Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,

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 Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Komal Atta, MBBS; Phone Number: 03224075007; Email: komal.atta@tuf.edu.pk
• Study Contact Backup: Name: Fatima Iqbal, m.phil od; Phone Number: 03315538865; Email: fatima.iqbal@tuf.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Faisalabad, Punjab, Pakistan, 3800
      • The University of Faisalabad
      • Contact: Komal Atta, MBBS; Phone Number: 03224075007; Email: komal.atta@tuf.edu.pk
      • Contact: Fatima Iqbal, Mphill; Phone Number: 03315538865; Email: fatima.iqbal@tuf.edu.pk
      • Principal Investigator: Fatima Hussain, Mphill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Systane; 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%,; Drugs will be given to two group and third group will kept on placebo.; Other Names: Systane and Tears Naturale 2
Experimental: Tears Naturale 2; 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%,; Drugs will be given to two group and third group will kept on placebo.; Other Names: Systane and Tears Naturale 2
Placebo Comparator: Placebo; 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%,; Drugs will be given to two group and third group will kept on placebo.; 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

Collaborators and Investigators

• Sponsor: University of Faisalabad

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Anticoagulants; Plasma Substitutes; Blood Substitutes; Dextrans
• Other Study ID Numbers: TUF/MPO/2102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No