Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

NCT04970329 | Unknown DMC

• 1 other identifier: TUF/MPO/2102
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Improvement in dry eye

  one month

Study Arms (3)

Systane

EXPERIMENTAL

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%,

Tears Naturale 2

EXPERIMENTAL

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%,

Placebo

PLACEBO COMPARATOR

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%,

Interventions

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

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

Also known as: Systane and Tears Naturale 2

Placebo; Systane; Tears Naturale 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Dry eye has more prevalence in females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ● 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalabad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

polyethylene glycol 400

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Komal Atta, mbbs

CONTACT

03224075007; komal.atta@tuf.edu.pk

Fatima Iqbal, m.phil od

CONTACT

03315538865; fatima.iqbal@tuf.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participant and investigator will be masked about the treatment options.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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)

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 21, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)