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

November 24, 2019 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • systemic isotretinoin therapy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: punctal plug
SOFT PLUG® Preloaded Silicone Plugs by OASIS®
Device: punctal plug
punctal plug will be inserted in inferior punctum
Other Names:
  • OASIS SOFT PLUG
EXPERIMENTAL: Combined
SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)
Device: punctal plug
punctal plug will be inserted in inferior punctum
Other Names:
  • OASIS SOFT PLUG
Drug: Omega 3
daily intake of 250 mg
Other Names:
  • docosahexaenoic acid
NO_INTERVENTION: control
no medication was given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Break up Time at baseline and during the study
Time Frame: 3 months
fluorescein sodium stripes will be used for measurement of Break up Time in seconds
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 2, 2018

Primary Completion (ACTUAL)

November 15, 2019

Study Completion (ACTUAL)

November 20, 2019

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (ACTUAL)

September 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 24, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • hamaky1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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