Meibomian Gland DysfunctionPhase 4NCT00705510
Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction
A Phase 4 study testing 0.05% cyclosporin eye drop in people with Meibomian Gland Dysfunction, run by Mahidol University at 1 site in Thailand.
Trial summary
To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal tear quality and quantity by subjective symptoms and signs including tear breakup time Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- 0.05% cyclosporin eye drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- May 2008to Oct 2010
- Phase
- Phase 4
- 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
- Males or females, of legal age of consent
- Patient has a diagnosis of meibomian gland dysfunction with at least 1 symptom as the following; ocular burning, ocular discomfort, and grittiness
- Had a slit-lamp diagnosis of meibomian gland dysfunction based on the presence of one of the following
- meibomian gland inflammation by lid margin or tarsal erythema, bulbar conjunctiva hyperemia, telangiectasia or thickening irregularity of the eyelid margins
- meibomian gland orifice inclusion (plugging) or abnormal of secretion
- Non-invasive tear break up time (NTBUT) with Tear scope Plus(Keeler, Windsor, UK) ≤ 8 seconds
- Ability to follow study instruction and likely to complete all required visits
Who cannot join
- Age < 18 years old
- Patients with severe ocular disease from Steven Johnson syndrome burn, limbal deficiency
- Patients used cyclosporine within past 1 year
- Patients used oral cyclosporine or anticholinergic drug within past 2 months
- Patients with HIV or autoimmune disease
- Patients with active ocular infections and patients with a history of herpes keratitis
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- Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
- Female patients are pregnant or nursing
- Patients who wear contact lenses
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Ophthalmology; Siriraj Hospital
Bangkok, Bangkok, 10700
About this study
To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal tear quality and quantity by subjective symptoms and signs including tear breakup time
Read the detailed description
Meibomian gland dysfunction patients will divide into 2 groups. One group will have 0.05% cyclosporine opthalmic emulsion and the other will have non-preservative artificial tear twice daily, compare the result in 3 months.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- 0.05% cyclosporin eye drop
- Keywords
- Cyclosporine, Unstable tear film, Meibomian gland, Meibomian gland dysfunction
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% cyclosporin eye dropDrug
Also called Restasis eye drop, Cellufresh eye drop
use the medication twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: 0.05% cyclosporin eye drop |
| B | Placebo comparator | Not described Receives: Drug: 0.05% cyclosporin eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
NTBUT
Measured: 0,1,2,3 month
Secondary outcomes (1)
OSDI score, FTBUT, lid inflammation, meibomian gland secretion and expressibility, bulbar and tarsal conjunctival injection,fluorescein staining, rose bengal staining
Measured: 0,1,2,3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Pinnita Prabhasawat, MD, Principal investigator, Department of Ophthalmology, Siriraj H, Mahidol U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705510
- Sponsor's protocol ID
- 154/2551(EC1)
- Status last verified
- Nov 2010
- First submitted
- 24 Jun 2008
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT00705510
- Acronym / sponsor ID
- 154/2551(EC1)
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Cyclosporine, Unstable tear film, Meibomian gland, Meibomian gland dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Jun 2008 (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 evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal tear quality and quantity by subjective symptoms and signs including tear breakup time
Detailed description
Meibomian gland dysfunction patients will divide into 2 groups. One group will have 0.05% cyclosporine opthalmic emulsion and the other will have non-preservative artificial tear twice daily, compare the result in 3 months.
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 |
|---|---|---|
| A | Active comparator | Drug: 0.05% cyclosporin eye drop |
| B | Placebo comparator | Drug: 0.05% cyclosporin eye drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females, of legal age of consent
- Patient has a diagnosis of meibomian gland dysfunction with at least 1 symptom as the following; ocular burning, ocular discomfort, and grittiness
- Had a slit-lamp diagnosis of meibomian gland dysfunction based on the presence of one of the following
- Non-invasive tear break up time (NTBUT) with Tear scope Plus(Keeler, Windsor, UK) ≤ 8 seconds
- Ability to follow study instruction and likely to complete all required visits
Key exclusion criteria (9 listed)
- Age < 18 years old
- Patients with severe ocular disease from Steven Johnson syndrome burn, limbal deficiency
- Patients used cyclosporine within past 1 year
- Patients used oral cyclosporine or anticholinergic drug within past 2 months
- Patients with HIV or autoimmune disease
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 |
|---|---|---|
| 0.05% cyclosporin eye dropAlso: Restasis eye drop, Cellufresh eye dropuse the medication twice daily for 3 months | Drug | A, B |
Primary outcome
NTBUT
Time frame: 0,1,2,3 month
1 secondary outcome
OSDI score, FTBUT, lid inflammation, meibomian gland secretion and expressibility, bulbar and tarsal conjunctival injection,fluorescein staining, rose bengal staining
Time frame: 0,1,2,3 month
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 9 Nov 2010.
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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.
Pinnita Prabhasawat, MD principal investigator
Department of Ophthalmology, Siriraj H, Mahidol U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.05% cyclosporin eye drop in people with Meibomian Gland Dysfunction, 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 7 inclusion and 9 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 9 Nov 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
NTBUT (time frame: 0,1,2,3 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 9 Nov 2010.