Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Not Applicable

• Conditions: Dry Eye Disease
• Interventions: Drug: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,

• Registration Number: NCT04970329
• Lead Sponsor: University of Faisalabad

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.

Study Timeline

• Study First Submitted: 2021-06-10
• Status Verified: 2021-07
• Study Start: 2021-07
• Primary Completion: 2021-07
• Study First Submitted QC: 2021-07-09
• Last Update Submitted: 2021-07-09
• Study First Posted: 2021-07-21
• Last Update Posted: 2021-07-21
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systane	Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,	Instill one drop three times a day for one month.
Placebo	Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,	Instill one drop three times a day for one month.
Tears Naturale 2	Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,	Instill one drop three times a day for one month.

Primary Outcome Measures

Name	Time	Method
Change in Corneal Thickness in microns	one month	effect of dry eye treatment on the thickness of the cornea in microns measured by using corneal topography.
Change in Corneal Thickness in microns after treatment discontinuation.	one month	after on month of treatment discontinuation access the change in corneal thickness in microns by using corneal topography.

Secondary Outcome Measures

Name	Time	Method
Improvement in dry eye	one month	after treatment with artifical tears improvement in the tear break-up time in seconds and schirmer test values in millimeters.

Trial Locations

Locations (1)

The University of Faisalabad; 🇵🇰 Faisalabad, Punjab, Pakistan