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CompletedNCT03231969Updated Mar 16, 2023Results posted

A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model

A Phase 2 interventional study of Bilastine 0.2% and Bilastine 0.4% in Allergic Conjunctivitis, sponsored by Faes Farma, S.A.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by Faes Farma, S.A. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis

02

Conditions studied

  • Allergic Conjunctivitis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key 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

Key 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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    Bilastine 0.2%

    Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period.

    Drug: Bilastine 0.2%

  • Experimental
    Bilastine 0.4%

    Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period.

    Drug: Bilastine 0.4%

  • Experimental
    Bilastine 0.6%

    Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period.

    Drug: Bilastine 0.6%

  • Placebo comparator
    Bilastine 0%

    Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period.

    Drug: Bilastine 0%

Interventions

  • DrugBilastine 0.2%

    1 drop in each eye at 3 separate times during a 25 day period.

  • DrugBilastine 0.4%

    1 drop in each eye at 3 separate times during a 25 day period.

  • DrugBilastine 0.6%

    1 drop in each eye at 3 separate times during a 25 day period.

  • DrugBilastine 0%

    1 drop in each eye at 3 separate times during a 25 day period.

05

What researchers measure

Primary outcomes

  1. Ocular Itching

    The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.

    Time frame: The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).

06

Results

Posted Nov 24, 2021

Participant flow

Participant flow — Overall Study
MilestoneBilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%
Started30303130
Completed28283030
Not completed2210

Outcome measures

PrimaryOcular Itching

The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.

Time frame:
The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).
Reported as:
Mean · units on a scale
Ocular Itching
units on a scaleBilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0% (Vehicle)
Visit 4b: 3 minutes Post-CAC1.908 ± 0.78091.925 ± 0.94491.177 ± 1.03322.758 ± 0.7146
Visit 4b: 5 minutes Post-CAC2.075 ± 0.78282.117 ± 0.95311.218 ± 1.12683.017 ± 0.5979
Visit 4b: 7 minutes Post-CAC2.092 ± 0.76982.100 ± 1.07601.218 ± 1.11572.917 ± 0.5884
Visit 5b: 3 minutes Post-CAC1.397 ± 1.10501.250 ± 0.88720.708 ± 0.89082.558 ± 0.8032
Visit 5b: 5 minutes Post-CAC1.466 ± 0.93001.464 ± 0.95920.817 ± 1.05032.642 ± 0.7505
Visit 5b: 7 minutes Post-CAC1.379 ± 0.85731.518 ± 1.03400.742 ± 0.98372.642 ± 0.7704
Visit 6: 3 minutes Post-CAC0.679 ± 0.66620.732 ± 0.91270.392 ± 0.57492.542 ± 0.8384
Visit 6: 5 minutes Post-CAC0.920 ± 0.72351.143 ± 0.99870.558 ± 0.63552.592 ± 0.8343
Visit 6: 7 minutes Post-CAC1.000 ± 0.74541.214 ± 0.94210.583 ± 0.67062.483 ± 0.9024
Statistical analysis
  • Bilastine 0.2% vs Bilastine 0% (Vehicle) · ANCOVA · p = 0.0002 · Mean difference (final values): -0.791 · 95% CI -1.203 to -0.378
  • Bilastine 0.4% vs Bilastine 0% (Vehicle) · ANCOVA · p = <.0001 · Mean difference (final values): -0.851 · 95% CI -1.263 to -0.439
  • Bilastine 0.6% vs Bilastine 0% (Vehicle) · ANCOVA · p = <.0001 · Mean difference (final values): -1.545 · 95% CI -1.954 to -1.135
  • Bilastine 0.2% vs Bilastine 0% (Vehicle) · ANCOVA · p = <.0001 · Mean difference (final values): -1.208 · 95% CI -1.639 to -0.778
  • Bilastine 0.4% vs Bilastine 0% (Vehicle) · ANCOVA · p = <.0001 · Mean difference (final values): -1.245 · 95% CI -1.679 to -0.811
  • Bilastine 0.6% vs Bilastine 0% (Vehicle) · ANCOVA · p = <.0001 · Mean difference (final values): -1.846 · 95% CI -2.273 to -1.418
  • Bilastine 0.2% vs Bilastine 0% (Vehicle) · ANCOVA · p = <.0001 · Mean difference (final values): -1.696 · 95% CI -2.080 to -1.312
  • Bilastine 0.4% vs Bilastine 0% (Vehicle) · ANCOVA · p = <.0001 · Mean difference (final values): -1.617 · 95% CI -2.001 to -1.232
  • Bilastine 0.6% vs Bilastine 0% (Vehicle) · ANCOVA · p = <.0001 · Mean difference (final values): -2.009 · 95% CI -2.387 to -1.630

Adverse events

Collected over Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bilastine 0.2%0/30 (0%)0/30 (0%)8/30 (26.7%)
Bilastine 0.4%0/30 (0%)0/30 (0%)3/30 (10%)
Bilastine 0.6%0/31 (0%)0/31 (0%)1/31 (3.2%)
Bilastine 0%0/30 (0%)0/30 (0%)7/30 (23.3%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventBilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%
Viral Upper Respiratory Tract InfectionInfections and infestations1/301/300/313/30
Visual Acuity ReducedEye disorders2/300/300/310/30
BlepharitisEye disorders1/300/300/310/30
Corneal DepositsEye disorders0/300/300/311/30
Eye DischargeEye disorders0/300/300/311/30
KeratitisEye disorders0/301/300/310/30
Macular FibrosisEye disorders1/300/300/310/30
HordeolumInfections and infestations1/300/300/310/30
Gastroenteritis ViralInfections and infestations0/300/300/311/30
HeadacheNervous system disorders0/301/300/310/30

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Bilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%Total
<=18 years00000
Between 18 and 65 years28272727109
>=65 years234312
Age, Continuous
Age, Continuous(years)Bilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%Total
Mean50.4 ± 10.747.0 ± 13.9551.8 ± 13.448.3 ± 13.2449.4 ± 12.8
Sex: Female, Male
Sex: Female, Male(Participants)Bilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%Total
Female1618151766
Male1412161355
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Bilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%Total
Hispanic or Latino374519
Not Hispanic or Latino27232725102
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Bilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%Total
American Indian or Alaska Native01001
Asian10102
Native Hawaiian or Other Pacific Islander00000
Black or African American124310
White27272627107
More than one race10001
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)Bilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%Total
United States30303130121
Ocular Itching- Baseline
Ocular Itching- Baseline(units on a scale)Bilastine 0.2%Bilastine 0.4%Bilastine 0.6%Bilastine 0%Total
Visit 4b: Pre- CAC0.058 ± 0.20430.000 ± 0.00000.048 ± 0.19810.025 ± 0.10060.03275 ± 0.12575
Visit 5b: Pre- CAC0.000 ± 0.00000.000 ± 0.00000.033 ± 0.18260.033 ± 0.18260.0165 ± 0.0913
Visit 6: Pre- CAC0.000 ± 0.00000.000 ± 0.00000.000 ± 0.00000.000 ± 0.00000.000 ± 0.0000
07

Study locations

1 site
  • Ora Clinical Research Center
    Andover, Massachusetts 01810, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 28, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03231969
Lead sponsor
Faes Farma, S.A.
Collaborators
ORA, Inc.
Responsible party
Sponsor
First posted
Jul 27, 2017
Start date
Jul 20, 2017
Primary completion
Oct 11, 2017
Completion
Oct 11, 2017
Results posted
Nov 24, 2021
Last update
Mar 16, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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