Objective Evaluation of Ocular Surface Lubricants in Two Environments

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
James V. Aquavella, MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01375582
First received: June 14, 2011
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Dry Eye
Drug: B & L Soothe Lubricant Eye Drops
Drug: Liposic EDO
Drug: OcuFresh Eye Wash
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Objective Evaluation of Ocular Surface Lubricants

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Tear Film Properties [ Time Frame: Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit. ] [ Designated as safety issue: No ]

    The wavefront sensor instrument measures the eye's ability to create a sharp image.

    Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea.

    A thermal (T) imaging system provides thermal maps of the subject's eyes and face adjacent to the eyes.

    A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prior to instillation of the eye drop and after each set of measurements.



Enrollment: 20
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drop Administration Drug: B & L Soothe Lubricant Eye Drops
Eye Drop
Drug: Liposic EDO
Eye Drop
Drug: OcuFresh Eye Wash
Saline drop

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375582

Locations
United States, New York
Flaum Eye Institute at the University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Bausch & Lomb Incorporated
Investigators
Principal Investigator: James V Aquavella, MD University of Rochester
  More Information

No publications provided

Responsible Party: James V. Aquavella, MD, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01375582     History of Changes
Other Study ID Numbers: 35809
Study First Received: June 14, 2011
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Dry Eye
tear film
lipid
tear volume
environmental chamber
thermal imaging

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014