Dry Eye Disease
Conditions
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.
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.
Sponsors
University of Faisalabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both participant and investigator will be masked about the treatment options.
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)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Contacts
Primary ContactKomal Atta, mbbs
Backup ContactFatima Iqbal, m.phil od
Outcome results
None listed