Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2015 |
| End Date: | May 2016 |
| Contact: | Stephanie Baba |
| Email: | stephanie@oculeve.com |
| Phone: | 415-580-6176 |
Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
The objectives of this study are:
- To compare the change in levels of tear proteins and inflammatory mediators pre and
post administration between the intranasal and extranasal applications
- To compare the goblet cell count following application between the intranasal and
extranasal applications
- To compare fluorescein tear clearance with the application of the device intranasally
and extranasally applications
- To compare the change in levels of tear proteins and inflammatory mediators pre and
post administration between the intranasal and extranasal applications
- To compare the goblet cell count following application between the intranasal and
extranasal applications
- To compare fluorescein tear clearance with the application of the device intranasally
and extranasally applications
In this study, subjects will participate for three study days during up to a 44 day period,
consisting of a screening examination to determine eligibility on one day and study
applications on two different days. There are two applications, intranasal and extranasal.
Subjects will receive both applications, in random sequence, one at each of the two
application days (Visit 2 and Visit 3). The two applications consist of:
- Active intranasal device application
- Active extranasal device application
consisting of a screening examination to determine eligibility on one day and study
applications on two different days. There are two applications, intranasal and extranasal.
Subjects will receive both applications, in random sequence, one at each of the two
application days (Visit 2 and Visit 3). The two applications consist of:
- Active intranasal device application
- Active extranasal device application
Inclusion Criteria:
- Bilateral dry eyes
- Capable of providing written informed consent
Exclusion Criteria:
- Chronic or recurring epistaxis (nosebleeds)
- Blood coagulation disorder
- Uncontrolled or poorly controlled diabetes
- Heart or pulmonary disease
- Females who are pregnant, planning a pregnancy or nursing
We found this trial at
2
sites
Houston, Texas 77030
Principal Investigator: Stephen Pflugfelder, MD
Phone: 713-798-8419
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Sacramento, California 95815
Principal Investigator: Richard Lewis, MD
Phone: 916-649-1515
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