Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 93 of 166 for:    ISOTRETINOIN
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 .

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United Arab Emirates
ACDS
Abu Dhabi, United Arab Emirates, 37496
Sponsors and Collaborators
Benha University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No