NCT02077231

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

1.4 years

First QC Date

February 23, 2014

Last Update Submit

March 3, 2014

Conditions

Primary Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • change of the density of conjunctival goblet cells

    change from Baseline in goblet cell density at 6 months

Secondary Outcomes (2)

  • tear film parameters changes in patients

    change from baseline in TBUT and Schirmer test at 6 months

  • changes of ocular irritation in patients

    change from baseline in OSDI scores at 6 months

Study Arms (2)

vitamin A palmitate eye gel

EXPERIMENTAL

0.1% vitamin A palmitate; Sinqi, Shenyang, China

Drug: Vitamin A

carbomer eye gel

EXPERIMENTAL

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

Drug: carbomer eye gel

Interventions

Vitamin ADRUG

use one drop in the eye

Also known as: vitamin A palmitate eye gel
vitamin A palmitate eye gel
carbomer eye gelDRUG

use one drop in the eye

Also known as: Carbomer Eye Drops
carbomer eye gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

February 23, 2014

First Posted

March 4, 2014

Study Start

September 1, 2011

Primary Completion

February 1, 2013

Study Completion

September 1, 2013

Last Updated

March 5, 2014

Record last verified: 2014-03