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

Primary Open-angle Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077231
• Other study ID #: GlaucomaVitaminA
• Status: Completed
• Phase: N/A
• First received: February 23, 2014
• Last updated: March 3, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Shanghai Jinshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Drug:
• Vitamin A
use one drop in the eye
• carbomer eye gel
use one drop in the eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiaodong Zhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of the density of conjunctival goblet cells		change from Baseline in goblet cell density at 6 months	Yes
Secondary	tear film parameters changes in patients		change from baseline in TBUT and Schirmer test at 6 months	Yes
Secondary	changes of ocular irritation in patients		change from baseline in OSDI scores at 6 months	Yes