Open Angle Glaucoma
Conditions
Keywords
glaucoma, NCX 470, nitric oxide, prostaglandin analogue
Brief summary
This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.
Interventions
DRUGNCX 470
NCX 470 0.1% vs Placebo
DRUGPlacebo
NCX 0.1% vs Placebo
Sponsors
Nicox Ophthalmics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥18 years of age 2. Either gender 3. Subjects without glaucoma 4. Qualifying IOP at Screening Visit
Exclusion criteria
1. Narrow anterior chamber angles or disqualifying central corneal thickness in either eye 2. Clinically significant ocular disease in either eye 3. Uncontrolled systemic disease 4. Serious hypersensitivity to topical anesthetic eye drops 5. Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in AHD | 8 days | The primary efficacy endpoint is change from baseline in aqueous humor dynamics AHD). AHD is calculated by using well establish techniques which include capturing the following: Aqueous humor flow rates from fluorescein clearance; Outflow facility using constant weigh tonography; Episcleral venous pressure using a venomanometer. The change in ADH will be calculate in normals following 8 (±1) days of dosing of NCX 470 0.1% compared to placebo. |
Countries
United States
Outcome results
None listed