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:
- 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.
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
|
use one drop in the eye
Other Names:
|
|
EXPERIMENTAL: carbomer eye gel
0.2% Carbomer 940; Bausch & Lomb, Aschheim, Germany
|
use one drop in the eye
Other Names:
|
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
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.