Diagnostic Evaluation of the Tear Film

TearScience

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: Tear Film Analyzer

Study type: Observational

Funder types: Industry

Identifiers

NCT00761917

KS010

Details and patient eligibility

About

The objectives of this study are to assess for a difference between normal and dry eye subjects in tear film quality using a diagnostic interferometry device and to determine whether there are associations between tear film quality and dry eye symptoms and signs.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 18 year of age or older
• Willing and able to comply with study exam procedure

Exclusion criteria

• Eyelid abnormality or ocular surface condition affecting ability to visualize tear film

• Women who are pregnant or nursing

• Any of the following conditions within specified timeframe prior to study participation:

  1. Instillation of eye drops
  2. Contact lens wear
  3. Use of oil-based facial cosmetics
  4. Swimming in chlorinated pool
  5. Eye examination procedures that may affect the tear film
  6. Participation in another ophthalmic clinical trial

Trial design

229 participants in 2 patient groups

1: Normal

Description:

Subjects without dry eye symptoms based on questionnaire.

Treatment:

Device: Tear Film Analyzer

2: Dry Eye

Description:

Subjects with dry eye symptoms based on questionnaire.

Treatment:

Device: Tear Film Analyzer