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Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Sponsor
University of Faisalabad (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04970329
Collaborator
(none)
96
Enrollment
1
Location
3
Arms
1
Anticipated Duration (Months)
94.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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)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:
Double (Participant, Investigator)
Masking Description:
Both participant and investigator will be masked about the treatment options.
Primary Purpose:
Treatment
Official Title:
Corneal Thickness Changes in Patient Undergoing Dry Eye Managment
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Corneal Thickness in microns [one month]

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

    2. Change in Corneal Thickness in microns after treatment discontinuation. [one month]

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

    Secondary Outcome Measures

    1. Improvement in dry eye [one month]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Faisalabad Faisalabad Punjab Pakistan 3800

    Sponsors and Collaborators

    • University of Faisalabad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatima Hussain, principal investigator, University of Faisalabad
    ClinicalTrials.gov Identifier:
    NCT04970329
    Other Study ID Numbers:
    • TUF/MPO/2102
    First Posted:
    Jul 21, 2021
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Eye Diseases
    Dextrans

    Study Results

    No Results Posted as of Jul 21, 2021