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Trial record 93 of 166 for:    ISOTRETINOIN

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

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ClinicalTrials.gov Identifier: NCT03686059
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Tarek Roshdy mohamed Mahgoub ELhamaky, 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


Condition or disease Intervention/treatment Phase
Ocular Surface Disease Drug: Omega 3 Device: punctal plug Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin
Actual Study Start Date : July 2, 2018
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine


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 Name: OASIS SOFT PLUG

Experimental: Combined
SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)
Drug: Omega 3
daily intake of 250 mg
Other Name: docosahexaenoic acid

Device: punctal plug
punctal plug will be inserted in inferior punctum
Other Name: OASIS SOFT PLUG

No Intervention: control
no medication was given



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systemic isotretinoin therapy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686059


Locations
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United Arab Emirates
ACDS
Abu Dhabi, United Arab Emirates, 37496
Sponsors and Collaborators
Benha University

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Responsible Party: Tarek Roshdy mohamed Mahgoub ELhamaky, lecturer of ophthalmology, Benha University
ClinicalTrials.gov Identifier: NCT03686059     History of Changes
Other Study ID Numbers: hamaky1
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No