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)

NCT04000789 | Unknown

• 1 other identifier: 19-06-0740
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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. 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)

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  4 weeks

• Conjunctival Goblet Cell Density

  Measurement of conjunctival goblet cell count per mm2. Measured at baseline and day 28.

  4 weeks

Study Arms (4)

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

Interventions

Sodium Hyaluronate, Vitamin A, Vitamin E DRUG

Eye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups

NPDR; NPDR Comparator; PDR; PDR Comparator

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

MeSH Terms

Conditions

Dry Eye Syndromes; Diabetes Mellitus

Interventions

Hyaluronic Acid; Vitamin A; Vitamin E

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Vincent Tahija, MD

CONTACT

+61816896807; Vincent.tahija@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Model Details: 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).

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 27, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share