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Objective Evaluation of Ocular Surface Lubricants in Two Environments

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University of Rochester

Status and phase

Completed
Early Phase 1

Conditions

Dry Eye

Treatments

Drug: Liposic EDO
Drug: B & L Soothe Lubricant Eye Drops
Drug: OcuFresh Eye Wash

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.

Full description

This study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. The investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control).

The investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. Subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.

Enrollment

20 patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 30-75 years
  • Good general health
  • Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits
  • Currently using an OTC artificial tear for ocular comfort, at least occasionally.
  • At least one positive dry eye symptom.

Exclusion criteria

  • Current eye disease, infection or inflammation that requires the use of any prescription ocular medication.
  • Recent past eye surgery.
  • Female subjects may not be pregnant or lactating.
  • Infectious diseases

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 1 patient group

Drop Administration
Experimental group
Treatment:
Drug: Liposic EDO
Drug: OcuFresh Eye Wash
Drug: B & L Soothe Lubricant Eye Drops

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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