Back to resultsEffect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity
Primary Purpose
Dry Eye
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intense Pulse Light Energy delivery (IPL)
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Dry eye
- MGD
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Intense pulse light therapy (E-Schwin)
Outcomes
Primary Outcome Measures
Tear film osmolarity change
Secondary Outcome Measures
Full Information
NCT ID
NCT02992535
First Posted
December 2, 2016
Last Updated
December 21, 2016
Sponsor
Carones Ophthalmology Center
1. Study Identification
Unique Protocol Identification Number
NCT02992535
Brief Title
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity
Official Title
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carones Ophthalmology Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
Intense pulse light therapy (E-Schwin)
Intervention Type
Device
Intervention Name(s)
Intense Pulse Light Energy delivery (IPL)
Primary Outcome Measure Information:
Title
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).
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dry eye
MGD
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Carones, MD
Phone
+390276318174
Email
fcarones@carones.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity
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