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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

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE July 2, 2018
Actual Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03686059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease
Official Title  ICMJE Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ocular Surface Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: punctal plug
    SOFT PLUG® Preloaded Silicone Plugs by OASIS®
    Intervention: Device: punctal plug
  • Experimental: Combined
    SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)
    Interventions:
    • Drug: Omega 3
    • Device: punctal plug
  • No Intervention: control
    no medication was given
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2018)
50
Actual Study Completion Date  ICMJE November 20, 2019
Actual Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • systemic isotretinoin therapy

Exclusion Criteria:

  • systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03686059
Other Study ID Numbers  ICMJE hamaky1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
Study Sponsor  ICMJE Benha University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Benha University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP