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A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lastacaft ®
Tears Naturale ® (Placebo)
Sponsored by
ORA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
  • Have a positive CAC reaction at Visit 1
  • Have a positive conjunctival inflammation score at Visit 1

Exclusion Criteria:

  • May not use disallowed medications in specified washout period
  • May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
  • May not have active ocular infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Lastacaft ®

    Tears Naturale ®

    Arm Description

    One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2

    One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2

    Outcomes

    Primary Outcome Measures

    Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1
    Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best [least inflammation] and 4 = worst [most inflammation]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.
    Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2
    Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best [least inflammation] and 4 = worst [most inflammation]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.

    Secondary Outcome Measures

    Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)
    CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.
    Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)
    CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.

    Full Information

    First Posted
    December 1, 2014
    Last Updated
    February 24, 2021
    Sponsor
    ORA, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02308501
    Brief Title
    A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ORA, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Conjunctivitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lastacaft ®
    Arm Type
    Active Comparator
    Arm Description
    One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
    Arm Title
    Tears Naturale ®
    Arm Type
    Placebo Comparator
    Arm Description
    One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
    Intervention Type
    Drug
    Intervention Name(s)
    Lastacaft ®
    Intervention Type
    Drug
    Intervention Name(s)
    Tears Naturale ® (Placebo)
    Primary Outcome Measure Information:
    Title
    Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1
    Description
    Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best [least inflammation] and 4 = worst [most inflammation]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.
    Time Frame
    1 hour (+30 minutes) post CAC on Day 1
    Title
    Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2
    Description
    Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best [least inflammation] and 4 = worst [most inflammation]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.
    Time Frame
    1 hour (+30 minutes) post CAC on Day 2
    Secondary Outcome Measure Information:
    Title
    Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)
    Description
    CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.
    Time Frame
    15 minutes post-study medication instillation
    Title
    Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)
    Description
    CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.
    Time Frame
    15 minutes post-study medication instillation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have a positive history of ocular allergies and a positive skin test to protocol defined allergens Have a positive CAC reaction at Visit 1 Have a positive conjunctival inflammation score at Visit 1 Exclusion Criteria: May not use disallowed medications in specified washout period May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters May not have active ocular infection

    12. IPD Sharing Statement

    Learn more about this trial

    A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy

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