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

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ClinicalTrials.gov Identifier: NCT02077231
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaodong Zhou, Shanghai Jinshan Hospital

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
Primary Open-angle Glaucoma Drug: Vitamin A Drug: carbomer eye gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Vitamin A

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 Name: 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 Name: Carbomer Eye Drops




Primary Outcome Measures :
  1. change of the density of conjunctival goblet cells [ Time Frame: change from Baseline in goblet cell density at 6 months ]

Secondary Outcome Measures :
  1. tear film parameters changes in patients [ Time Frame: change from baseline in TBUT and Schirmer test at 6 months ]
  2. changes of ocular irritation in patients [ Time Frame: change from baseline in OSDI scores at 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Xiaodong Zhou, Professor of Ophthalmology, Shanghai Jinshan Hospital
ClinicalTrials.gov Identifier: NCT02077231    
Other Study ID Numbers: GlaucomaVitaminA
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents