Dry EyePhase 4NCT02992535
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity
A Phase 4 study testing Intense Pulse Light Energy delivery (IPL) in people with Dry Eye, run by Carones Ophthalmology Center.
Trial summary
Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye
- What is being tested?
- Intense Pulse Light Energy delivery (IPL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dry eye
- MGD
Who cannot join
- No history of ocular infection or corneal degeneration/dystrophy
- No history of corneal refractive surgery
- No change in ocular medications in the last 2 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).
Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.
Read the detailed description
Prospective study design among subjects with MGD and qualifying for IPL therapy.
Study testing done at baseline visit when subjects are scheduled for IPL therapy. Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
Subjects willing to come for follow up visits as scheduled and may not have instilled any artificial tears 2 hours prior to study measurements.
No history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery and/or change in ocular medications in the last 2 months
- Conditions
- Dry Eye
- Being tested
- Intense Pulse Light Energy delivery (IPL)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense Pulse Light Energy delivery (IPL)Device
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Intense pulse light therapy (E-Schwin) Receives: Device: Intense Pulse Light Energy delivery (IPL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film osmolarity change
Measured: Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carones Ophthalmology Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992535
- Sponsor's protocol ID
- TLEUROPE1
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).
- ClinicalTrials.gov ID
- NCT02992535
- Acronym / sponsor ID
- TLEUROPE1
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Carones Ophthalmology CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- 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.
Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.
Detailed description
Prospective study design among subjects with MGD and qualifying for IPL therapy.
Study testing done at baseline visit when subjects are scheduled for IPL therapy. Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
Subjects willing to come for follow up visits as scheduled and may not have instilled any artificial tears 2 hours prior to study measurements.
No history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery and/or change in ocular medications in the last 2 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Intense Pulse Light Energy delivery (IPL)Intense pulse light therapy (E-Schwin) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Dry eye
- MGD
Key exclusion criteria (3 listed)
- No history of ocular infection or corneal degeneration/dystrophy
- No history of corneal refractive surgery
- No change in ocular medications in the last 2 months
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 |
|---|---|---|
| Intense Pulse Light Energy delivery (IPL) | Device | Single arm |
Primary outcome
Tear film osmolarity change
Time frame: Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intense Pulse Light Energy delivery (IPL) in people with Dry Eye, run by Carones Ophthalmology Center.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Carones, MD (+390276318174, fcarones@carones.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film osmolarity change (time frame: Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).). 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 22 Dec 2016.