Non-Proliferative Diabetic RetinopathyNCT04000789
The Effect of Combination of Vitamin A, Vitamin E, Sodium Hyaluronate 0.15% Eye Drop Compared With Sodium Hyaluronate 0.1% Eye Drop to Tear Film Stability and Conjunctival Goblet Cells Density in Patient With Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR)
A study testing Sodium Hyaluronate, Vitamin A, Vitamin E in people with Non-Proliferative Diabetic Retinopathy and Proliferative Diabetic Retinopathy New Vessels on Disc, run by Dr Cipto Mangunkusumo General Hospital.
Trial summary
Commonly know that one of the complications caused by Diabetes Mellitus (DM) is microangiopathy. Microangiopathy in the long term may lead to neuropathy of the corneal nerves. Neuropathy of the cornea will lead to dry eyes in DM patient. One of the artificial tears used in treating dry eyes is sodium hyaluronate. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Non-Proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy New Vessels on Disc, Dry Eye Syndromes
- What is being tested?
- Sodium Hyaluronate, Vitamin A, Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Dec 2019
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- DM patients with NPDR or PDR
- Corneal sensitivity less than 45 mm with Cochet Bonnet esthesiometer
Who cannot join
- Patient with anterior chamber inflammation
- Patient with history of ocular surgery (ex. Repair of corneal rupture, cataract surgery, Lasik)
- Patient with history of cerebrovascular event that may affect cognitive function
- Patient had event of disease which may impact corneal sensitivity (ex. Viral keratitis, ophthalmic Herpes Zoster)
- Patient with corneal cicatrix
- Patient on anti-allergic medication
- Pregnant or lactating woman
Trial locations and contacts
No sites are listed yet.
About this study
Commonly know that one of the complications caused by Diabetes Mellitus (DM) is microangiopathy. Microangiopathy in the long term may lead to neuropathy of the corneal nerves. Neuropathy of the cornea will lead to dry eyes in DM patient. One of the artificial tears used in treating dry eyes is sodium hyaluronate. But until recently no research had been done in examining the effect of giving combination of sodium hyaluronate, vitamin A and vitamin E in dry eyes. The antioxidant, and capability of vitamin A and E in promoting cell proliferation may alleviate the symptoms of dry eyes. In this paper we used Ocular Surface Disease Index (OSDI), Tear Break Up time, Schirmer I test and impression cytology to assess baseline and 28 days post therapy in patient with Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR)
Read the detailed description
The study is double blind randomized clinical trial, comparing the usage of combination of sodium hyaluronate 0.15%, vitamin A and vitamin E eye drops compared to sodium hyaluronate 0.1% eye drop only in patient with NPDR or PDR with decreased corneal sensitivity. The examination consisted of OSDI questionnaire, tear film break up time, Schirmer I, and goblet cell density, examined at baseline and 4 weeks (day 28) after the initial eye drops is given. For sample size calculation, estimated 96 patients are required to give statistical effect, this number already calculating the possibility of 20% drop out rate. Every eligible patient is then randomized with block randomization into each allocated arm. Statistical analysis used for this study is unpaired T test if the data distribution is normal, if not Mann-Whitney test will be used.
- Conditions
- Non-Proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy New Vessels on Disc, Dry Eye Syndromes
- Being tested
- Sodium Hyaluronate, Vitamin A, Vitamin E
- Keywords
- Diabetes Mellitus, Proliferative Diabetic Retinopathy, Non-Proliferative Diabetic Retinopathy, Dry Eye Syndromes, Sodium Hyaluronate, Vitamin A, Vitamin E
- 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.
Sodium Hyaluronate, Vitamin A, Vitamin EDrug
Eye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups
| Study group | Role | What they receive |
|---|---|---|
| NPDR | Experimental | Not described Receives: Drug: Sodium Hyaluronate, Vitamin A, Vitamin E |
| NPDR Comparator | Active comparator | Not described Receives: Drug: Sodium Hyaluronate, Vitamin A, Vitamin E |
| PDR | Experimental | Not described Receives: Drug: Sodium Hyaluronate, Vitamin A, Vitamin E |
| PDR Comparator | Active comparator | Not described Receives: Drug: Sodium Hyaluronate, Vitamin A, Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI) questionnaire
A questionnaire to measure subjective symptoms of dry eyes. Possible score of 0 (no dry eye) to 100 (severe dry eye). Measured at baseline, day 14 and day 28.
Measured: 4 weeks
Tear Film Breakup Time
Measurement in seconds of tear film stability. The shorter the fluorescein tear break up time, the lower the tear film stability. Measured at baseline and day 28.
Measured: 4 weeks
Schirmer I Test
Measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Measured at baseline and day 28.
Measured: 4 weeks
Conjunctival Goblet Cell Density
Measurement of conjunctival goblet cell count per mm2. Measured at baseline and day 28.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Proliferative Diabetic RetinopathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study examining DM patient with NPDR or PDR complication with decrease corneal sensitivity. Patient with decreased corneal sensitivity were grouped between NPDR and PDR. NPDR group divided into treatment group (combination of sodium hyaluronate, vitamin A and Vitamin E eye drops given 6 times/day) and control group (Sodium Hyaluronate eye drops only given 6 times/day). Likewise, PDR group divided into treatment group (combination of sodium hyaluronate, vitamin A and Vitamin E eye drops given 6 times/day) and control group (Sodium Hyaluronate eye drops only given 6 times/day).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Made Susiyanti, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000789
- Sponsor's protocol ID
- 19-06-0740
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combination of Vitamin A, Vitamin E, Sodium Hyaluronate 0.15% Eye Drop Compared With Sodium Hyaluronate 0.1% Eye Drop to Tear Film Stability and Conjunctival Goblet Cells Density in Patient With Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR)
- ClinicalTrials.gov ID
- NCT04000789
- Acronym / sponsor ID
- 19-06-0740
- Conditions
- Non-Proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy New Vessels on Disc, Dry Eye Syndromes
- Keywords
- Diabetes Mellitus, Proliferative Diabetic Retinopathy, Non-Proliferative Diabetic Retinopathy, Dry Eye Syndromes, Sodium Hyaluronate, Vitamin A, Vitamin E
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Jun 2019 (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.
Commonly know that one of the complications caused by Diabetes Mellitus (DM) is microangiopathy. Microangiopathy in the long term may lead to neuropathy of the corneal nerves. Neuropathy of the cornea will lead to dry eyes in DM patient. One of the artificial tears used in treating dry eyes is sodium hyaluronate. But until recently no research had been done in examining the effect of giving combination of sodium hyaluronate, vitamin A and vitamin E in dry eyes. The antioxidant, and capability of vitamin A and E in promoting cell proliferation may alleviate the symptoms of dry eyes. In this paper we used Ocular Surface Disease Index (OSDI), Tear Break Up time, Schirmer I test and impression cytology to assess baseline and 28 days post therapy in patient with Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR)
Detailed description
The study is double blind randomized clinical trial, comparing the usage of combination of sodium hyaluronate 0.15%, vitamin A and vitamin E eye drops compared to sodium hyaluronate 0.1% eye drop only in patient with NPDR or PDR with decreased corneal sensitivity. The examination consisted of OSDI questionnaire, tear film break up time, Schirmer I, and goblet cell density, examined at baseline and 4 weeks (day 28) after the initial eye drops is given. For sample size calculation, estimated 96 patients are required to give statistical effect, this number already calculating the possibility of 20% drop out rate. Every eligible patient is then randomized with block randomization into each allocated arm. Statistical analysis used for this study is unpaired T test if the data distribution is normal, if not Mann-Whitney test will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The study examining DM patient with NPDR or PDR complication with decrease corneal sensitivity. Patient with decreased corneal sensitivity were grouped between NPDR and PDR. NPDR group divided into treatment group (combination of sodium hyaluronate, vitamin A and Vitamin E eye drops given 6 times/day) and control group (Sodium Hyaluronate eye drops only given 6 times/day). Likewise, PDR group divided into treatment group (combination of sodium hyaluronate, vitamin A and Vitamin E eye drops given 6 times/day) and control group (Sodium Hyaluronate eye drops only given 6 times/day).
| Arm | Type | Receives |
|---|---|---|
| NPDR | Experimental | Drug: Sodium Hyaluronate, Vitamin A, Vitamin E |
| NPDR Comparator | Active comparator | Drug: Sodium Hyaluronate, Vitamin A, Vitamin E |
| PDR | Experimental | Drug: Sodium Hyaluronate, Vitamin A, Vitamin E |
| PDR Comparator | Active comparator | Drug: Sodium Hyaluronate, Vitamin A, Vitamin E |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- DM patients with NPDR or PDR
- Corneal sensitivity less than 45 mm with Cochet Bonnet esthesiometer
Key exclusion criteria (7 listed)
- Patient with anterior chamber inflammation
- Patient with history of ocular surgery (ex. Repair of corneal rupture, cataract surgery, Lasik)
- Patient with history of cerebrovascular event that may affect cognitive function
- Patient had event of disease which may impact corneal sensitivity (ex. Viral keratitis, ophthalmic Herpes Zoster)
- Patient with corneal cicatrix
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 |
|---|---|---|
| Sodium Hyaluronate, Vitamin A, Vitamin EEye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups | Drug | NPDR, NPDR Comparator, PDR, PDR Comparator |
Primary outcome
Ocular Surface Disease Index (OSDI) questionnaire
Time frame: 4 weeks
A questionnaire to measure subjective symptoms of dry eyes. Possible score of 0 (no dry eye) to 100 (severe dry eye). Measured at baseline, day 14 and day 28.
Tear Film Breakup Time
Time frame: 4 weeks
Measurement in seconds of tear film stability. The shorter the fluorescein tear break up time, the lower the tear film stability. Measured at baseline and day 28.
Schirmer I Test
Time frame: 4 weeks
Measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Measured at baseline and day 28.
Conjunctival Goblet Cell Density
Time frame: 4 weeks
Measurement of conjunctival goblet cell count per mm2. Measured at baseline and day 28.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Hyaluronate, Vitamin A, Vitamin E in people with Non-Proliferative Diabetic Retinopathy and Proliferative Diabetic Retinopathy New Vessels on Disc, run by Dr Cipto Mangunkusumo General 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 2 inclusion and 7 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 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Tahija, MD (+61816896807, Vincent.tahija@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) questionnaire (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 Jun 2019.