantification (BLQ) is treated as zero.
Time Frame Day 28, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were treated with LHA510, had at least 1 serum sample following exposure to the IP, and had no known specimen collection or analytical deviations, as identified by the Pharmacokineticist, that would have affected the integrity of the data [Pharmacokinetics (PK) Analysis Set].
Arm/Group Title LHA510 CRA398
Hide Arm/Group Description:
LHA510 dose twice daily (BID) by Day 28, LHA510 dose once daily (QD) by Day 84, LHA510 dose 3-times daily (TID) by Day 84
Metabolite of LHA510
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 28, BID Number Analyzed 31 participants 31 participants
0.0746  (0.0483) 0.0257  (0.0287)
Day 84, QD Number Analyzed 6 participants 6 participants
0.0403  (0.0225) 0  (0)
Day 84, TID Number Analyzed 10 participants 10 participants
0.0694  (0.0439) 0.0160  (0.0179)
Time Frame Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
 
Arm/Group Title Pre-treatment LHA510 Vehicle Post-treatment LHA510 Post-treatment Vehicle
Hide Arm/Group Description All subjects with AE/s reported prior to the initiation of IP administration All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
All-Cause Mortality
Pre-treatment LHA510 Vehicle Post-treatment LHA510 Post-treatment Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/136 (0.00%)   0/46 (0.00%)   0/45 (0.00%)   0/46 (0.00%)   0/45 (0.00%) 
Hide Serious Adverse Events
Pre-treatment LHA510 Vehicle Post-treatment LHA510 Post-treatment Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/136 (0.00%)   1/46 (2.17%)   0/45 (0.00%)   1/46 (2.17%)   0/45 (0.00%) 
Cardiac disorders           
Acute myocardial infarction  1  0/136 (0.00%)  0/46 (0.00%)  0/45 (0.00%)  1/46 (2.17%)  0/45 (0.00%) 
Angina pectoris  1  0/136 (0.00%)  1/46 (2.17%)  0/45 (0.00%)  0/46 (0.00%)  0/45 (0.00%) 
Cardiac failure congestive  1  0/136 (0.00%)  0/46 (0.00%)  0/45 (0.00%)  1/46 (2.17%)  0/45 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Bronchial hyperreactivity  1  0/136 (0.00%)  0/46 (0.00%)  0/45 (0.00%)  1/46 (2.17%)  0/45 (0.00%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-treatment LHA510 Vehicle Post-treatment LHA510 Post-treatment Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/136 (0.74%)   28/46 (60.87%)   5/45 (11.11%)   3/46 (6.52%)   0/45 (0.00%) 
Eye disorders           
Corneal oedema  1  0/136 (0.00%)  8/46 (17.39%)  0/45 (0.00%)  0/46 (0.00%)  0/45 (0.00%) 
Corneal opacity  1  0/136 (0.00%)  20/46 (43.48%)  0/45 (0.00%)  0/46 (0.00%)  0/45 (0.00%) 
Eye irritation  1  0/136 (0.00%)  5/46 (10.87%)  3/45 (6.67%)  0/46 (0.00%)  0/45 (0.00%) 
Eye pain  1  1/136 (0.74%)  3/46 (6.52%)  0/45 (0.00%)  0/46 (0.00%)  0/45 (0.00%) 
Keratopathy  1  0/136 (0.00%)  5/46 (10.87%)  0/45 (0.00%)  0/46 (0.00%)  0/45 (0.00%) 
Vision blurred  1  0/136 (0.00%)  6/46 (13.04%)  1/45 (2.22%)  1/46 (2.17%)  0/45 (0.00%) 
Visual acuity reduced  1  0/136 (0.00%)  3/46 (6.52%)  0/45 (0.00%)  0/46 (0.00%)  0/45 (0.00%) 
Investigations           
Vital dye staining cornea present  1  0/136 (0.00%)  4/46 (8.70%)  2/45 (4.44%)  1/46 (2.17%)  0/45 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  0/136 (0.00%)  3/46 (6.52%)  0/45 (0.00%)  1/46 (2.17%)  0/45 (0.00%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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 Scientist, NIBR
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research ( Alcon, a Novartis Company )
ClinicalTrials.gov Identifier: NCT02355028    
Other Study ID Numbers: LHA510-2201
First Submitted: January 28, 2015
First Posted: February 4, 2015
Results First Submitted: October 11, 2017
Results First Posted: November 14, 2017
Last Update Posted: July 2, 2018