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Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease

Sponsor
Allergan (Industry)
Overall Status
Terminated
CT.gov ID
NCT02013791
Collaborator
(none)
55
Enrollment
8
Locations
9
Arms
35.4
Actual Duration (Months)
6.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vehicle
  • Other: Sham
  • Drug: Cyclosporine New Ophthalmic Formulation
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease
Actual Study Start Date :
Apr 29, 2014
Actual Primary Completion Date :
Apr 12, 2017
Actual Study Completion Date :
Apr 12, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Stage 1 Cohort 1

Vehicle administered to study eye and Sham administered to non-study eye on Day 1.

Drug: Vehicle
Vehicle of cyclosporine administered as per protocol

Other: Sham
Sham administered to non-study eye as per protocol on Day 1
Experimental: Stage 1 Cohort 2

Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.

Drug: Vehicle
Vehicle of cyclosporine administered as per protocol

Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X

    		•
    Experimental: Stage 1 Cohort 3

    Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.

    Drug: Vehicle
    Vehicle of cyclosporine administered as per protocol

    Drug: Cyclosporine New Ophthalmic Formulation
    Cyclosporine New Ophthalmic Formulation administered as per protocol
    Other Names:
  • RESTASIS® X

    		•
    Experimental: Stage 1 Cohort 4

    Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.

    Drug: Vehicle
    Vehicle of cyclosporine administered as per protocol

    Drug: Cyclosporine New Ophthalmic Formulation
    Cyclosporine New Ophthalmic Formulation administered as per protocol
    Other Names:
  • RESTASIS® X

    		•
    Experimental: Stage 1 Cohort 5A

    Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.

    Drug: Vehicle
    Vehicle of cyclosporine administered as per protocol

    Drug: Cyclosporine New Ophthalmic Formulation
    Cyclosporine New Ophthalmic Formulation administered as per protocol
    Other Names:
  • RESTASIS® X

    		•
    Experimental: Stage 1 Cohort 6A

    Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.

    Drug: Vehicle
    Vehicle of cyclosporine administered as per protocol

    Drug: Cyclosporine New Ophthalmic Formulation
    Cyclosporine New Ophthalmic Formulation administered as per protocol
    Other Names:
  • RESTASIS® X

    		•
    Experimental: Stage 1 Cohort 6B

    Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.

    Drug: Vehicle
    Vehicle of cyclosporine administered as per protocol

    Drug: Cyclosporine New Ophthalmic Formulation
    Cyclosporine New Ophthalmic Formulation administered as per protocol
    Other Names:
  • RESTASIS® X

    		•
    Experimental: Stage 1 Cohort 6C

    Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.

    Drug: Vehicle
    Vehicle of cyclosporine administered as per protocol

    Drug: Cyclosporine New Ophthalmic Formulation
    Cyclosporine New Ophthalmic Formulation administered as per protocol
    Other Names:
  • RESTASIS® X

    		•
    Experimental: Stage 1 Cohort 6D

    Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.

    Drug: Vehicle
    Vehicle of cyclosporine administered as per protocol

    Drug: Cyclosporine New Ophthalmic Formulation
    Cyclosporine New Ophthalmic Formulation administered as per protocol
    Other Names:
  • RESTASIS® X

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [First dose of study drug to up to 24 Weeks]

      An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.

    Other Outcome Measures

    1. Change From Baseline in Corneal Staining Score Using a 6-Point Scale [Baseline (Day 1) to Week 12]

      Total corneal staining with sodium fluorescein was measured in the study eye using the 6-point Oxford scale [Grade 0: <2 dots (best), Grade 1: ≥2 to ≤10 dots, Grade 2: >10 to ≤32 dots, Grade 3: >32 to ≤100 dots, Grade 4: >100 to ≤316 dots and Grade 5: >316 dots or ulcer/erosion (worst)]. The study eye was defined as the eye that received the dosing level of the treatment received. A negative change from Baseline represents a decrease in staining (improvement). Corneal Staining Score was originally registered as a Primary endpoint but it is actually an exploratory endpoint.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Moderate to severe dry eye disease in both eyes

    • Best-corrected visual acuity (BCVA) of 20/100 or better in each eye

    Exclusion Criteria:

    • Use of any cyclosporine preparations within 3 months

    • Use of topical medications, other than artificial tears, in the eyes within 1 month

    • Use of contact lenses in either eye within 1 month

    • Stage 2 only: Participation in Stage 1 of this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sall Research Medical Center Artesia California United States 90701
    2 Lugene Eye Institute Glendale California United States 91204
    3 Lakeside Vision Center Irvine California United States 92604
    4 Steve Yoelin MD Medical Asscociates Newport Beach California United States 92663
    5 Wolstan & Goldberg Eye Associates Torrance California United States 90505
    6 Vision Institute Colorado Springs Colorado United States 80907
    7 Johns Hopkins University - Wilmer Eye Institute Baltimore Maryland United States 21287
    8 Eye Centers of Racine and Kenosha Kenosha Wisconsin United States 53142

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Eleonora Safyan, Allergan

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT02013791
    Other Study ID Numbers:
    • 192371-024
    First Posted:
    Dec 17, 2013
    Last Update Posted:
    May 15, 2018
    Last Verified:
    Apr 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Eye Diseases
    Cyclosporine
    Cyclosporins

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail This study was terminated. Stage 2 of the study was not conducted.
    Arm/Group Title Stage 1 Cohort 5A Stage 1 Cohort 4 Stage 1 Cohort 6C Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 6B Stage 1 Cohort 6D Stage 1 Cohort 6A Stage 1 Cohort 1
    Arm/Group Description Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
    Period Title: Period 1
    STARTED 8 8 4 8 4 8 4 8 3
    COMPLETED 8 6 4 7 4 8 3 7 3
    NOT COMPLETED 0 2 0 1 0 0 1 1 0
    Period Title: Period 1
    STARTED 0 0 2 0 0 0 3 0 0
    COMPLETED 0 0 2 0 0 0 3 0 0
    NOT COMPLETED 0 0 0 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Stage 1 Cohort 5A Stage 1 Cohort 4 Stage 1 Cohort 6C Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 6B Stage 1 Cohort 6D Stage 1 Cohort 6A Stage 1 Cohort 1 Total
    Arm/Group Description Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. Vehicle administered to study eye and Sham administered to non-study eye on Day 1. Total of all reporting groups
    Overall Participants 8 8 4 8 4 8 4 8 3 55
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.8
    (14.47)
    55.3
    (6.58)
    58.5
    (6.95)
    50.1
    (15.06)
    52.3
    (11.64)
    57.4
    (10.69)
    52.8
    (13.45)
    53.1
    (12.19)
    56.0
    (7.55)
    54.0
    (11.19)
    Age, Customized (Count of Participants)
    <45 years
    2
    25%
    0
    0%
    0
    0%
    2
    25%
    1
    25%
    1
    12.5%
    2
    50%
    2
    25%
    0
    0%
    10
    18.2%
    45 to 65 years
    5
    62.5%
    7
    87.5%
    3
    75%
    5
    62.5%
    2
    50%
    5
    62.5%
    1
    25%
    5
    62.5%
    3
    100%
    36
    65.5%
    >65 years
    1
    12.5%
    1
    12.5%
    1
    25%
    1
    12.5%
    1
    25%
    2
    25%
    1
    25%
    1
    12.5%
    0
    0%
    9
    16.4%
    Sex: Female, Male (Count of Participants)
    Female
    6
    75%
    7
    87.5%
    3
    75%
    5
    62.5%
    3
    75%
    6
    75%
    1
    25%
    7
    87.5%
    2
    66.7%
    40
    72.7%
    Male
    2
    25%
    1
    12.5%
    1
    25%
    3
    37.5%
    1
    25%
    2
    25%
    3
    75%
    1
    12.5%
    1
    33.3%
    15
    27.3%
    Race/Ethnicity, Customized (Count of Participants)
    White
    0
    0%
    1
    12.5%
    2
    50%
    2
    25%
    1
    25%
    2
    25%
    0
    0%
    1
    12.5%
    1
    33.3%
    10
    18.2%
    Black
    1
    12.5%
    0
    0%
    1
    25%
    1
    12.5%
    0
    0%
    1
    12.5%
    0
    0%
    0
    0%
    0
    0%
    4
    7.3%
    Asian
    0
    0%
    1
    12.5%
    0
    0%
    3
    37.5%
    1
    25%
    2
    25%
    1
    25%
    0
    0%
    0
    0%
    8
    14.5%
    Hispanic
    7
    87.5%
    6
    75%
    1
    25%
    2
    25%
    2
    50%
    3
    37.5%
    3
    75%
    7
    87.5%
    2
    66.7%
    33
    60%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
    Description An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
    Time Frame First dose of study drug to up to 24 Weeks

    Outcome Measure Data

    Analysis Population Description
    Safety Population included all participants who received at least one dose of study drug.
    Arm/Group Title Stage 1 Cohort 5A Stage 1 Cohort 4 Stage 1 Cohort 6C Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 6B Stage 1 Cohort 6D Stage 1 Cohort 6A Stage 1 Cohort 1
    Arm/Group Description Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
    Measure Participants 8 8 4 8 4 8 4 8 3
    Count of Participants [Participants]
    7
    87.5%
    8
    100%
    4
    100%
    6
    75%
    4
    100%
    7
    87.5%
    3
    75%
    5
    62.5%
    3
    100%
    2. Other Pre-specified Outcome
    Title Change From Baseline in Corneal Staining Score Using a 6-Point Scale
    Description Total corneal staining with sodium fluorescein was measured in the study eye using the 6-point Oxford scale [Grade 0: <2 dots (best), Grade 1: ≥2 to ≤10 dots, Grade 2: >10 to ≤32 dots, Grade 3: >32 to ≤100 dots, Grade 4: >100 to ≤316 dots and Grade 5: >316 dots or ulcer/erosion (worst)]. The study eye was defined as the eye that received the dosing level of the treatment received. A negative change from Baseline represents a decrease in staining (improvement). Corneal Staining Score was originally registered as a Primary endpoint but it is actually an exploratory endpoint.
    Time Frame Baseline (Day 1) to Week 12

    Outcome Measure Data

    Analysis Population Description
    Modified Intent-to-treat (mITT) Population included all participant who received study treatment and had Baseline and at least 1 post-baseline assessment. Analyses includes participants who had data at both Baseline and Week 12.
    Arm/Group Title Stage 1 Cohort 4
    Arm/Group Description Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
    Measure Participants 6
    Baseline
    2.5
    (0.55)
    Change from Baseline to Week 12
    -0.8
    (1.33)

    Adverse Events

    Time Frame First dose of study drug to up to 24 Weeks
    Adverse Event Reporting Description
    Arm/Group Title Stage 1 Cohort 5A Stage 1 Cohort 4 Stage 1 Cohort 6C Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 6B Stage 1 Cohort 6D Stage 1 Cohort 6A Stage 1 Cohort 1
    Arm/Group Description Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
    All Cause Mortality
    Stage 1 Cohort 5A Stage 1 Cohort 4 Stage 1 Cohort 6C Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 6B Stage 1 Cohort 6D Stage 1 Cohort 6A Stage 1 Cohort 1
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Serious Adverse Events
    Stage 1 Cohort 5A Stage 1 Cohort 4 Stage 1 Cohort 6C Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 6B Stage 1 Cohort 6D Stage 1 Cohort 6A Stage 1 Cohort 1
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal cell carcinoma 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Other (Not Including Serious) Adverse Events
    Stage 1 Cohort 5A Stage 1 Cohort 4 Stage 1 Cohort 6C Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 6B Stage 1 Cohort 6D Stage 1 Cohort 6A Stage 1 Cohort 1
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/8 (87.5%) 8/8 (100%) 4/4 (100%) 6/8 (75%) 4/4 (100%) 7/8 (87.5%) 3/4 (75%) 5/8 (62.5%) 3/3 (100%)
    Eye disorders
    Asthenopia 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Conjunctival haemorrhage 0/8 (0%) 1/8 (12.5%) 1/4 (25%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 2/4 (50%) 1/8 (12.5%) 1/3 (33.3%)
    Conjunctival hyperaemia 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Conjunctival oedema 1/8 (12.5%) 0/8 (0%) 2/4 (50%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 2/4 (50%) 1/8 (12.5%) 0/3 (0%)
    Corneal deposits 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Dry eye 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/3 (0%)
    Eye discharge 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 1/3 (33.3%)
    Eye irritation 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Eye pain 0/8 (0%) 2/8 (25%) 1/4 (25%) 0/8 (0%) 1/4 (25%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Eyelids pruritus 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Foreign body sensation in eyes 3/8 (37.5%) 3/8 (37.5%) 0/4 (0%) 4/8 (50%) 1/4 (25%) 2/8 (25%) 1/4 (25%) 2/8 (25%) 2/3 (66.7%)
    Lacrimation increased 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Meibomian gland discharge 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/3 (0%)
    Ocular discomfort 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Punctate keratitis 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/3 (0%)
    Vision blurred 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    General disorders
    Injection site erythema 4/8 (50%) 5/8 (62.5%) 4/4 (100%) 2/8 (25%) 3/4 (75%) 6/8 (75%) 2/4 (50%) 2/8 (25%) 1/3 (33.3%)
    Injection site pain 1/8 (12.5%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/3 (0%)
    Instillation site pain 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/3 (0%)
    Infections and infestations
    Herpes zoster 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Upper respiratory tract infection 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Injury, poisoning and procedural complications
    Conjunctival abrasion 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/3 (0%)
    Foreign body in eye 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Hand fracture 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Upper limb fracture 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Investigations
    Antinuclear antibody positive 0/8 (0%) 0/8 (0%) 2/4 (50%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Blood urine present 0/8 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Red blood cell count increased 0/8 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)
    Nervous system disorders
    Headache 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/3 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Therapeutic Area Head
    Organization Allergan
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT02013791
    Other Study ID Numbers:
    • 192371-024
    First Posted:
    Dec 17, 2013
    Last Update Posted:
    May 15, 2018
    Last Verified:
    Apr 1, 2018