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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane | Experimental | Instill one drop three times a day for one month. |
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| Tears Naturale 2 | Experimental | Instill one drop three times a day for one month. |
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| Placebo | Placebo Comparator | Instill one drop three times a day for one month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in dry eye | after treatment with artifical tears improvement in the tear break-up time in seconds and schirmer test values in millimeters. | one month |
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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:
Dry eye has more prevalence in females.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Komal Atta, mbbs | Contact | 03224075007 | komal.atta@tuf.edu.pk | |
| Fatima Iqbal, m.phil od | Contact | 03315538865 | fatima.iqbal@tuf.edu.pk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Faisalabad | Faisalabad | Punjab Province | 3800 | Pakistan |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000595213 | polyethylene glycol 400 |
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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)
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Both participant and investigator will be masked about the treatment options.
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