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Pilot Study for Evaluation of LipiFlow Screening Methods


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Chalazion, Dry Eye Syndromes

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Trial Information

Pilot Study for Evaluation of LipiFlow Screening Methods


Inclusion Criteria:



- Meibomian gland dysfunction

- Dry Eye symptoms

Exclusion Criteria:

- Ocular surgery, ocular injury or ocular Herpes infection within past 3 months

- Active ocular infection

- Active ocular inflammation or recurrent inflammation within past 3 months

- Moderate to severe allergic conjunctivitis

- Severe eyelid inflammation

- Eyelid abnormalities that affect lid function

- Ocular surface abnormalities that may compromise corneal integrity

- Systemic disease conditions or medications that cause dry eye

- Use of other treatments for meibomian gland dysfunction or dry eye

- Pregnant or nursing women

- Participation in another ophthalmic clinical trial within past 30 days

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)

Outcome Description:

Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome. Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.

Outcome Time Frame:

Baseline and 4 Weeks

Safety Issue:

No

Principal Investigator

Christy Stevens, OD

Investigator Role:

Study Director

Investigator Affiliation:

TearScience

Authority:

United States: Institutional Review Board

Study ID:

LF002

NCT ID:

NCT01202747

Start Date:

September 2010

Completion Date:

January 2011

Related Keywords:

  • Chalazion
  • Dry Eye Syndromes
  • Chalazion
  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca

Name

Location
Hinsdale, Illinois  60521
Boston, Massachusetts