Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

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Systane

Instill one drop three times a day for one month.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Tears Naturale 2

Instill one drop three times a day for one month.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Placebo

Instill one drop three times a day for one month.

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Systane and Tears Naturale 2

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes