Primary Open-angle GlaucomaNCT02077231
Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients
A study testing Vitamin A and carbomer eye gel in people with Primary Open-angle Glaucoma, run by Xiaodong Zhou.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- Vitamin A and carbomer eye gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year.
Who cannot join
- 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.
About this study
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.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- Vitamin A, carbomer eye gel
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
Also called vitamin A palmitate eye gel
use one drop in the eye
carbomer eye gelDrug
Also called Carbomer Eye Drops
use one drop in the eye
| Study group | Role | What they receive |
|---|---|---|
| vitamin A palmitate eye gel | Experimental | 0.1% vitamin A palmitate; Sinqi, Shenyang, China Receives: Drug: Vitamin A |
| carbomer eye gel | Experimental | 0.2% Carbomer 940; Bausch \& Lomb, Aschheim, Germany Receives: Drug: carbomer eye gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the density of conjunctival goblet cells
Measured: change from Baseline in goblet cell density at 6 months
Secondary outcomes (2)
tear film parameters changes in patients
Measured: change from baseline in TBUT and Schirmer test at 6 months
changes of ocular irritation in patients
Measured: change from baseline in OSDI scores at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startSep 2011
- Primary completionFeb 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaodong Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaodong Zhou, Shanghai Jinshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077231
- Sponsor's protocol ID
- GlaucomaVitaminA
- Status last verified
- Mar 2014
- First submitted
- 23 Feb 2014
- Last updated
- 5 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients
- ClinicalTrials.gov ID
- NCT02077231
- Acronym / sponsor ID
- GlaucomaVitaminA
- Conditions
- Primary Open-angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Xiaodong ZhouUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin A palmitate eye gel | Experimental | Drug: Vitamin A0.1% vitamin A palmitate; Sinqi, Shenyang, China |
| carbomer eye gel | Experimental | Drug: carbomer eye gel0.2% Carbomer 940; Bausch \& Lomb, Aschheim, Germany |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin AAlso: vitamin A palmitate eye geluse one drop in the eye | Drug | vitamin A palmitate eye gel |
| carbomer eye gelAlso: Carbomer Eye Dropsuse one drop in the eye | Drug | carbomer eye gel |
Primary outcome
change of the density of conjunctival goblet cells
Time frame: change from Baseline in goblet cell density at 6 months
2 secondary outcomes
tear film parameters changes in patients
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A and carbomer eye gel in people with Primary Open-angle Glaucoma, run by Xiaodong Zhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the density of conjunctival goblet cells (time frame: change from Baseline in goblet cell density at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.