Dry EyePhase 3NCT03515187
Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops
A Phase 3 study testing 0.3% sodium hyaluronate ophthalmic solution, 0.1% sodium bromide solution and Meibomian gland massage in people with Dry Eye and MGD-Meibomian Gland Dysfunction, run by Shenzhen Hospital of Southern Medical University at 1 site in China.
Trial summary
A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, MGD-Meibomian Gland Dysfunction
- What is being tested?
- 0.3% sodium hyaluronate ophthalmic solution, 0.1% sodium bromide solution and Meibomian gland massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jun 2018to Oct 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma or primary angle closure glaucoma, require treatment with anti-glaucoma eye drops.
- A group: Patients using glaucoma eye drops longer than 6 months, and in accordance with the diagnostic criteria of dry eye:
- Subjective symptoms (required): dryness, foreign body sensation, fatigue and discomfort;
- The instability of tear film (required): tear break up time (TBUT);
- Lacrimal secretion: Schirmer I test;
- The ocular surface damage (strengthen diagnosis): fluorescein staining (FL); in the mentioned in ①+②（TBUT≤5s) or ①+②（TBUT≤10s)+③（<10mm）/④（FL+）。
- The choice of study eyes: Choose the eye of the patient with low basical intraocular pressure, and if the basal intraocular pressure is the same, choose the right eye for the study.
- Voluntary participation in this clinical study, and signed informed consent.
Who cannot join
- With metabolic diseases, autoimmune diseases, connective tissue diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Sjogren's syndrome eat;
- Combined with cerebrovascular, liver, kidney, hematopoietic serious system desease, atumor diseases and psychosis.
- Using any artificial tears and except any clinical trials of dry eyes within two weeks.
- With drug therapy, embolization and surgical treatment of dry eyes.
- With other eye diseases, such as eyelid defects, hypophasis, pterygium, chronic dacryocystitis, trichiasis, corneal lesions.
Trial locations and contacts
1 site in 1 country.
China1 site
Yingli Li
Shenzhen, Guangdong, 518110
Li Yingli, +81-181-2478-3057, liyingli333@qq.com
About this study
Official title: A Multicenter Randomized Controlled Trial on Prevention and Treatment of Ocular Surface Injury and Meibomian Gland Dysfunction in Patients Using Anti-Glaucoma Eye Drops
A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.
Read the detailed description
- To compare the efficacy of drug therapy (sodium hyaluronate + sodium bromide) and combined therapy (combined with meibomian gland massage based on drug therapy) on drug-induced dry eye caused by long-term use of anti glaucoma drugs; 2. To evaluate the efficacy of sodium hyaluronate in the prevention of ocular surface and meibomian gland dysfunction and structural damage in the early stage of patients using anti glaucoma eye drops.
- Conditions
- Dry Eye, MGD-Meibomian Gland Dysfunction
- Being tested
- 0.3% sodium hyaluronate ophthalmic solution, 0.1% sodium bromide solution, Meibomian gland massage, Placebo
- Keywords
- Dug induced dry eye, meibomian gland dysfunction, MGD, Sodium hyaluronate ophthalmic solution, Sodium bromide hydrate eye drops, Meibomian gland massage
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% sodium hyaluronate ophthalmic solutionDrug
one to two drops in eye, four times per day
0.1% sodium bromide solutionDrug
one to two drops in eye, twice per day
Meibomian gland massageOther
Physiotherapy
PlaceboOther
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| A1 Medicine treatment group | Experimental | 0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days Receives: Drug: 0.3% sodium hyaluronate ophthalmic solution; Drug: 0.1% sodium bromide solution |
| A2 Combined treatment group | Experimental | 0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days Receives: Drug: 0.3% sodium hyaluronate ophthalmic solution; Drug: 0.1% sodium bromide solution; Other: Meibomian gland massage |
| B1 Control group | Placebo comparator | Placebo Receives: Other: Placebo |
| B2 Experiment group | Experimental | 0.3%sodium hyaluronate ophthalmic solution, 12 months Receives: Drug: 0.3% sodium hyaluronate ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Ocular Surface Disease Index (OSDI) score
Primary indicator
Measured: At screening, 1 month and 2 months for treatment.
Secondary outcomes (3)
Change from baseline in Tear break up time (TBUT)
Secondary indicator
Measured: At screening, 1 month and 2 months for treatment.
Change from baseline in corneal staining scores
Secondary indicator
Measured: At screening, 1 month and 2 months for treatment.
Change from baseline in schirmer test
Secondary indicator
Measured: At screening, 1 month and 2 months for treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study startJun 2018 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hospital of Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingli Li, Shenzhen Hospital of Southern Medical University
- Investigators
- Yingli Li, Study chair, Shenzhen Hospital of Southern Medicine UniversityMin Fu, Principal investigator, Zhejiang HospitalLang Bai, Principal investigator, Nanfang Hospital, Southern Medical UniversityGuanghua Zhou, Principal investigator, The Fifth Affiliated Hospital of Southern Medical UniversityLei Xi, Principal investigator, Guangdong Provincial People's HospitalXiaolin Zhao, Principal investigator, Shenzhen Hospital of Southern Medicine UniversityWanli Liu, Principal investigator, Shenzhen Hospital of Southern Medicine UniversityYan Wang, Principal investigator, Shenzhen Hospital of Southern Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515187
- Sponsor's protocol ID
- LC2016YM017
- Status last verified
- Apr 2018
- First submitted
- 13 May 2017
- Last updated
- 3 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If we decided to share the individual participants data (IPD), the IPD will be shared with in six months after the clinical trial by loading ResMan(the web-based medical research public management platform- Research manager, ResMan).
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial on Prevention and Treatment of Ocular Surface Injury and Meibomian Gland Dysfunction in Patients Using Anti-Glaucoma Eye Drops
- ClinicalTrials.gov ID
- NCT03515187
- Acronym / sponsor ID
- LC2016YM017
- Conditions
- Dry Eye, MGD-Meibomian Gland Dysfunction
- Keywords
- Dug induced dry eye, meibomian gland dysfunction, MGD, Sodium hyaluronate ophthalmic solution, Sodium bromide hydrate eye drops, Meibomian gland massage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shenzhen Hospital of Southern Medical UniversityUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 3 May 2018 (actual)
- 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.
A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.
Detailed description
- To compare the efficacy of drug therapy (sodium hyaluronate + sodium bromide) and combined therapy (combined with meibomian gland massage based on drug therapy) on drug-induced dry eye caused by long-term use of anti glaucoma drugs; 2. To evaluate the efficacy of sodium hyaluronate in the prevention of ocular surface and meibomian gland dysfunction and structural damage in the early stage of patients using anti glaucoma eye drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 Medicine treatment group | Experimental | Drug: 0.3% sodium hyaluronate ophthalmic solution, Drug: 0.1% sodium bromide solution0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days |
| A2 Combined treatment group | Experimental | Drug: 0.3% sodium hyaluronate ophthalmic solution, Drug: 0.1% sodium bromide solution, Other: Meibomian gland massage0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days |
| B1 Control group | Placebo comparator | Other: PlaceboPlacebo |
| B2 Experiment group | Experimental | Drug: 0.3% sodium hyaluronate ophthalmic solution0.3%sodium hyaluronate ophthalmic solution, 12 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma or primary angle closure glaucoma, require treatment with anti-glaucoma eye drops.
- A group: Patients using glaucoma eye drops longer than 6 months, and in accordance with the diagnostic criteria of dry eye:
- The choice of study eyes: Choose the eye of the patient with low basical intraocular pressure, and if the basal intraocular pressure is the same, choose the right eye for the study.
- Voluntary participation in this clinical study, and signed informed consent.
Key exclusion criteria (5 listed)
- With metabolic diseases, autoimmune diseases, connective tissue diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Sjogren's syndrome eat;
- Combined with cerebrovascular, liver, kidney, hematopoietic serious system desease, atumor diseases and psychosis.
- Using any artificial tears and except any clinical trials of dry eyes within two weeks.
- With drug therapy, embolization and surgical treatment of dry eyes.
- With other eye diseases, such as eyelid defects, hypophasis, pterygium, chronic dacryocystitis, trichiasis, corneal lesions.
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 |
|---|---|---|
| 0.3% sodium hyaluronate ophthalmic solutionone to two drops in eye, four times per day | Drug | A1 Medicine treatment group, A2 Combined treatment group, B2 Experiment group |
| 0.1% sodium bromide solutionone to two drops in eye, twice per day | Drug | A1 Medicine treatment group, A2 Combined treatment group |
| Meibomian gland massagePhysiotherapy | Other | A2 Combined treatment group |
| PlaceboVehicle | Other | B1 Control group |
Primary outcome
Change from baseline in Ocular Surface Disease Index (OSDI) score
Time frame: At screening, 1 month and 2 months for treatment.
Primary indicator
3 secondary outcomes
Change from baseline in Tear break up time (TBUT)
Time frame: At screening, 1 month and 2 months for treatment.
Change from baseline in corneal staining scores
Time frame: At screening, 1 month and 2 months for treatment.
Change from baseline in schirmer test
Time frame: At screening, 1 month and 2 months for treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: Undecided. If we decided to share the individual participants data (IPD), the IPD will be shared with in six months after the clinical trial by loading ResMan(the web-based medical research public management platform- Research manager, ResMan).
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Yingli Li study chair
Shenzhen Hospital of Southern Medicine University
Min Fu principal investigator
Zhejiang Hospital
Lang Bai principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.3% sodium hyaluronate ophthalmic solution, 0.1% sodium bromide solution and Meibomian gland massage in people with Dry Eye and MGD-Meibomian Gland Dysfunction, run by Shenzhen Hospital of Southern Medical University at 1 site in China.
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 8 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 3 May 2018. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yingli Li (+81-18124783057, liyingli333@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Ocular Surface Disease Index (OSDI) score (time frame: At screening, 1 month and 2 months for treatment.). 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 3 May 2018.