Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface... | NCT03686059

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

NCT03686059

Sponsor

Benha University

Status

Completed

Last Update Posted

Nov 26, 2019Actual

Enrollment

90Actual

Phase

Phase 4

Conditions

Ocular Surface Disease

Interventions

Omega 3
punctal plug

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2018Actual

Primary Completion Date

Nov 15, 2019Actual

Completion Date

Nov 20, 2019Actual

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2019

Last Update Posted Date

Nov 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarek Roshdy mohamed Mahgoub ELhamaky, lecturer of ophthalmology, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
punctal plug	Experimental	SOFT PLUG® Preloaded Silicone Plugs by OASIS®	Device: punctal plug
Combined	Experimental	SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)	Drug: Omega 3 Device: punctal plug
control	No Intervention	no medication was given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega 3	Drug	daily intake of 250 mg	Combined	docosahexaenoic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

systemic isotretinoin therapy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ACDS		Abu Dhabi		37496	United Arab Emirates

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004281	Docosahexaenoic Acids
D000070635	Punctal Plugs

Ancestor Terms

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats

Browse Leaves

Not provided

Browse Branches

Not provided