NCX 470 for Glaucoma
(Denali Trial)
Recruiting in Palo Alto (17 mi)
+76 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Nicox Ophthalmics, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing NCX 470 eye drops to see if they can safely and effectively lower eye pressure in people with high eye pressure or glaucoma. The goal is to protect their vision by reducing the pressure inside their eyes. NCX 470 is a nitric oxide (NO)-donating bimatoprost with clinically demonstrated pressure-lowering effects.
Do I have to stop taking my current medications for the trial?
The trial requires a washout period for any IOP-lowering medications you are currently taking.
What data supports the idea that NCX 470 for Glaucoma is an effective drug?
The available research does not provide any data on NCX 470 for Glaucoma. The studies listed focus on other drugs and conditions, such as migraine treatments and nasal sprays, without mentioning NCX 470 or its effectiveness for Glaucoma.
12345What safety data is available for NCX 470 in glaucoma treatment?
The safety data for NCX 470, which may be related to treatments like latanoprost and bimatoprost, includes findings from various studies. Bimatoprost, a similar agent, has been shown to effectively lower intraocular pressure in glaucoma patients, with common side effects being mild conjunctival hyperaemia and eyelash growth. Long-term use has not raised safety concerns. Comparisons with latanoprost and timolol indicate that bimatoprost is effective and generally well-tolerated, suggesting a favorable safety profile for related treatments like NCX 470.
678910Is NCX 470 a promising drug for glaucoma?
Yes, NCX 470 is a promising drug for glaucoma. It combines latanoprost, which is effective in lowering eye pressure, with a nitric oxide component that helps relax blood vessels. This dual action makes it potentially more effective in reducing eye pressure, which is crucial for treating glaucoma.
1112131415Eligibility Criteria
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.Inclusion Criteria
Your vision with glasses or contacts must be good in each eye.
Ability to provide informed consent and follow study instructions
I have been diagnosed with glaucoma or high eye pressure in both eyes.
+1 more
Exclusion Criteria
I have had complex or specific glaucoma surgery in either eye.
I haven't had eye surgery or severe eye trauma in the last 6 months.
I have a disease that is not currently under control.
+2 more
Participant Groups
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.
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
Latanoprost 0.005% is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Xalatan for:
- Open-angle glaucoma
- Ocular hypertension
🇨🇦 Approved in Canada as Xalatan for:
- Open-angle glaucoma
- Ocular hypertension
- Angle-closure glaucoma treated with peripheral iridotomy or laser iridoplasty
🇪🇺 Approved in European Union as Monoprost for:
- Open-angle glaucoma
- Ocular hypertension
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nicox Clinical SiteTroy, NY
Eye Research FoundationNewport Beach, CA
Nicox Clinical SiteHouston, TX
Nicox Clinical SiteMemphis, TN
More Trial Locations
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Who Is Running the Clinical Trial?
Nicox Ophthalmics, Inc.Lead Sponsor
References
Lack of pharmacokinetic interaction between butorphanol tartrate nasal spray and sumatriptan succinate. [2019]The pharmacokinetics of butorphanol tartrate given in a nasal spray with and without the co-administration of sumatriptan succinate were studied in 24 healthy men and women. In this crossover design study, all subjects received 2 treatments: a single 1-mg dose of butorphanol nasal spray and a 1-mg dose of butorphanol nasal spray plus a single 6-mg subcutaneous (SC) dose of sumatriptan. There was a two-week washout period between sessions. Serial blood samples were collected and plasma samples analyzed using validated radioimmunoassay and high-performance liquid chromatography/electrochemical procedures to determine the concentrations of unchanged butorphanol and sumatriptan, respectively. There were no statistically significant differences for butorphanol between the 2 treatments on any of the following pharmacokinetic parameters: Cmax, tmax, AUC, t1/2, CL/f, and Vz/f. Similarly, the pharmacokinetic parameters obtained for sumatriptan (given with butorphanol nasal spray) were comparable with the literature values obtained for a single 6-mg SC dose of sumatriptan. These data show a lack of pharmacokinetic interaction between butorphanol nasal spray and sumatriptan. Butorphanol nasal spray and sumatriptan were well tolerated. The adverse experience profiles of butorphanol nasal spray were comparable between the treatments, with and without sumatriptan. It can be concluded that regimens of butorphanol nasal spray and sumatriptan need not be changed for either pharmacokinetic or safety considerations when the two compounds are co-administered in treating acute migraine attacks.
Antimigraine efficacy of telcagepant based on patient's historical triptan response. [2022]To evaluate whether the same or different patients respond to triptans and telcagepant.
Using patient-centered endpoints to determine the cost-effectiveness of triptans for acute migraine therapy. [2006]The objective of this study was to use the patient-centered efficacy measurements of sustained pain free and sustained pain free with no adverse events to compare the relative cost-effectiveness of 6 oral triptans in the treatment of acute migraine. Adverse event and sustained pain-free rates were obtained from a comprehensive meta-analysis of 53 clinical trials of oral triptans. Efficacy and tolerability were assumed to be independent. Average wholesale prices were in US dollars as of May 10, 2004. The meta-analysis of oral triptans reported that almotriptan 12.5 mg (Axert) exhibited the highest sustained pain-free rate (25.9%), with the lowest rate associated with eletriptan 20 mg (Relpax) (10.6%). In addition, almotriptan 12.5 mg possessed the lowest overall absolute adverse event rate (14.2%), with the highest adverse event rate exhibited by eletriptan 80 mg (53.9%). To attain 100 sustained pain-free patients, almotriptan 12.5 mg and rizatriptan 10 mg (Maxalt) proved to be the most cost-effective triptans, costing $7120 and $7427, respectively; the least cost-effective were naratriptan 2.5 mg (Amerge) ($13,736) and eletriptan 20 mg ($16,104). To attain 100 sustained pain-free with no adverse events patients, almotriptan 12.5 mg was the most cost-effective triptan ($8298) and the least cost-effective were eletriptan 20 mg ($25,521) and eletriptan 80 mg ($29,614). At average wholesale prices as of May 10, 2004, almotriptan 12.5 mg achieved the highest level of cost-effectiveness using either sustained pain free or sustained pain free with no adverse events as endpoints.
Long-term efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol. [2016]Beclomethasone dipropionate (BDP) nasal aerosol has an established efficacy and safety profile for short-term allergic rhinitis (AR) treatment. However, managing perennial AR (PAR) symptoms often requires long-term treatment. This study evaluates efficacy and safety of long-term treatment with BDP nasal aerosol in PAR patients. In this double-blind, placebo-controlled study, patients (≥12 years [n = 529]) were randomized 4:1 to once-daily treatment with BDP nasal aerosol at 320 μg or placebo. The primary efficacy end point was change from baseline in weekly averages of patient-reported 24-hour reflective total nasal symptom score (rTNSS) over 30 weeks. Safety and tolerability of BDP nasal aerosol were also assessed. Ocular safety, including changes in intraocular pressure and severity of lens opacities (nuclear opalescence, nuclear color, cortical lens opacity, and posterior subcapsular lens opacity), was measured for patients who completed 52 weeks of treatment (n = 245). Across 30 and 52 weeks, BDP nasal aerosol significantly improved rTNSS and instantaneous TNSS (iTNSS) versus placebo (least-squares mean treatment difference, rTNSS, -0.97 for 30 weeks and -1.09 for 52 weeks, p
Comparison of rizatriptan 10 mg vs. naratriptan 2.5 mg in migraine. [2017]Rizatriptan (MAXALT(TM), Merck & Co., Inc.) is a selective 5-HT(1B/1D) receptor agonist with rapid oral absorption and early onset of action for the acute treatment of migraine. This randomized, double-masked, double-dummy, placebo-controlled study compared rizatriptan 10 mg to naratriptan (NARAMIG(TM), AMERGE(TM), both Glaxo Wellcome plc) 2.5 mg in 522 patients treating a single migraine attack. Rizatriptan was more effective than naratriptan. Rizatriptan provided earlier headache relief than naratriptan (hazard ratio 1.62, p
Ocular hypotensive efficacy of bimatoprost when used as a replacement for latanoprost in the treatment of glaucoma and ocular hypertension. [2018]To evaluate the clinical effectiveness of bimatoprost (Lumigan, Allergan, Inc.) when used as a replacement for latanoprost (Xalatan, Pharmacia) in the treatment of glaucoma and ocular hypertension.
Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study. [2019]To evaluate intraocular pressure (IOP)-lowering efficacy, tolerability, and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% (Ganfort) among German patients.
Efficacy and safety of switching from topical latanoprost to bimatoprost in patients with normal-tension glaucoma. [2018]The aim of this study was to evaluate the efficacy and safety of bimatoprost in Japanese patients with normal-tension glaucoma (NTG) who showed insufficient response to latanoprost.
An update on bimatoprost in glaucoma therapy. [2019]Bimatoprost, a prostamide, effectively lowers intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. In clinical trials, bimatoprost has demonstrated superiority to the beta-adrenergic antagonist timolol and has consistently provided approximately 1-2 mmHg greater mean IOP lowering than the prostaglandin latanoprost. Bimatoprost is more effective than either timolol or latanoprost in allowing patients to reach the low target pressures that best protect the visual field. Patients on bimatoprost therapy achieve low pressures throughout the day and night. Moreover, 1-year trials have shown that the efficacy of bimatoprost is sustained with long-term use. The most common side effects have been conjunctival hyperaemia, graded as trace or mild, and eyelash growth. No safety concerns have arisen in postmarketing surveillance. Bimatoprost appears to be a valuable new agent for glaucoma therapy.
A 6-month randomized clinical trial of bimatoprost 0.03% versus the association of timolol 0.5% and latanoprost 0.005% in glaucomatous patients. [2018]New effective hypotensive agents have been recently introduced into clinical practice, but often more than one drug has to be used to prevent further visual field loss. The aim of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.03% compared with the association of timolol 0.5% and latanoprost 0.005% in open-angle glaucoma patients.
MERCURY-3: a randomized comparison of netarsudil/latanoprost and bimatoprost/timolol in open-angle glaucoma and ocular hypertension. [2023]PURPOSE   : To compare the efficacy and safety of the fixed-dose combination (FDC) of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution (NET/LAT; Roclanda®) with bimatoprost 0.03%/timolol maleate 0.5% (BIM/TIM; Ganfort®) ophthalmic solution in the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).
A dual acting compound with latanoprost amide and nitric oxide releasing properties, shows ocular hypotensive effects in rabbits and dogs. [2018]The IOP lowering effects of NCX 139, a new chemical entity comprising latanoprost amide and a NO-donating moiety, were compared to those of the respective des-nitro analog in in vitro assays and in rabbit and dog models of ocular hypertension. The NO donor, molsidomine as well as the prostamide bimatoprost (Lumigan(®)) and the prostaglandin agonist, latanoprost (Xalatan(®)) were also investigated for comparison. NCX 139 but not its des-nitro analog resulted in NO-mediated vascular relaxant effect in pre-contracted rabbit aortic rings (EC(50)=0.70±0.06 μM; E(max)=80.6±2.9%). Like bimatoprost (IC(50)=3.07±1.3 μM) or latanoprost (IC(50)=0.48±0.15 μM), NCX 139 displaced (3)H-PGF2α binding on recombinant human prostaglandin-F (FP) receptors with an estimated potency of 0.77±0.13 μM. In transient ocular hypertensive rabbits, bimatoprost and latanoprost were not effective while molsidomine elicited a dose-dependent reduction of IOP confirming the responsiveness of rabbits to NO but not to FP receptor agonists. NCX 139 tested at a therapeutically relevant dose, significantly lowered IOP while the des-nitro analog was not effective (0.03% NCX 139, Δ(max)=-12.8±2.0 mmHg). In glaucomatous dogs, 0.03% NCX 139 decreased IOP to a greater extent compared to an equimolar dose of the respective des-nitro derivative (Δ(max)=-4.6±1.0 and -2.7±1.3 mmHg, respectively for NCX 139 and its des-nitro analog). Albeit with low potency, NCX 139 also resulted effective in normotensive dogs while it did not reduce IOP in normotensive rabbits. NCX 139, a compound targeting two different and important mechanisms, is endowed with ocular hypotensive effects more evident in hypertensive conditions which may be of interest in the search of more effective treatments for hypertensive glaucoma.
Bimatoprost - a review. [2015]Bimatoprost is a synthetic prostamide analog that is efficacious in the treatment of open-angle glaucoma, ocular hypertension and other forms of glaucoma. It reduces intraocular pressure (IOP) by increasing uveoscleral and trabecular outflow. When used as a 0.03% topical preparation once daily, it demonstrates sustained lowering of IOP of 7 - 8 mmHg over a 24-h period. The drug has been found to be more effective than timolol. In some studies it has shown greater ability to lower IOP when compared with other prostaglandin analogs; whereas in others all three clinically used prostaglandin analogs were found to be equally effective. It shows good IOP reduction when used in combination with other glaucoma medications. A common side effect includes mild conjunctival hyperemia, which is generally reversible. Other side effects include periorbital pigmentation, discomfort, ocular surface hyperemia and skin changes. Pharmacoeconomic data indicate that bimatoprost is cost effective in the treatment of open-angle glaucoma.
Prostaglandin analog treatment of glaucoma and ocular hypertension. [2018]To review available data related to the use of prostaglandin analogs (bimatoprost, latanoprost, travoprost, unoprostone) in the management of ocular hypertension and open-angle glaucoma.
Prostaglandin analogues in the treatment of glaucoma. [2018]Prostaglandin (PG) analogues are a new class of ocular hypotensive drugs that have been developed for the treatment of open angle glaucoma. Two of these drugs, latanoprost and unoprostone, are presently commercially available. Latanoprost was introduced in 1996 in the US and Europe. Presently it enjoys the most widespread use and is the most well documented drug of this group. It reduces the intraocular pressure (IOP) by a mechanism of action different from other drugs; namely by increasing the uveoscleral outflow. The aqueous inflow is not affected. The optimal dose regimen is one drop of 50 microg/ml once daily, which reduces the IOP by approximately 30% in patients with glaucoma. A more pronounced ocular hypotensive effect is demonstrated when latanoprost is combined with other glaucoma therapies, including beta-blockers, adrenergic and cholinergic agonists or carbonic anhydrase inhibitors. Latanoprost is well tolerated. The drug reaches a plasma concentration below that needed for stimulation of the FP-receptor, which may explain its favourable systemic tolerability profile. The major ocular adverse effect is increased iris pigmentation, which is due to increased synthesis of melanin in the melanocytes of the iris stroma. It is most frequently seen in green-brown eyes and it is probably permanent. A low frequency of cystoid macular oedema has also been reported, predominantly in predisposed eyes. Unoprostone was launched in Japan in 1994, but there is little experience with this drug outside the Japanese market and the documentation is more limited. Its main mechanism of action is on outflow, but this is not yet fully elucidated. The recommended dosage regimen is 1 drop of 1.2 mg/ml twice daily. No comparative studies in humans between the 2 drugs have yet been published.