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Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Primary Purpose

Dry Eye Disease

Status

Unknown status

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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.

Sites / Locations

The University of Faisalabad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Systane

Tears Naturale 2

Placebo

Arm Description

Instill one drop three times a day for one month.

Outcomes

Primary Outcome Measures

Change in Corneal Thickness in microns

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.

after on month of treatment discontinuation access the change in corneal thickness in microns by using corneal topography.

Secondary Outcome Measures

Improvement in dry eye

after treatment with artifical tears improvement in the tear break-up time in seconds and schirmer test values in millimeters.

Full Information

NCT ID

NCT04970329

First Posted

June 10, 2021

Last Updated

July 9, 2021

Sponsor

University of Faisalabad

1. Study Identification

Unique Protocol Identification Number

NCT04970329

Brief Title

Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Official Title

Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 2021 (Anticipated)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Faisalabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigator

Masking Description

Both participant and investigator will be masked about the treatment options.

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Systane

Arm Type

Experimental

Arm Description

Instill one drop three times a day for one month.

Arm Title

Tears Naturale 2

Arm Type

Experimental

Arm Description

Instill one drop three times a day for one month.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Instill one drop three times a day for one month.

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Systane and Tears Naturale 2

Intervention Description

Drugs will be given to two group and third group will kept on placebo.

Primary Outcome Measure Information:

Title

Change in Corneal Thickness in microns

Description

effect of dry eye treatment on the thickness of the cornea in microns measured by using corneal topography.

Time Frame

one month

Title

Change in Corneal Thickness in microns after treatment discontinuation.

Description

after on month of treatment discontinuation access the change in corneal thickness in microns by using corneal topography.

Time Frame

one month

Secondary Outcome Measure Information:

Title

Improvement in dry eye

Description

after treatment with artifical tears improvement in the tear break-up time in seconds and schirmer test values in millimeters.

Time Frame

one month

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Dry eye has more prevalence in females.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Komal Atta, mbbs

Phone

03224075007

komal.atta@tuf.edu.pk

First Name & Middle Initial & Last Name or Official Title & Degree

Fatima Iqbal, m.phil od

Phone

03315538865

fatima.iqbal@tuf.edu.pk

Facility Information:

Facility Name

The University of Faisalabad

City

Faisalabad

State/Province

Punjab

ZIP/Postal Code

3800

Country

Pakistan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fatima Iqbal, Mphill

Phone

03315538865

fatima.iqbal@tuf.edu.pk

First Name & Middle Initial & Last Name & Degree

Komal Atta, MBBS

Phone

03224075007

komal.atta@tuf.edu.pk

First Name & Middle Initial & Last Name & Degree

Fatima Hussain, Mphill

12. IPD Sharing Statement

Plan to Share IPD

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Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

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