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

March 3, 2014 updated by: Xiaodong Zhou
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of the density of conjunctival goblet cells
Time Frame: change from Baseline in goblet cell density at 6 months
change from Baseline in goblet cell density at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
tear film parameters changes in patients
Time Frame: change from baseline in TBUT and Schirmer test at 6 months
change from baseline in TBUT and Schirmer test at 6 months
changes of ocular irritation in patients
Time Frame: change from baseline in OSDI scores at 6 months
change from baseline in OSDI scores at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaodong Zhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

February 23, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (ESTIMATE)

March 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlaucomaVitaminA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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