A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

Sponsor
Faes Farma, S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT03479307
Collaborator
ORA, Inc. (Industry)
228
6
3
4.1
38
9.3

Study Details

Study Description

Brief Summary

To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bilastine Ophthalmic Solution 0.6%
  • Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)
  • Drug: Vehicle of Bilastine Ophthalmic Solution
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Double-Masked, Randomized, Vehicle- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Bilastine Ophthalmic Solution 0.6% Compared to Vehicle and Zaditen (Ketotifen Ophthalmic Solution 0.025%) for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
Actual Study Start Date :
Apr 7, 2018
Actual Primary Completion Date :
Aug 9, 2018
Actual Study Completion Date :
Aug 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bilastine Ophthalmic Solution 0.6%

Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period.

Drug: Bilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.

Active Comparator: Ketotifen Ophthalmic Solution 0.025% (Zaditen)

Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period.

Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period.
Other Names:
  • Zaditen
  • Placebo Comparator: Vehicle of Bilastine Ophthalmic Solution

    Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period.

    Drug: Vehicle of Bilastine Ophthalmic Solution
    1 drop in each eye at 2 separate times during an 8 day period.

    Outcome Measures

    Primary Outcome Measures

    1. Ocular Itching [The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).]

      The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • be at least 18 years old

    • be willing and able to avoid all disallowed medications and contact lenses

    • must have a pregnancy test if of childbearing potential

    • must be able to read an eye chart from 10 feet away

    Exclusion Criteria:
    • must not have any allergies to the study medications

    • must not have any ocular or non ocular condition that investigator feels will interfere with study parameters

    • must not have used immunotherapy in the last 2 years

    • must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cornea Consultants of AZ Phoenix Arizona United States 85032
    2 East West Eye Institute Torrance California United States 90505
    3 Andover Eye Associates Andover Massachusetts United States 01810
    4 Apex Eye Mason Ohio United States 45040
    5 Philadelphia Eye Associates Philadelphia Pennsylvania United States 19134
    6 Total Eye Care, P.A. Memphis Tennessee United States 38119

    Sponsors and Collaborators

    • Faes Farma, S.A.
    • ORA, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Faes Farma, S.A.
    ClinicalTrials.gov Identifier:
    NCT03479307
    Other Study ID Numbers:
    • BOFT-0218/AC-CAC
    First Posted:
    Mar 27, 2018
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Bilastine Ophthalmic Solution 0.6% Ketotifen Ophthalmic Solution 0.025% (Zaditen) Vehicle of Bilastine Ophthalmic Solution
    Arm/Group Description Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period. Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period. Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
    Period Title: Overall Study
    STARTED 91 90 47
    COMPLETED 90 89 47
    NOT COMPLETED 1 1 0

    Baseline Characteristics

    Arm/Group Title Bilastine Ophthalmic Solution 0.6% Ketotifen Ophthalmic Solution 0.025% (Zaditen) Vehicle of Bilastine Ophthalmic Solution Total
    Arm/Group Description Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period. Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period. Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. Total of all reporting groups
    Overall Participants 91 90 47 228
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    85
    93.4%
    89
    98.9%
    43
    91.5%
    217
    95.2%
    >=65 years
    6
    6.6%
    1
    1.1%
    4
    8.5%
    11
    4.8%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    45.9
    (12.88)
    41.7
    (12.1)
    45.1
    (16.03)
    44.1
    (13.38)
    Sex: Female, Male (Count of Participants)
    Female
    58
    63.7%
    53
    58.9%
    25
    53.2%
    136
    59.6%
    Male
    33
    36.3%
    37
    41.1%
    22
    46.8%
    92
    40.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    11
    12.1%
    10
    11.1%
    6
    12.8%
    27
    11.8%
    Not Hispanic or Latino
    80
    87.9%
    79
    87.8%
    41
    87.2%
    200
    87.7%
    Unknown or Not Reported
    0
    0%
    1
    1.1%
    0
    0%
    1
    0.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    1.1%
    1
    1.1%
    1
    2.1%
    3
    1.3%
    Asian
    14
    15.4%
    13
    14.4%
    6
    12.8%
    33
    14.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    25
    27.5%
    27
    30%
    14
    29.8%
    66
    28.9%
    White
    49
    53.8%
    48
    53.3%
    26
    55.3%
    123
    53.9%
    More than one race
    2
    2.2%
    1
    1.1%
    0
    0%
    3
    1.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    91
    100%
    90
    100%
    47
    100%
    228
    100%
    Ocular Itching- Baseline (units on a scale) [Mean (Standard Deviation) ]
    Visit 4b: Pre-CAC
    0.014
    (0.0945)
    0.011
    (0.1054)
    0.043
    (0.2949)
    0.023
    (0.1649)
    Visit 5: Pre-CAC
    0.000
    (0.0000)
    0.000
    (0.0000)
    0.000
    (0.0000)
    0.000
    (0.0000)

    Outcome Measures

    1. Primary Outcome
    Title Ocular Itching
    Description The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub).
    Time Frame The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bilastine Ophthalmic Solution 0.6% Ketotifen Ophthalmic Solution 0.025% (Zaditen) Vehicle of Bilastine Ophthalmic Solution
    Arm/Group Description Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period. Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period. Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
    Measure Participants 91 90 47
    Visit 4b: 3 minutes Post- CAC
    1.609
    (0.9013)
    1.886
    (0.9504)
    2.219
    (0.9644)
    Visit 4b: 5 minutes Post- CAC
    1.750
    (0.9508)
    1.919
    (0.9670)
    2.490
    (0.8996)
    Visit 4b: 7 minutes Post- CAC
    1.747
    (1.0283)
    1.894
    (0.9606)
    2.526
    (0.9035)
    Visit 5: 3 minutes Post- CAC
    0.669
    (0.7926)
    0.658
    (0.6745)
    1.840
    (0.9258)
    Visit 5: 5 minutes Post- CAC
    0.828
    (0.8879)
    0.902
    (0.8208)
    2.011
    (0.9058)
    Visit 5: 7 minutes Post- CAC
    0.826
    (0.8901)
    0.981
    (0.9224)
    1.931
    (0.8703)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bilastine Ophthalmic Solution 0.6%, Vehicle of Bilastine Ophthalmic Solution
    Comments Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 4b (including all time points).
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.710
    Confidence Interval (2-Sided) 95%
    -1.013 to -0.407
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Bilastine Ophthalmic Solution 0.6%, Vehicle of Bilastine Ophthalmic Solution
    Comments Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.167
    Confidence Interval (2-Sided) 95%
    -1.439 to -0.895
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ketotifen Ophthalmic Solution 0.025% (Zaditen), Vehicle of Bilastine Ophthalmic Solution
    Comments Treatment Difference (95% CI): Ketotifen Ophthalmic Solution 0.025% (Zaditen) arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.140
    Confidence Interval (2-Sided) 95%
    -1.413 to -0.868
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen)
    Comments Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 3 minutes Post-CAC (non-inferiority test).
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority margin of 0.40
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.009
    Confidence Interval (1-Sided) 97.5%
    to 0.235
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen)
    Comments Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 5 minutes Post-CAC (non-inferiority test).
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority margin of 0.40
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.077
    Confidence Interval (1-Sided) 97.5%
    to 0.175
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen)
    Comments Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 7 minutes Post-CAC (non-inferiority test).
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority margin of 0.40
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.159
    Confidence Interval (1-Sided) 97.5%
    to 0.101
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
    Adverse Event Reporting Description
    Arm/Group Title Bilastine Ophthalmic Solution 0.6% Ketotifen Ophthalmic Solution 0.025% (Zaditen) Vehicle of Bilastine Ophthalmic Solution
    Arm/Group Description Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period. Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period. Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
    All Cause Mortality
    Bilastine Ophthalmic Solution 0.6% Ketotifen Ophthalmic Solution 0.025% (Zaditen) Vehicle of Bilastine Ophthalmic Solution
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/91 (0%) 0/90 (0%) 0/47 (0%)
    Serious Adverse Events
    Bilastine Ophthalmic Solution 0.6% Ketotifen Ophthalmic Solution 0.025% (Zaditen) Vehicle of Bilastine Ophthalmic Solution
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/91 (0%) 0/90 (0%) 0/47 (0%)
    Other (Not Including Serious) Adverse Events
    Bilastine Ophthalmic Solution 0.6% Ketotifen Ophthalmic Solution 0.025% (Zaditen) Vehicle of Bilastine Ophthalmic Solution
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/91 (4.4%) 2/90 (2.2%) 1/47 (2.1%)
    Eye disorders
    Visual Acuty Reduced 3/91 (3.3%) 0/90 (0%) 0/47 (0%)
    Infections and infestations
    Conjunctivitis 0/91 (0%) 1/90 (1.1%) 0/47 (0%)
    Hordeolum 0/91 (0%) 1/90 (1.1%) 0/47 (0%)
    Sinusitis 1/91 (1.1%) 0/90 (0%) 0/47 (0%)
    Tooth Abscess 0/91 (0%) 0/90 (0%) 1/47 (2.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    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.

    Results Point of Contact

    Name/Title Nieves Fernández, MD, PhD
    Organization Faes Farma
    Phone +34 94 481 83 00
    Email nfernandez@faes.es
    Responsible Party:
    Faes Farma, S.A.
    ClinicalTrials.gov Identifier:
    NCT03479307
    Other Study ID Numbers:
    • BOFT-0218/AC-CAC
    First Posted:
    Mar 27, 2018
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Nov 1, 2021