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Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis

Primary Purpose

Allergic Conjunctivitis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PRO-118
Olopatadine Hydrochloride
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provide informed consent
  • Allergic conjunctivitis diagnosis
  • Both genders
  • Age between 6 and 60 years
  • Patients with no treatment 2 years prior to study inclusion

Exclusion Criteria:

  • Patients with one blind eye
  • Visual acuity < 20/40 in any eye
  • Patients with any active ocular disease that would interfere with study interpretation
  • Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
  • Patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer
  • Patients with history of hypersensitivity or contraindication for any drug used in the study
  • Patients receiving systemic or topical treatment based on antihistamines, corticosteroids or immunomodulators
  • Pregnant patients, at risk of pregnancy or breastfeeding
  • Patients without birth control treatment
  • Patients who had participated in any clinical trial in the last 90 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PRO-118

    Olopatadine Hydrochloride

    Arm Description

    pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days

    Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days

    Outcomes

    Primary Outcome Measures

    conjunctival hyperemia
    Change from Baseline in conjunctival hyperemia after 21 days of treatment

    Secondary Outcome Measures

    epiphora
    Change from Baseline in epiphora after 21 days of treatment

    Full Information

    First Posted
    July 19, 2012
    Last Updated
    October 1, 2018
    Sponsor
    Laboratorios Sophia S.A de C.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01657240
    Brief Title
    Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
    Official Title
    Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Formula Reformulation
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    April 2015 (Anticipated)
    Study Completion Date
    May 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Laboratorios Sophia S.A de C.V.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.
    Detailed Description
    Allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances. The main aim in allergic conjunctivitis is to improve the quality of life in these patients. Antihistaminic medication is commonly used to treat allergic conjunctivitis symptoms. The aim of the study is to compare the clinical efficacy of two ophthalmic solutions containing each one an antihistaminic drug. A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. Patients will be randomized to receive one of the treatments for 21 days. Efficacy endpoints will be measured at baseline and at 21 days after treatment.

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PRO-118
    Arm Type
    Experimental
    Arm Description
    pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days
    Arm Title
    Olopatadine Hydrochloride
    Arm Type
    Active Comparator
    Arm Description
    Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days
    Intervention Type
    Drug
    Intervention Name(s)
    PRO-118
    Other Intervention Name(s)
    PRO-118 ophthalmic solution
    Intervention Description
    instill one drop in each eye once a day for 21 days
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine Hydrochloride
    Other Intervention Name(s)
    Olopatadine Hydrochloride ophthalmic solution
    Intervention Description
    instill one drop in each eye once a day for 21 days
    Primary Outcome Measure Information:
    Title
    conjunctival hyperemia
    Description
    Change from Baseline in conjunctival hyperemia after 21 days of treatment
    Time Frame
    day 21
    Secondary Outcome Measure Information:
    Title
    epiphora
    Description
    Change from Baseline in epiphora after 21 days of treatment
    Time Frame
    day 21
    Other Pre-specified Outcome Measures:
    Title
    green lissamine dye
    Description
    Number of patients with normal green lissamine dye
    Time Frame
    day 21
    Title
    fluorescein dye
    Description
    Number of patients with normal fluorescein dye
    Time Frame
    day 21

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provide informed consent Allergic conjunctivitis diagnosis Both genders Age between 6 and 60 years Patients with no treatment 2 years prior to study inclusion Exclusion Criteria: Patients with one blind eye Visual acuity < 20/40 in any eye Patients with any active ocular disease that would interfere with study interpretation Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol Patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer Patients with history of hypersensitivity or contraindication for any drug used in the study Patients receiving systemic or topical treatment based on antihistamines, corticosteroids or immunomodulators Pregnant patients, at risk of pregnancy or breastfeeding Patients without birth control treatment Patients who had participated in any clinical trial in the last 90 days

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis

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