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

NCT ID: NCT02992535

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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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

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Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Intense pulse light therapy (E-Schwin)

Group Type EXPERIMENTAL

Intense Pulse Light Energy delivery (IPL)

Intervention Type DEVICE

Interventions

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Intense Pulse Light Energy delivery (IPL)

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carones Ophthalmology Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Francesco Carones, MD

Role: CONTACT

Phone: +390276318174

Email: [email protected]

Other Identifiers

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TLEUROPE1

Identifier Type: -

Identifier Source: org_study_id