Dry Eye SyndromeNCT02958514
Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction
A study testing intense pulsed light and Tobramycin and Dexamethasone Ophthalmic Ointment in people with Dry Eye Syndrome, run by Peking University Third Hospital.
Trial summary
This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused by meibomian gland dysfunction and make a comparison between the traditional treatment. Read more about this study
- Who is it for?
- Ages 26 to 78 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- intense pulsed light and Tobramycin and Dexamethasone Ophthalmic Ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 2017
- 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 26 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with dry eye syndrome and diagnosed as MGD
Who cannot join
- an infection or inflammatory disease;
- ocular surgical history with in the last 3 months
- SGOGREN SYNDROME
About this study
This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused by meibomian gland dysfunction and make a comparison between the traditional treatment.
- Conditions
- Dry Eye Syndrome
- Being tested
- intense pulsed light, Tobramycin and Dexamethasone Ophthalmic Ointment
- Keywords
- IPL, MGD
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intense pulsed lightDevice
Intense pulse light (IPL) has been used in dermatology practices for several years as a treatment for rosacea and acne.IPL uses Xenon flashlamp to emit wavelengths of light from 400 to 1200nm. When placed on the light, a filter restricts the wavelength to the visible light range of *500nm.In 2007-2008, an IPL treatment technology-the Diamond Q4 by DermaMed Solutions-was specifically configured to our specifications with the goal of stimulating secretion of normal meibum via skin treatment effects on the meibomian glands. It was discovered that dry eye patients are better positioned for gland expression, as IPL seems to liquefy the abnormal viscous meibum and dilate the glands.
Tobramycin and Dexamethasone Ophthalmic OintmentDrug
| Study group | Role | What they receive |
|---|---|---|
| traditional treatment group | Other | Subjects in this group are treated by tobramycin and dexamethasone ophthalmic ointment qn and artificial tears qid. Receives: Drug: Tobramycin and Dexamethasone Ophthalmic Ointment |
| IPL treatment group | Experimental | Subjects in this group are treated with 3 cycles of intense pulsed light of 4 weeks interval and artificial tears qid. Receives: Device: intense pulsed light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI)
normal value：<13 abnormal value：≥ 13
Measured: through study completion,an average of 6 months
Secondary outcomes (5)
The concentrations of inflammatory cytokines such as IL-1、IL-6 and IL-8
Measured: through study completion,an average of 6 months
breakup time of tear film （BUT）
normal value：>10s abnormal value：≤ 10s
Measured: through study completion,an average of 6 months
Corneal Fluorescein Stain(CFS)
Measured: through study completion,an average of 6 months
Eyelid ester discharge ability score
Measured: through study completion,an average of 6 months
Eyelid ester trait ratings
Measured: through study completion,an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Qi, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958514
- Sponsor's protocol ID
- 2016154
- Status last verified
- May 2022
- First submitted
- 3 Oct 2016
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT02958514
- Acronym / sponsor ID
- 2016154
- Conditions
- Dry Eye Syndrome
- Keywords
- IPL, MGD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Nov 2016 (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.
This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused by meibomian gland dysfunction and make a comparison between the traditional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional treatment group | Other | Drug: Tobramycin and Dexamethasone Ophthalmic OintmentSubjects in this group are treated by tobramycin and dexamethasone ophthalmic ointment qn and artificial tears qid. |
| IPL treatment group | Experimental | Device: intense pulsed lightSubjects in this group are treated with 3 cycles of intense pulsed light of 4 weeks interval and artificial tears qid. |
Who may qualify
- Ages
- 26 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with dry eye syndrome and diagnosed as MGD
Key exclusion criteria (3 listed)
- an infection or inflammatory disease;
- ocular surgical history with in the last 3 months
- SGOGREN SYNDROME
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 |
|---|---|---|
| intense pulsed lightIntense pulse light (IPL) has been used in dermatology practices for several years as a treatment for rosacea and acne.IPL uses Xenon flashlamp to emit wavelengths of light from 400 to 1200nm. When placed on the light, a filter restricts the wavelength to the visible light range of *500nm.In 2007-2008, an IPL treatment technology-the Diamond Q4 by DermaMed Solutions-was specifically configured to our specifications with the goal of stimulating secretion of normal meibum via skin treatment effects on the meibomian glands. It was discovered that dry eye patients are better positioned for gland expression, as IPL seems to liquefy the abnormal viscous meibum and dilate the glands. | Device | IPL treatment group |
| Tobramycin and Dexamethasone Ophthalmic Ointment | Drug | traditional treatment group |
Primary outcome
Ocular Surface Disease Index (OSDI)
Time frame: through study completion,an average of 6 months
normal value：<13 abnormal value：≥ 13
5 secondary outcomes
The concentrations of inflammatory cytokines such as IL-1、IL-6 and IL-8
Time frame: through study completion,an average of 6 months
breakup time of tear film （BUT）
Time frame: through study completion,an average of 6 months
Corneal Fluorescein Stain(CFS)
Time frame: through study completion,an average of 6 months
Eyelid ester discharge ability score
Time frame: through study completion,an average of 6 months
Eyelid ester trait ratings
Time frame: through study completion,an average of 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 May 2022.
- Individual participant dataSharing planned: Yes
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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 intense pulsed light and Tobramycin and Dexamethasone Ophthalmic Ointment in people with Dry Eye Syndrome, run by Peking University Third Hospital.
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 3 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 May 2022. 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?
Ocular Surface Disease Index (OSDI) (time frame: through study completion,an average of 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 May 2022.