Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Dry Eye Disease Clinical Trial

Official title:

Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04970329
• Other study ID #: TUF/MPO/2102
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: August 2021

Study information

• Verified date: July 2021
• Source: University of Faisalabad
• Contact: Komal Atta, mbbs
• Phone: 03224075007
• Email: komal.atta[@]tuf.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: August 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,
Drugs will be given to two group and third group will kept on placebo.

Locations

Country	Name	City	State
Pakistan	The University of Faisalabad	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Faisalabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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