Dry Eye Disease Clinical Trial
Official title:
Randomized, Crossover Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Characterized by Low Tear Volume
NCT number | NCT02824913 |
Other study ID # | P-321-201 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | March 2017 |
Verified date | December 2017 |
Source | Parion Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Provide written informed consent 2. Male or female subjects aged 18 to 80 years 3. Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis 4. Have normal lid anatomy 5. Subjects must: 1. 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 Exclusion Criteria: 1. Have undergone refractive eye surgery in either eye during the past 12 months 2. Have undergone uncomplicated cataract surgery in either eye during the past 3 months 3. Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed) 4. Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1 5. 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 6. Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens. 7. Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis |
Country | Name | City | State |
---|---|---|---|
United States | Bascom Palmer Eye Institute, University of Miami Health System | Plantation | Florida |
Lead Sponsor | Collaborator |
---|---|
Parion Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo | Tear meniscus volume, from measurements of tear meniscus area by UHR-OCT and the length of the eyelid was estimated over time (0 to 6 hours) following administration of placebo or P-321 Ophthalmic Solution. | Pre-dose and up to six hours after dose | |
Secondary | Lower Tear Meniscus Height as Measured by the Keratograph 5M | Tear meniscus height of the inferior eyelid was measured with the Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution | Pre-dose and up to six hours after dose | |
Secondary | Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M | Tear meniscus height of the inferior eyelid was measured by UHR-OCT and Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution | Pre-dose and up to six hours after dose | |
Secondary | Adverse Events | Number of patients experiencing adverse events comparing P-321 to placebo | 2 or 7 hours |
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