NCT03686059

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

September 25, 2018

Last Update Submit

November 24, 2019

Conditions

Ocular Surface Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Break up Time at baseline and during the study

    fluorescein sodium stripes will be used for measurement of Break up Time in seconds

    3 months

Study Arms (3)

punctal plug

EXPERIMENTAL

SOFT PLUG® Preloaded Silicone Plugs by OASIS®

Device: punctal plug

Combined

EXPERIMENTAL

SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)

Drug: Omega 3Device: punctal plug

control

NO INTERVENTION

no medication was given

Interventions

Omega 3DRUG

daily intake of 250 mg

Also known as: docosahexaenoic acid
Combined
punctal plugDEVICE

punctal plug will be inserted in inferior punctum

Also known as: OASIS SOFT PLUG
Combinedpunctal plug

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • systemic isotretinoin therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACDS

Abu Dhabi, 37496, United Arab Emirates

Location

MeSH Terms

Interventions

Docosahexaenoic AcidsPunctal Plugs

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of ophthalmology

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 26, 2018

Study Start

July 2, 2018

Primary Completion

November 15, 2019

Study Completion

November 20, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

AE(1)