NCT02992535

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

December 2, 2016

Last Update Submit

December 21, 2016

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (1)

Single arm

EXPERIMENTAL

Intense pulse light therapy (E-Schwin)

Device: Intense Pulse Light Energy delivery (IPL)

Interventions

Intense Pulse Light Energy delivery (IPL)DEVICE
Single arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Dry eye
  • MGD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Francesco Carones, MD

CONTACT

+390276318174fcarones@carones.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 14, 2016

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

December 22, 2016

Record last verified: 2016-12