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

Phase 4

Completed

• Conditions: Ocular Surface Disease
• Interventions: Device: punctal plug; Drug: Omega 3

• Registration Number: NCT03686059
• Lead Sponsor: Benha University

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 .

Study Timeline

• Study Start: 2018-07-02
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Status Verified: 2019-11
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-20
• Last Update Submitted: 2019-11-24
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• systemic isotretinoin therapy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
punctal plug	punctal plug	SOFT PLUG® Preloaded Silicone Plugs by OASIS®
Combined	Omega 3	SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)
Combined	punctal plug	SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)

Primary Outcome Measures

Name	Time	Method
Change in Break up Time at baseline and during the study	3 months	fluorescein sodium stripes will be used for measurement of Break up Time in seconds

Trial Locations

Locations (1)

ACDS; 🇦🇪 Abu Dhabi, United Arab Emirates