Ocular Surface DiseasePhase 4NCT03686059
Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease
A Phase 4 study testing Omega 3 and punctal plug in people with Ocular Surface Disease, run by Benha University at 1 site in United Arab Emirates.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- Omega 3 and punctal plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 2 Jul 2018to 20 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- systemic isotretinoin therapy
Who cannot join
- systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin
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
Read the detailed description
Subjective and objective evaluation of ocular surface disease was done at baseline ,1 and 3 months of the study .
- Conditions
- Ocular Surface Disease
- Being tested
- Omega 3, punctal plug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Drug
Also called docosahexaenoic acid
daily intake of 250 mg
punctal plugDevice
Also called OASIS SOFT PLUG
punctal plug will be inserted in inferior punctum
| Study group | Role | What they receive |
|---|---|---|
| punctal plug | Experimental | SOFT PLUG® Preloaded Silicone Plugs by OASIS® Receives: Device: punctal plug |
| Combined | Experimental | SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid) Receives: Drug: Omega 3; Device: punctal plug |
| control | No intervention | no medication was given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start2 Jul 2018
- Primary completion15 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686059
- Sponsor's protocol ID
- hamaky1
- Status last verified
- Nov 2019
- First submitted
- 25 Sep 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin
- ClinicalTrials.gov ID
- NCT03686059
- Acronym / sponsor ID
- hamaky1
- Conditions
- Ocular Surface Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| punctal plug | Experimental | Device: punctal plugSOFT PLUG® Preloaded Silicone Plugs by OASIS® |
| Combined | Experimental | Drug: Omega 3, Device: punctal plugSOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid) |
| control | No intervention | –no medication was given |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- systemic isotretinoin therapy
Key exclusion criteria (1 listed)
- systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3Also: docosahexaenoic aciddaily intake of 250 mg | Drug | Combined |
| punctal plugAlso: OASIS SOFT PLUGpunctal plug will be inserted in inferior punctum | Device | Combined, punctal plug |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Ocular Surface Disease
Not yet recruiting
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Dry Eye Syndrome
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega 3 and punctal plug in people with Ocular Surface Disease, run by Benha University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Break up Time at baseline and during the study (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.