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Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients

Primary Purpose

Primary Open-angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin A
carbomer eye gel
Sponsored by
Xiaodong Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

- diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year.

Exclusion Criteria:

  1. any systemic diseases which may cause ocular damage;
  2. previous ocular trauma or surgery;
  3. contact lens wear history in previous 6 months;
  4. application of any artificial tears 3 months ago;
  5. allergic to any of the drugs we used during examination.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    vitamin A palmitate eye gel

    carbomer eye gel

    Arm Description

    0.1% vitamin A palmitate; Sinqi, Shenyang, China

    0.2% Carbomer 940; Bausch & Lomb, Aschheim, Germany

    Outcomes

    Primary Outcome Measures

    change of the density of conjunctival goblet cells

    Secondary Outcome Measures

    tear film parameters changes in patients
    changes of ocular irritation in patients

    Full Information

    First Posted
    February 23, 2014
    Last Updated
    March 3, 2014
    Sponsor
    Xiaodong Zhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02077231
    Brief Title
    Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Xiaodong Zhou

    4. Oversight

    5. Study Description

    Brief Summary
    Most of the patients under long application of anti-glaucoma eyedrops endure severe ocular surface irritation, which interrupt their quality of life a lot. Lots of studies aimed to search for new drugs for therapy. The investigators hypothesized that the artificial tears containing vitamin A or carbomer may be a great substitute. Both of the two drugs were in common use and had already been tested in animals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Open-angle Glaucoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vitamin A palmitate eye gel
    Arm Type
    Experimental
    Arm Description
    0.1% vitamin A palmitate; Sinqi, Shenyang, China
    Arm Title
    carbomer eye gel
    Arm Type
    Experimental
    Arm Description
    0.2% Carbomer 940; Bausch & Lomb, Aschheim, Germany
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin A
    Other Intervention Name(s)
    vitamin A palmitate eye gel
    Intervention Description
    use one drop in the eye
    Intervention Type
    Drug
    Intervention Name(s)
    carbomer eye gel
    Other Intervention Name(s)
    Carbomer Eye Drops
    Intervention Description
    use one drop in the eye
    Primary Outcome Measure Information:
    Title
    change of the density of conjunctival goblet cells
    Time Frame
    change from Baseline in goblet cell density at 6 months
    Secondary Outcome Measure Information:
    Title
    tear film parameters changes in patients
    Time Frame
    change from baseline in TBUT and Schirmer test at 6 months
    Title
    changes of ocular irritation in patients
    Time Frame
    change from baseline in OSDI scores at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year. Exclusion Criteria: any systemic diseases which may cause ocular damage; previous ocular trauma or surgery; contact lens wear history in previous 6 months; application of any artificial tears 3 months ago; allergic to any of the drugs we used during examination.

    12. IPD Sharing Statement

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