Ocular Surface DiseaseNCT01284439
Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% for Ocular Surface Disease in Glaucoma
A study testing hydroxypropylmethylcellulose and sodium hyaluronate in people with Ocular Surface Disease and Glaucoma, run by Mahidol University at 1 site in Thailand.
Trial summary
To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the treatment of ocular surface disease in glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease, Glaucoma
- What is being tested?
- hydroxypropylmethylcellulose and sodium hyaluronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2011to Feb 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OSDI > or equal 20 and eye lid inflammation , meibomian gland inflammation,conjunctival injection,follicle at tarsus , positive corneal staining , tear break up time less than 8 seconds , tear volume less than 5.5 mm.
Who cannot join
- Age below 18 yo
- Active infectious corneal disease
- Post penetrating keratoplasty or glaucoma drainage device
- Known allergy to medication
- Lactation , Pregnant
Trial locations and contacts
1 site in 1 country.
AssocProf Pinnita Tanthuvanit contact
Thailand1 site, 1 recruiting
- Recruiting
Department of Ophthalmology , Siriraj Hospital
Bangkok, Bangkok
Assoc Prof Pinnita Tanthuvanit
About this study
Official title: Effect of Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% in the Treatment of Ocular Surface Disease in Glaucoma Patients
To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the treatment of ocular surface disease in glaucoma patients.
- Conditions
- Ocular Surface Disease, Glaucoma
- Being tested
- hydroxypropylmethylcellulose, sodium hyaluronate
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxypropylmethylcelluloseDrug
TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month
sodium hyaluronateDrug
QID to every 2 hous, 1-2 drops per each time, duration 1 month
| Study group | Role | What they receive |
|---|---|---|
| TearA | Experimental | Not described Receives: Drug: hydroxypropylmethylcellulose |
| TearB | Experimental | Not described Receives: Drug: sodium hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface index score
Measured: 1 month
Secondary outcomes (1)
Eye lid inflammation, corneal staining score, tear break up time and tear volume
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- AssocProf Pinnita Tanthuvanit, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284439
- Sponsor's protocol ID
- 655/2553(EC4)
- Status last verified
- Jan 2011
- First submitted
- 25 Jan 2011
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% in the Treatment of Ocular Surface Disease in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01284439
- Acronym / sponsor ID
- 655/2553(EC4)
- Conditions
- Ocular Surface Disease, Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 27 Jan 2011 (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.
To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the treatment of ocular surface disease in glaucoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TearA | Experimental | Drug: hydroxypropylmethylcellulose |
| TearB | Experimental | Drug: sodium hyaluronate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OSDI > or equal 20 and eye lid inflammation , meibomian gland inflammation,conjunctival injection,follicle at tarsus , positive corneal staining , tear break up time less than 8 seconds , tear volume less than 5.5 mm.
Key exclusion criteria (5 listed)
- Age below 18 yo
- Active infectious corneal disease
- Post penetrating keratoplasty or glaucoma drainage device
- Known allergy to medication
- Lactation , Pregnant
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 |
|---|---|---|
| hydroxypropylmethylcelluloseTearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month | Drug | TearA |
| sodium hyaluronateQID to every 2 hous, 1-2 drops per each time, duration 1 month | Drug | TearB |
Primary outcome
Ocular surface index score
Time frame: 1 month
1 secondary outcome
Eye lid inflammation, corneal staining score, tear break up time and tear volume
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
Related trials for Ocular Surface Disease
Not yet recruiting
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Dry Eye Syndrome
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
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.
AssocProf Pinnita Tanthuvanit contact
AssocProf Pinnita Tanthuvanit, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydroxypropylmethylcellulose and sodium hyaluronate in people with Ocular Surface Disease and Glaucoma, run by Mahidol University at 1 site in Thailand.
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: status not confirmed, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AssocProf Pinnita Tanthuvanit (02-4198036), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular surface index score (time frame: 1 month). 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 27 Jan 2011.