Dry Eye SyndromesPhase 4NCT02595606
0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
A Phase 4 study testing 0.3% Sodium Hyaluronate in people with Dry Eye Syndromes and Diabetes Mellitus, run by Sun Yat-sen University at 1 site in China.
Trial summary
A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium Hyaluronate in the treatment of Dry Eye of diabetic patients. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Dry Eye Syndromes, Diabetes Mellitus
- What is being tested?
- 0.3% Sodium Hyaluronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Mar 2016
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- medical history of diabetes
- diagnosed with proliferative diabetic retinopathy
- diagnosed with dry eye
- not involvement in other drug experiment in the past 2 weeks
- vision acuity better than 0.1
- no local drug using history or with at least 2 weeks blanking period
Who cannot join
- allergy to any of the drug ingredient
- being or going to be pregnant or in lactation period
- with any other eye disease or other serious disease which might affect the trial or could not get in follow-up
- with any eye surgery history in the past six months
- usage of hormone for replacement therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Clinical Research Center
Guangzhou, Guangdong, 510000
Wang Zhichong, M.D., 02087333391, wzc001@hotmail.com
Gao Xinbo, M.D., 02087330484, 936319557@qq.com
About this study
A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium Hyaluronate in the treatment of Dry Eye of diabetic patients.
- Conditions
- Dry Eye Syndromes, Diabetes Mellitus
- Being tested
- 0.3% Sodium Hyaluronate
- Keywords
- dry eye syndromes, diabetes mellitus
- Medical subject headings
- Dry Eye Syndromes, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% Sodium HyaluronateDrug
five times per day for the intervention of eye drop
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | treatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time Receives: Drug: 0.3% Sodium Hyaluronate |
| control group | No intervention | without treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular surface disease index
pre-,1,4,8 weeks after the initiation of the study(the use of drug for experimental group)
Measured: up to 2 months
Secondary outcomes (4)
tear break up time
BUT
Measured: up to 2 months
Schirmer' test
test of tear secretion
Measured: up to 2 months
conjunctival goblet cells density
indirect assessment of tear quality
Measured: up to 2 months
corneal fluorescein staining assessment
assessment of the corneal invasion
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zhichong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595606
- Sponsor's protocol ID
- 03SHDD
- Status last verified
- Jan 2016
- First submitted
- 30 Oct 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Dogru M. Tear secretion and tear film function in insulin dependent diabetics. Br J Ophthalmol. 2000 Oct;84(10):1210. doi: 10.1136/bjo.84.10.1210. No abstract available.
PubMed 11004112Fujishima H, Shimazaki J, Yagi Y, Tsubota K. Improvement of corneal sensation and tear dynamics in diabetic patients by oral aldose reductase inhibitor, ONO-2235: a preliminary study. Cornea. 1996 Jul;15(4):368-75. doi: 10.1097/00003226-199607000-00006.
PubMed 8776562Zhivov A, Stachs O. Re: "Increased Langerhan cell density and corneal nerve damage in diabetic patients: Role of immune mechanisms in human diabetic neuropathy" by Tavakoli et al. Cont Lens Anterior Eye. 2011 Apr;34(2):98; author reply 99. doi: 10.1016/j.clae.2010.12.003. Epub 2011 Jan 6. No abstract available.
PubMed 21215678Maruyama K, Asai J, Ii M, Thorne T, Losordo DW, D'Amore PA. Decreased macrophage number and activation lead to reduced lymphatic vessel formation and contribute to impaired diabetic wound healing. Am J Pathol. 2007 Apr;170(4):1178-91. doi: 10.2353/ajpath.2007.060018.
PubMed 17392158Gao N, Yin J, Yoon GS, Mi QS, Yu FS. Dendritic cell-epithelium interplay is a determinant factor for corneal epithelial wound repair. Am J Pathol. 2011 Nov;179(5):2243-53. doi: 10.1016/j.ajpath.2011.07.050. Epub 2011 Sep 13.
PubMed 21924232Lu W, Ebihara N, Miyazaki K, Murakami A. Reduced expression of laminin-5 in corneal epithelial cells under high glucose condition. Cornea. 2006 Jan;25(1):61-7. doi: 10.1097/01.ico.0000179932.21104.3c.
PubMed 16331044
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
- ClinicalTrials.gov ID
- NCT02595606
- Acronym / sponsor ID
- 03SHDD
- Conditions
- Dry Eye Syndromes, Diabetes Mellitus
- Keywords
- dry eye syndromes, diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 3 Nov 2015 (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.
A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium Hyaluronate in the treatment of Dry Eye of diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: 0.3% Sodium Hyaluronatetreatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time |
| control group | No intervention | –without treatment |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- medical history of diabetes
- diagnosed with proliferative diabetic retinopathy
- diagnosed with dry eye
- not involvement in other drug experiment in the past 2 weeks
- vision acuity better than 0.1
Key exclusion criteria (5 listed)
- allergy to any of the drug ingredient
- being or going to be pregnant or in lactation period
- with any other eye disease or other serious disease which might affect the trial or could not get in follow-up
- with any eye surgery history in the past six months
- usage of hormone for replacement therapy
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 Hyaluronatefive times per day for the intervention of eye drop | Drug | treatment group |
Primary outcome
ocular surface disease index
Time frame: up to 2 months
pre-,1,4,8 weeks after the initiation of the study(the use of drug for experimental group)
4 secondary outcomes
tear break up time
Time frame: up to 2 months
Schirmer' test
Time frame: up to 2 months
conjunctival goblet cells density
Time frame: up to 2 months
corneal fluorescein staining assessment
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Background: PubMed 11004112Dogru M. Tear secretion and tear film function in insulin dependent diabetics. Br J Ophthalmol. 2000 Oct;84(10):1210. doi: 10.1136/bjo.84.10.1210. No abstract available.
- Background: PubMed 8776562Fujishima H, Shimazaki J, Yagi Y, Tsubota K. Improvement of corneal sensation and tear dynamics in diabetic patients by oral aldose reductase inhibitor, ONO-2235: a preliminary study. Cornea. 1996 Jul;15(4):368-75. doi: 10.1097/00003226-199607000-00006.
- Background: PubMed 21215678Zhivov A, Stachs O. Re: "Increased Langerhan cell density and corneal nerve damage in diabetic patients: Role of immune mechanisms in human diabetic neuropathy" by Tavakoli et al. Cont Lens Anterior Eye. 2011 Apr;34(2):98; author reply 99. doi: 10.1016/j.clae.2010.12.003. Epub 2011 Jan 6. No abstract available.
- Background: PubMed 17392158Maruyama K, Asai J, Ii M, Thorne T, Losordo DW, D'Amore PA. Decreased macrophage number and activation lead to reduced lymphatic vessel formation and contribute to impaired diabetic wound healing. Am J Pathol. 2007 Apr;170(4):1178-91. doi: 10.2353/ajpath.2007.060018.
- Background: PubMed 21924232Gao N, Yin J, Yoon GS, Mi QS, Yu FS. Dendritic cell-epithelium interplay is a determinant factor for corneal epithelial wound repair. Am J Pathol. 2011 Nov;179(5):2243-53. doi: 10.1016/j.ajpath.2011.07.050. Epub 2011 Sep 13.
- Background: PubMed 16331044Lu W, Ebihara N, Miyazaki K, Murakami A. Reduced expression of laminin-5 in corneal epithelial cells under high glucose condition. Cornea. 2006 Jan;25(1):61-7. doi: 10.1097/01.ico.0000179932.21104.3c.
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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.
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 0.3% Sodium Hyaluronate in people with Dry Eye Syndromes and Diabetes Mellitus, run by Sun Yat-sen 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 6 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 12 Jan 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Xiulan, M.D. (02087335367, zhangxl2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ocular surface disease index (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595606, which also lists 6 linked publications.
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 12 Jan 2016.