CClinicalTrials.gg
Status unknownNCT04970329Updated Jul 21, 2021

Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

An interventional study of Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%, in Dry Eye Disease, sponsored by University of Faisalabad. Status unknown at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-21.

Sponsored by University of Faisalabad · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

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In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 96 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

University of Faisalabad is the lead sponsor of 83 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
96 participants (estimated)

Study arms

  • 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%,

  • 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%,

  • 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%,

Interventions

  • DrugPolyethylene 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.

    Also known as: Systane and Tears Naturale 2

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What researchers measure

Primary outcomes

  1. Change in Corneal Thickness in microns

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

    Time frame: one month

  2. 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.

    Time frame: one month

Secondary outcomes

  1. Improvement in dry eye

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

    Time frame: one month

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Study locations

1 site
  • The University of Faisalabad
    Faisalabad, Punjab 3800, Pakistan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04970329
Lead sponsor
University of Faisalabad
Responsible party
Fatima Hussain (principal investigator, University of Faisalabad) — Principal investigator
First posted
Jul 21, 2021
Start date
Jul 2021 (estimated)
Primary completion
Jul 2021 (estimated)
Completion
Aug 2021 (estimated)
Last update
Jul 21, 2021

Study contacts

Komal Atta, mbbs
Contact
komal.atta@tuf.edu.pk
03224075007
Fatima Iqbal, m.phil od
Contact
fatima.iqbal@tuf.edu.pk
03315538865

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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