Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Dry Eye Disease
In brief
The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry eye disease.
Key facts
- Study ID
- NCT02824913
- Run by
- Parion Sciences
- People needed
- 1
- Starts
- 2016-07-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2018-08-31
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provide written informed consent
- Male or female subjects aged 18 to 80 years
- Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis
- Have normal lid anatomy
- Subjects must:
- Remain on current medications for the duration of the study and have been on the current medication regimen at least during the past 28 days
You may not qualify if…
- Have undergone refractive eye surgery in either eye during the past 12 months
- Have undergone uncomplicated cataract surgery in either eye during the past 3 months
- Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed)
- Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1
- Subjects that have a systemic, multi-organ disease requiring active medical or surgical treatment are excluded with the exception of subjects with SS or GVHD
- Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens.
- Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis
Where it is running
- Bascom Palmer Eye Institute, University of Miami Health System — Plantation, Florida, United States
Full record on ClinicalTrials.gov
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