Clincosm LogoSign in Get a demo

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

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT03686059
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
16.6
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 .

Study Design

Study Type:
Interventional
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 :
Jul 2, 2018
Actual Primary Completion Date :
Nov 15, 2019
Actual Study Completion Date :
Nov 20, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • docosahexaenoic acid

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

    		•
    No Intervention: control

    no medication was given

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • systemic isotretinoin therapy
    Exclusion Criteria:
    • systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ACDS Abu Dhabi United Arab Emirates 37496

    Sponsors and Collaborators

    • Benha University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tarek Roshdy mohamed Mahgoub ELhamaky, lecturer of ophthalmology, Benha University
    ClinicalTrials.gov Identifier:
    NCT03686059
    Other Study ID Numbers:
    • hamaky1
    First Posted:
    Sep 26, 2018
    Last Update Posted:
    Nov 26, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 26, 2019