An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Sponsor
Sun Pharmaceutical Industries Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02845674
Collaborator
(none)
258
Enrollment
1
Arm
12.6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: OTX-101 0.09%
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
258 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Extension of a Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Actual Study Start Date :
Jul 29, 2016
Actual Primary Completion Date :
Aug 15, 2017
Actual Study Completion Date :
Aug 15, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: OTX-101 0.09%

0.09% cyclosporine nanomicellar solution

Drug: OTX-101 0.09%
0.09% cyclosporine nanomicellar solution
Other Names:
  • Seciera
  • Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [40 weeks]

      Number of subjects reporting any AEs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Completion of Study OTX-101-2016-001
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sun Pharmaceutical Industries Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Pharmaceutical Industries Limited
    ClinicalTrials.gov Identifier:
    NCT02845674
    Other Study ID Numbers:
    • OTX-101-2016-002
    First Posted:
    Jul 27, 2016
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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 DetailGroup 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.
    Arm/Group TitleOTX-101 0.09% to OTX-101 0.09%Vehicle to OTX-101 0.09%
    Arm/Group DescriptionOne drop in each eye BIDOne drop in each eye BID
    Period Title: Overall Study
    STARTED129129
    COMPLETED11179
    NOT COMPLETED1850

    Baseline Characteristics

    Arm/Group TitleGroup 1Group 2Total
    Arm/Group Description0.09% cyclosporine nanomicellar solution OTX-101 0.09%: 0.09% cyclosporine nanomicellar solutionOTX-101 0.09%: 0.09% cyclosporine nanomicellar solutionTotal of all reporting groups
    Overall Participants129129258
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    58.4
    (15.51)
    61.5
    (14.21)
    60.0
    (14.92)
    Sex: Female, Male (Count of Participants)
    Female
    109
    84.5%
    107
    82.9%
    216
    83.7%
    Male
    20
    15.5%
    22
    17.1%
    42
    16.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    18
    14%
    8
    6.2%
    26
    10.1%
    Not Hispanic or Latino
    111
    86%
    121
    93.8%
    232
    89.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.8%
    0
    0%
    1
    0.4%
    Asian
    3
    2.3%
    3
    2.3%
    6
    2.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    0.8%
    1
    0.4%
    Black or African American
    12
    9.3%
    13
    10.1%
    25
    9.7%
    White
    111
    86%
    110
    85.3%
    221
    85.7%
    More than one race
    2
    1.6%
    2
    1.6%
    4
    1.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    TitleAdverse Events
    DescriptionNumber of subjects reporting any AEs
    Time Frame40 weeks

    Outcome Measure Data

    Analysis Population Description
    Safety population: Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.
    Arm/Group TitleGroup 1Group 2
    Arm/Group DescriptionOTX-101 0.09%: 0.09% cyclosporine nanomicellar solutionOTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
    Measure Participants129129
    Number [Count of participants]
    68
    52.7%
    81
    62.8%

    Adverse Events

    Time FrameDay 448
    Adverse Event Reporting Description
    Arm/Group TitleGroup 1Group 2
    Arm/Group DescriptionOTX-101 0.09%: 0.09% cyclosporine nanomicellar solutionOTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
    All Cause Mortality
    Group 1Group 2
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/129 (0%) 0/129 (0%)
    Serious Adverse Events
    Group 1Group 2
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total4/129 (3.1%) 4/129 (3.1%)
    Injury, poisoning and procedural complications
    Wound dehiscence1/129 (0.8%) 0/129 (0%)
    Femur fracture0/129 (0%) 1/129 (0.8%)
    Metabolism and nutrition disorders
    Dehydration1/129 (0.8%) 0/129 (0%)
    Musculoskeletal and connective tissue disorders
    Osteoarthritis2/129 (1.6%) 21/129 (0.8%) 1
    Osteoarthritis0/129 (0%) 1/129 (0.8%) 2
    Nervous system disorders
    Cerebrovascular accident0/129 (0%) 2/129 (1.6%) 2
    Other (Not Including Serious) Adverse Events
    Group 1Group 2
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total55/129 (42.6%) 69/129 (53.5%)
    Cardiac disorders
    Atrial fibrillation2/129 (1.6%) 0/129 (0%)
    Eye disorders
    Conjunctival hyperaemia12/129 (9.3%) 14/129 (10.9%)
    Vitreous detachment5/129 (3.9%) 2/129 (1.6%)
    Posterior capsule opacification5/129 (3.9%) 1/129 (0.8%)
    Blepharitis3/129 (2.3%) 4/129 (3.1%)
    Punctate keratitis12/129 (9.3%) 4/129 (3.1%)
    Eye irritation2/129 (1.6%) 2/129 (1.6%)
    Conjunctival haemorrhage2/129 (1.6%) 2/129 (1.6%)
    Cataract2/129 (1.6%) 0/129 (0%)
    Cataract nuclear2/129 (1.6%) 0/129 (0%)
    Eye allergy2/129 (1.6%) 0/129 (0%)
    Retinal haemorrhage2/129 (1.6%) 0/129 (0%)
    Visual acuity reduced2/129 (1.6%) 0/129 (0%)
    General disorders
    Instillation site reaction1/129 (0.8%) 3/129 (2.3%)
    Instillation site lacrimation1/129 (0.8%) 3/129 (2.3%)
    Instillation site pruritus0/129 (0%) 1/129 (0.8%)
    Instillation site pain17/129 (13.2%) 42/129 (32.6%)
    Investigations
    Intraocular pressure increased2/129 (1.6%) 1/129 (0.8%)

    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/TitleSPARC
    OrganizationSun Pharma Advanced Research Company Limited
    Phone+912266455645
    EmailClinical.Trials@Sparcmail.com
    Responsible Party:
    Sun Pharmaceutical Industries Limited
    ClinicalTrials.gov Identifier:
    NCT02845674
    Other Study ID Numbers:
    • OTX-101-2016-002
    First Posted:
    Jul 27, 2016
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021