Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to the determine effect of dry eye and to compare the effect of artificial tears on central and peripheral corneal thickness.

Detailed Description
-----------------
In this randomized controlled trial, 96 eyes of females with dry eye will be recruited through random sampling. Dry eye assessments will be done including TBUT, Schirmer test 1, and OSDI questionnaire. 96 eyes will be divided into 3 groups (32 eyes each) and will be provided intervention which is Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. , Dextran 0.1%Hypromellose 0.3%, and placebo(normal saline) through randomization by an unmasked investigator. Changes in central and peripheral corneal thickness will be evaluated by corneal topography. Patients will be evaluated at baseline, after 15 days, after 1 month, and re-evaluated after 1 month of cessation of treatment.

Official Title
-----------------
Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ● Females with ages ranging between 18-40 years and OSDI scores greater than 13, ametropia of up to 1DS of SE with astigmatism of less than 0.5DC, and Emmetropes. Exclusion Criteria: Refractive error of more than ±1 Ds of SE and astigmatism of greater than ±0.5DC. Corneal surface disease other than dry eye disease. Corneal ectasia. Corneal or eyelid infections Age < 18 and >40 years. History of contact lens wears within the past three months. Male will be excluded because sex has a large influence on the symptomatology of DED Males have significantly low symptom scores as compared to females. Corneal surgeries. History of ocular /systemic disease within the past 6 months. The patients already receiving any kind of treatment for DED and other ocular diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 96 eyes will be divided into 3 groups (32 eyes each) and will be provided intervention which is Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. , Dextran 0.1%Hypromellose 0.3%, and placebo(normal saline)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane<br>Instill one drop three times a day for one month. | Drug: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,<br>* Drugs will be given to two group and third group will kept on placebo.<br>* Other names: Systane and Tears Naturale 2;|
| Experimental: Tears Naturale 2<br>Instill one drop three times a day for one month. | Drug: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,<br>* Drugs will be given to two group and third group will kept on placebo.<br>* Other names: Systane and Tears Naturale 2;|
| Placebo Comparator: Placebo<br>Instill one drop three times a day for one month. | Drug: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,<br>* Drugs will be given to two group and third group will kept on placebo.<br>* Other names: Systane and Tears Naturale 2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Corneal Thickness in microns | effect of dry eye treatment on the thickness of the cornea in microns measured by using corneal topography. | one month | 
| Change in Corneal Thickness in microns after treatment discontinuation. | after on month of treatment discontinuation access the change in corneal thickness in microns by using corneal topography. | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in dry eye | after treatment with artifical tears improvement in the tear break-up time in seconds and schirmer test values in millimeters. | one month |