Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

University of Faisalabad

Status: Unknown

Conditions: Dry Eye Disease

Treatments: Drug: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,

Study type: Interventional

Funder types: Other

Identifiers

NCT04970329

TUF/MPO/2102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups, including a placebo group

Systane

Experimental group

Description:

Instill one drop three times a day for one month.

Treatment:

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

Tears Naturale 2

Experimental group

Description:

Instill one drop three times a day for one month.

Treatment:

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

Placebo

Placebo Comparator group

Description:

Instill one drop three times a day for one month.

Treatment:

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