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Prostaglandin Analog

NCX 470 for Glaucoma (Denali Trial)

Phase 3
Recruiting
Research Sponsored by Nicox Ophthalmics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Denali Trial Summary

This trial will study whether NCX 470 Ophthalmic Solution is safe and effective in lowering eye pressure in people with ocular hypertension or glaucoma.

Who is the study for?
This trial is for people who can consent to participate and have open-angle glaucoma or ocular hypertension in both eyes. They must show qualifying eye pressure at different times of the day and have good corrected vision in each eye. Those with recent serious eye surgery, uncontrolled diseases, significant other eye conditions, narrow chamber angles or unsuitable corneal thickness cannot join.Check my eligibility
What is being tested?
The study tests NCX 470 Ophthalmic Solution against Latanoprost to see which is better at lowering intraocular pressure in patients with high eye pressure or open-angle glaucoma. Participants will be randomly assigned to one of these treatments and use it daily for up to a year.See study design
What are the potential side effects?
Possible side effects may include local irritation, redness, discomfort in the eyes, changes in eyelash growth or pigmentation around the eyes. Systemic side effects are rare but could potentially affect breathing or heart rate.

Denali Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with glaucoma or high eye pressure in both eyes.
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My eye pressure was measured 3 times a day during 2 visits after stopping any eye pressure medication.

Denali Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline IOP
Secondary outcome measures
Change from baseline in diurnal IOP
Frequency and incidence of treatment-emergent adverse events
Rate of discontinuation

Denali Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NCX 470 0.1%Experimental Treatment1 Intervention
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
Group II: Latanoprost 0.005%Active Control1 Intervention
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes

Find a Location

Who is running the clinical trial?

Nicox Ophthalmics, Inc.Lead Sponsor
6 Previous Clinical Trials
2,122 Total Patients Enrolled
2 Trials studying Ocular Hypertension
1,326 Patients Enrolled for Ocular Hypertension
Nicox OphthalmicsStudy DirectorNicox Ophthalmics, Inc.
2 Previous Clinical Trials
260 Total Patients Enrolled
Jose L Boyer, PhDStudy DirectorNicox Ophthalmics, Inc.
2 Previous Clinical Trials
894 Total Patients Enrolled
1 Trials studying Ocular Hypertension
670 Patients Enrolled for Ocular Hypertension

Media Library

Latanoprost 0.005% (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04630808 — Phase 3
Ocular Hypertension Research Study Groups: NCX 470 0.1%, Latanoprost 0.005%
Ocular Hypertension Clinical Trial 2023: Latanoprost 0.005% Highlights & Side Effects. Trial Name: NCT04630808 — Phase 3
Latanoprost 0.005% (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04630808 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will people who are over the age of 40 be able to participate in this clinical trial?

"This study's inclusion criteria allow for participants that are aged 18 to 84."

Answered by AI

What is the most severe reaction that has been linked with NCX 470 0.1%?

"There is some evidence to support NCX 470 0.1% efficacy and multiple rounds of data that suggest the safety of the drug, so it received a score of 3."

Answered by AI

Are there any areas in this research project that still need participants?

"That is correct. As of 9/21/2022, the most recent update, this clinical trial is actively searching for 670 participants from a single location."

Answered by AI

What are the benefits of NCX 470 0.1% ?

"NCX 470 0.1% is a medication used to treat open angle glaucoma, increased intra ocular pressure, and chronic angle-closure glaucoma. This medication is also taken as a preventative measure for patients that have undergone peripheral iridotomy or laser iridoplasty."

Answered by AI
~174 spots leftby Jun 2025