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)

June 26, 2019 updated by: Made Susiyanti, Dr Cipto Mangunkusumo General Hospital
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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DM patients with NPDR or PDR
  • Corneal sensitivity less than 45 mm with Cochet Bonnet esthesiometer

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NPDR
Drug: Sodium Hyaluronate, Vitamin A, Vitamin E
Eye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups
ACTIVE_COMPARATOR: NPDR Comparator
Drug: Sodium Hyaluronate, Vitamin A, Vitamin E
Eye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups
EXPERIMENTAL: PDR
Drug: Sodium Hyaluronate, Vitamin A, Vitamin E
Eye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups
ACTIVE_COMPARATOR: PDR Comparator
Drug: Sodium Hyaluronate, Vitamin A, Vitamin E
Eye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks
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.
4 weeks
Conjunctival Goblet Cell Density
Time Frame: 4 weeks
Measurement of conjunctival goblet cell count per mm2. Measured at baseline and day 28.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Cipto Mangunkusumo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (ACTUAL)

June 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-06-0740

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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