Status:
TERMINATED
Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use
Lead Sponsor:
Allergan
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).
Eligibility Criteria
Inclusion
- Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of "not applicable"
- In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye
Exclusion
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
- History of nasal or sinus surgery
- Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
- Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit
- Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
Key Trial Info
Start Date :
October 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03274999
Start Date
October 18 2017
End Date
November 9 2017
Last Update
March 8 2021
Active Locations (1)
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1
Ocular Technology Group International
London, United Kingdom, SW1E 6AU