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

Sponsor
Xiaodong Zhou (Other)
Overall Status
Completed
CT.gov ID
NCT02077231
Collaborator
(none)
30
Enrollment
2
Arms
24
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin A
  • Drug: carbomer eye gel
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: vitamin A palmitate eye gel

0.1% vitamin A palmitate; Sinqi, Shenyang, China

Drug: Vitamin A
use one drop in the eye
Other Names:
  • vitamin A palmitate eye gel

    		•
    Experimental: carbomer eye gel

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

    Drug: carbomer eye gel
    use one drop in the eye
    Other Names:
  • Carbomer Eye Drops

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change of the density of conjunctival goblet cells [change from Baseline in goblet cell density at 6 months]

    Secondary Outcome Measures

    1. tear film parameters changes in patients [change from baseline in TBUT and Schirmer test at 6 months]

    2. changes of ocular irritation in patients [change from baseline in OSDI scores at 6 months]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xiaodong Zhou

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaodong Zhou, Professor of Ophthalmology, Shanghai Jinshan Hospital
    ClinicalTrials.gov Identifier:
    NCT02077231
    Other Study ID Numbers:
    • GlaucomaVitaminA
    First Posted:
    Mar 4, 2014
    Last Update Posted:
    Mar 5, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Vitamins
    Vitamin A
    Retinol palmitate

    Study Results

    No Results Posted as of Mar 5, 2014