Phentolamine Eye Drops for Night Vision Impairment
(LYNX-2 Trial)
Recruiting in Palo Alto (17 mi)
+23 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Ocuphire Pharma, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.
Do I need to stop my current medications to join the trial?
Yes, you must stop using any topical prescription or over-the-counter ophthalmic medications, including artificial tear drops, at least 7 days before the trial and until it is completed. Additionally, you cannot change the dosage or start new systemic adrenergic or cholinergic drugs within 7 days before the trial or during the study.
What data supports the idea that Phentolamine Eye Drops for Night Vision Impairment is an effective treatment?
The available research shows that Phentolamine Eye Drops can help with night vision problems by reducing pupil size and improving vision clarity in dim light. In a study, patients with night vision disturbances experienced better image quality after using the drops. Compared to another treatment, pilocarpine, which helps with close-up vision but can reduce night vision, Phentolamine Eye Drops specifically target night vision issues, making them a more suitable option for this condition.
12345What safety data is available for Phentolamine Eye Drops?
The ORION-1 trial evaluated the long-term safety and efficacy of Phentolamine Mesylate Ophthalmic Solution (PMOS) in a glaucomatous, presbyopic population, indicating its safety profile in these patients. Additionally, PMOS was shown to reverse pharmacologically induced mydriasis in a Phase 2b trial, suggesting it is well-tolerated for this use.
12678Is the drug Phentolamine Ophthalmic Solution a promising treatment for night vision problems?
Yes, Phentolamine Ophthalmic Solution shows promise as it can improve vision in low light by reducing pupil size, enhancing visual clarity, and helping with issues like glare and halos. It also helps reverse eye dilation after exams, making it easier for patients to regain normal vision quickly.
12379Eligibility Criteria
This trial is for individuals experiencing night vision problems after refractive eye surgery. Participants should have stable post-surgery vision and no other ongoing eye conditions that could affect the study results.Inclusion Criteria
I've had eye surgery like LASIK and now have night vision issues.
mLCVA ≤ 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/63 Snellen or worse) in at least 1 eye using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m
I am 18 years old or older.
+5 more
Exclusion Criteria
I have had changes in my vision over time.
My blood pressure is not higher than 160/105 mmHg.
Known hypersensitivity to any topical alpha-adrenoceptor antagonists
+23 more
Participant Groups
The trial tests if a special eye drop solution, Phentolamine Ophthalmic Solution at 0.75%, can improve low-light visual sharpness in people with night vision issues post-eye surgery, compared to a placebo (a substance with no active drug).
2Treatment groups
Active Control
Placebo Group
Group I: 0.75% phentolamine ophthalmic solutionActive Control1 Intervention
Daily dosing
Group II: phentolamine ophthalmic solution vehiclePlacebo Group1 Intervention
Daily dosing
Phentolamine Ophthalmic Solution is already approved in United States for the following indications:
🇺🇸 Approved in United States as Ryzumvi for:
- Reversal of pharmacologically-induced mydriasis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
United States, North CarolinaGarner, NC
United States, Rhode IslandWarwick, RI
United StatesBakersfield, CA
United States TorranceTorrance, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Ocuphire Pharma, Inc.Lead Sponsor
Viatris Inc.Industry Sponsor
References
Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Presbyopic Glaucoma Patients in a Randomized Phase 2b Clinical Trial. [2022]Phentolamine mesylate ophthalmic solution (PMOS), applied to the eye topically, was shown previously to have beneficial effects in patients with dim light vision disturbances (DLD), including decreased pupil diameter (PD), improved best-corrected distance visual acuity (BCDVA), as well as lower intraocular pressure (IOP). The ORION-1 trial evaluated the long-term safety and efficacy of PMOS in a glaucomatous, presbyopic population.
Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial. [2023]After a dilated eye examination, many patients experience symptoms of prolonged light sensitivity, blurred vision, and cycloplegia associated with pharmacological mydriasis. Phentolamine mesylate ophthalmic solution (PMOS) may expedite the reversal of mydriasis in patients, potentially facilitating return to functional vision and reducing barriers to obtaining dilated eye examinations.
A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances. [2022]Dim light vision disturbances (DLD) comprise a wide range of symptoms affecting the quality of vision at low illumination including glare, halos, and starbursts. This exploratory study investigated 1.0% phentolamine mesylate ophthalmic solution (PMOS) as a treatment to improve vision and image quality for patients with DLD.
Topical Review: Pilocarpine-induced Miosis as Help for Early Presbyopes? [2022]The clinical utility of ophthalmic pilocarpine-induced pupil constriction to help overcome image blur of close-up targets in patients with failing accommodation is examined.Pilocarpine in low-concentration ophthalmic solution eye drops constricts the pupil to approximately 2 mm and thus reduces defocus blur. To gain regulatory approval of this drug for the treatment of presbyopia, clinical trials were conducted with 1.25% pilocarpine. Near vision was improved in a modest proportion of early presbyopes: between 12 and 22% more patients reached criterion near visual acuity than with a placebo, depending on conditions. The drug is well tolerated, and its effect has onset of only minutes and lasts several hours. Small pupils will cause diminished night vision and may have an impact on distance acuity to which possible minor drug-induced accommodative spasms could contribute. The therapy has a role for patients who want to postpone or briefly pause dioptric supplementation of their failing accommodation. No convincing case has been made for one version of ophthalmic pilocarpine over another.
The relative potencies of cholinomimetics and muscarinic antagonists on the rat iris in vivo: effects of pH on potency of pirenzepine and telenzepine. [2020]The effects of cholinomimetics and muscarinic antagonists were compared following topical administration to the eyes of anaesthetized rats. For tests with cholinomimetics, clonidine (0.3 mg/kg) was used to induce mydriasis via central inhibition of parasympathetic tone. Full, dose-dependent miosis was induced by acetylcholinesterase inhibitors [physostigmine greater than neostigmine greater than tetrahydroaminoacridine (THA)] and by membrane channel blockers (4-aminopyridine greater than 3,4-diaminopyridine). Oxotremorine was the most potent direct agonist tested [oxotremorine greater than arecaidine propargylester (APE) greater than arecoline greater than carbachol greater than ethoxyethyltrimethyl-ammonium iodide (EOE) greater than RS 86]. Some putative M1 selective agonists were weakly active or behaved as partial agonists (pilocarpine greater than AH6405 greater than Mc-A-343 greater than isoarecoline). Of the antagonists, compared in non-clonidine treated rats, scopolamine hydrochloride was the most potent. Of the receptor selective antagonists the M2 (ileal) selective compounds hexahydrosiladifenidol and 4-DAMP were more potent than either M1 selective (pirenzepine, telenzepine) or M2 (atrial) selective (AF DX 116) drugs. These data tentatively suggest the involvement of an M2 (ileal) type muscarinic receptor. Potency was lower for quaternary structures, probably due to impaired corneal penetration. The potency of pirenzepine and telenzepine was increased 60-fold at low pH following topical administration. Acid induced corneal damage does not appear to account for this potency shift as the effects of scopolamine and several agonists (oxotremorine, pilocarpine and McNA-343) were not substantially altered by acid media. For pirenzepine the potency shift appears to be related to protonation of the second amino group (N1) in the piperazine tail (pKa = 2.05).(ABSTRACT TRUNCATED AT 250 WORDS)
Mydriatic effectiveness of hydroxyamphetamine. [2013]For routine mydriasis, many clinicians prefer to utilize a combination of adrenergic and anticholinergic agents. Some clinicians, however, omit the adrenergic agent because of a real or perceived fear of inducing adverse systemic side effects. The agent most often implicated in causing side effects is 10% phenylephrine. Although the 2 1/2% concentration rarely results in adverse systemic side effects when applied topically for pupillary dilation, we undertook this study to determine whether another adrenergic agent, 1% hydroxyamphetamine, which lacks the notoriety of phenylephrine, would be equally effective in producing mydriasis.
[Adverse effects of neosynephrine]. [2013]Phenylephrine is widely used to obtain a sympathomimetic mydriaticum, however eye drops may be followed by a certain number of adverse effects notably cardio-vascular as our observation shows, but also allergic effects, irian pigment liberation in the anterior chamber and iatrogenic corneal oedema.
Safety and toleration of oxymetazoline ophthalmic solution. [2013]Two studies were carried out in volunteers without any abnormal ocular conditions to assess the effects and safety of an ophthalmic preparation of oxymetazoline (0.025%). In the first study in which oxymetazoline was compared with placebo and phenylephrine, the results of infra-red electronic pupillography showed that oxymetazoline in therapeutic doses had no effect on pupil size or near point recession. The second study, which was a double-blind forced choice comparison of two different formulations against placebo and 1% naphazoline, showed from assessments of the degree of ocular discomfort and hyperaemia that oxymetazoline was well tolerated and the subjects preferred oxymetazoline in a boric acid rather than in a phosphate solution.
[The usage of nasal drops Tyzine in otorhinolaryngology]. [2015]In this research the authors presented their experiences in the treatment of non-complicated and complicated acute mucous membranous rhinitis with application of shrinking nasal drops Tyzine as a locally affective remedy assisting the therapy. The aim of this research was the estimation of the efficiency of Tyzine drops with mucous membranous rhinitis, their effect on the efficiency of the ciliary transport and stating the probable side effects occurring after their application. 80 persons were observed--60 adults who were treated with 0.1% solution oftetrazoline hydrochloride and 20 children who were given 0.05% solution. To state the condition of the ciliary transport within mucous membrane, a saccharine test was conducted with all examined persons on the 1st and 5th-7th days of treatment and on the 21st day after completing the therapy. The results of the observation seem to be positive as for as the efficiency of nasal drops Tyzine under the stipulation that the drops are reasonably applied and according to the doctor's recommendation.