Objective Evaluation of Ocular Surface Lubricants in Two Environments
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Purpose
This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.
| Condition | Intervention |
|---|---|
|
Dry Eye |
Drug: B & L Soothe Lubricant Eye Drops Drug: Liposic EDO Drug: OcuFresh Eye Wash |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Objective Evaluation of Ocular Surface Lubricants |
- 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.
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
-
Drug: B & L Soothe Lubricant Eye Drops
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 tear film and lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using wavefront sensing, ellipsometry, and thermal 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 |
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| Contact: Research Coordinator | 585-273-4870 | eyeclinicalstudies@urmc.rochester.edu |
| United States, New York | |
| Flaum Eye Institute at the University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Research Coordinator 585-273-4870 eyeclinicalstudies@urmc.rochester.edu | |
More Information
No publications provided
| Responsible Party: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01375582 History of Changes |
| Other Study ID Numbers: | B&L 35809 |
| Study First Received: | June 14, 2011 |
| Last Updated: | May 3, 2012 |
| 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 June 17, 2013