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NCT02992535 Clinical Trial

Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity

Dry Eye Clinical Trial

Official title:
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02992535
Other study ID # TLEUROPE1
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received December 2, 2016
Last updated December 21, 2016
Start date January 2017
Est. completion date June 2017

Study information
Verified date December 2016
Source Carones Ophthalmology Center
Contact Francesco Carones, MD
Phone +390276318174
Email fcarones@carones.com
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date June 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Intense Pulse Light Energy delivery (IPL)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Carones Ophthalmology Center

Outcome
Type Measure Description Time frame Safety issue
Primary Tear film osmolarity change 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). No
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