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

NCT ID: NCT03686059

Last Updated: 2019-11-26

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2019-11-20

Brief Summary

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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

Detailed Description

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

Conditions

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Ocular Surface Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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punctal plug

SOFT PLUG® Preloaded Silicone Plugs by OASIS®

Group Type EXPERIMENTAL

punctal plug

Intervention Type DEVICE

punctal plug will be inserted in inferior punctum

Combined

SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)

Group Type EXPERIMENTAL

Omega 3

Intervention Type DRUG

daily intake of 250 mg

punctal plug

Intervention Type DEVICE

punctal plug will be inserted in inferior punctum

control

no medication was given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Omega 3

daily intake of 250 mg

Intervention Type DRUG

punctal plug

punctal plug will be inserted in inferior punctum

Intervention Type DEVICE

Other Intervention Names

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docosahexaenoic acid OASIS SOFT PLUG

Eligibility Criteria

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Inclusion Criteria

* systemic isotretinoin therapy

Exclusion Criteria

* systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Tarek Roshdy mohamed Mahgoub ELhamaky

lecturer of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ACDS

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

Other Identifiers

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hamaky1

Identifier Type: -

Identifier Source: org_study_id

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