Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level

Study Overview
=================
Brief Summary
-----------------
Dry eye disease is multifactorial, ocular inflammatory condition causing irritation, stinging sensation, uneasiness and blurring. Non-Sjogren syndrome occurs due to absent or dysfunction of lacrimal gland. Fat soluble vitamin D act as an agent against inflammation and its deficiency may result in various inflammatory diseases including dry eye. Purpose of this study is evaluation of vitamin D3 supplementation role in treating non-Sjogren dry eye along with conventional treatment by using artificial tears in patients with hypovitaminosis D. A prospective study was conducted in Rural health center(RHC) Buchal Kalan on 108 patients presenting with non-Sjogren dry eyes and low serum vitamin D levels. Patients were subjected to the following examination; best corrected visual acuity (BCVA), slit-lamp examination, applanation tonometry, fundoscopy, tear breakup time (TBUT) after fluorescein staining, Schirmer tear test, numerical pain rating scale (NPRS) and ocular surface disease index (OSDI) score on day 0, 15, 30, 60 and 90. Vitamin D levels was assessed by electrochemiluminescence immunoassay (ECLIA) based analyzer. The sample was randomly divided into two groups by non-probability purposive sampling. Group 1 received only artificial tears 4times/day while group 2 were given oral vitamin D3 supplementation of 6000 international unit (IU) daily along with artificial tears. Impact of oral vitamin D3 supplementation on non-Sjogren dry eyes was assessed by comparing means of ocular parameters of both groups over different period of time by using Mann-Whitney Test and Friedman Test.

Official Title
-----------------
Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level

Conditions
-----------------
Dry Eye Syndromes, Hypovitaminosis D

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Artificial tear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with non-Sjogren dry eyes with low serum vitamin D level. Both gender. Age group will be 20-50 years of age. Cooperative patients. Exclusion Criteria: Autoimmune diseases (such as Sjogren syndrome and lupus syndrome). All ocular pathologies except dry eyes. All systemic pathologies that affects tear layers. All non- cooperative patients.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Treatment<br>Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days. | Drug: Artificial tear<br>* Conventional dry eye treatment<br>|
| Experimental: Vitamin D3 Supplementation<br>Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days. | Drug: Vitamin D<br>* New treatment option for dry eye patients with low serum vitamin D Level<br>Drug: Artificial tear<br>* Conventional dry eye treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Breakup time in seconds | Improvement after vitamin D3 supplementation over a period of time | 90 days | 
| Schirmer test score in millimeters | Improvement after vitamin D3 supplementation over a period of time | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface disease index score in units | Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition. | 90 days | 
| Numerical Pain Rating Scale | Change in both groups after treatment. Values ranges from 0 to 10 wher 0 indicates no pain while 10 indicates worst pain | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial tears., Dry eye syndrome., vitamin d deficiency.