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NCT03686059 Clinical Trial

Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease

Ocular Surface Disease Clinical Trial

Official title:
Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03686059
Other study ID # hamaky1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2, 2018
Est. completion date November 20, 2019

Study information
Verified date November 2019
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ocular surface disease is a common adverse effect of systemic isotretinoin therapy.

The investigators consider that punctal plugs and Omega 3 is a good line for treatment of ocular surface disease associated with systemic isotretinoin therapy

Description:

Subjective and objective evaluation of ocular surface disease was done at baseline ,1 and 3 months of the study .

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date November 20, 2019
Est. primary completion date November 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- systemic isotretinoin therapy

Exclusion Criteria:

- systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Omega 3
daily intake of 250 mg
Device:
• punctal plug
punctal plug will be inserted in inferior punctum

Locations
Country Name City State
United Arab Emirates ACDS Abu Dhabi

Sponsors (1)
Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Break up Time at baseline and during the study fluorescein sodium stripes will be used for measurement of Break up Time in seconds 3 months
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