Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution
Phase 2
Recruiting
- Conditions
- Open Angle Glaucoma
- Interventions
- Drug: PlaceboDrug: NCX 470
- Registration Number
- NCT05938699
- Lead Sponsor
- Nicox Ophthalmics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- ≥18 years of age
- Either gender
- Subjects without glaucoma
- Qualifying IOP at Screening Visit
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Exclusion Criteria
- Narrow anterior chamber angles or disqualifying central corneal thickness in either eye
- Clinically significant ocular disease in either eye
- Uncontrolled systemic disease
- Serious hypersensitivity to topical anesthetic eye drops
- Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Artificial tears - one drop in the randomized eye once a day for 8 days NCX 470 0.1% NCX 470 NCX 470 0.1% - one drop in the randomized eye once a day for 8 days
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States