OK-101 for Neuropathic Corneal Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Okyo Pharma Ltd
Must not be taking: Topical medications
Disqualifiers: Ocular infection, Intraocular inflammation, Corneal scar, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?The primary objective of this study, in subjects with Neuropathic Corneal Pain, is to evaluate the efficacy and safety of OK-101 0.05% and 0.1% as compared to placebo instilled 4 times/day in subjects with neuropathic corneal pain, as assessed by visual analogue scale (VAS).
Will I have to stop taking my current medications?
You will need to stop using any topical eye medications 8 days before the trial starts. However, you can continue taking your oral medications for neuropathic corneal pain as long as there are no changes during the study.
How is the drug OK-101 different from other treatments for neuropathic corneal pain?
OK-101 is unique because it is specifically being studied for neuropathic corneal pain, a condition with limited treatment options, and it may offer a novel approach compared to existing therapies that often focus on dry eye disease or other types of neuropathic pain.
12345Eligibility Criteria
This trial is for individuals experiencing neuropathic corneal pain, which is a type of nerve pain in the eye. Participants should be able to apply eye drops four times a day. The specific inclusion and exclusion criteria are not provided, but typically these would detail necessary conditions or characteristics participants must have or lack.Inclusion Criteria
I am 18 years old or older.
Satisfying all Informed Consent requirements
I have had symptoms like burning or pain in my eye for at least 3 months.
+4 more
Exclusion Criteria
Evidence of any corneal scar/corneal edema
I have signs of inflammation inside my eye.
I have not had eye surgery in the last 3 months.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive OK-101 or placebo instilled in affected eye(s) four times daily for 12 weeks
12 weeks
Regular visits for monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests two concentrations of OK-101 (0.05% and 0.1%) against a placebo to see if they can reduce eye pain when used as eye drops four times daily. Effectiveness will be measured using a visual analogue scale (VAS), which helps patients rate their pain level.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm BExperimental Treatment1 Intervention
OK-101, 0.1% - one drop of study drug (0.1%) will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks.
Group II: Arm AExperimental Treatment1 Intervention
OK-101, 0.05% - one drop of study drug (0.05%) will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks
Group III: Arm CPlacebo Group1 Intervention
Placebo - one drop of placebo will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tufts Medical CenterBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Okyo Pharma LtdLead Sponsor
Tufts Medical CenterCollaborator
References
Neuropathic Corneal Pain: Approaches for Management. [2022]Neuropathic pain is caused by a primary lesion or dysfunction of the nervous system and can occur in the cornea. However, neuropathic corneal pain (NCP) is currently an ill-defined disease. Patients with NCP are extremely challenging to manage, and evidence-based clinical recommendations for the management of patients with NCP are scarce. The objectives of this review are to provide guidelines for diagnosis and treatment of patients with NCP and to summarize current evidence-based literature in this area. We performed a systematic literature search of all relevant publications between 1966 and 2017. Treatment recommendations are, in part, based on methodologically sound randomized controlled trials (RCTs), demonstrating superiority to placebo or relevant control treatments, and on the consistency of evidence, degree of efficacy, and safety. In addition, the recommendations include our own extensive experience in the management of these patients over the past decade. A comprehensive algorithm, based on clinical evaluation and complementary tests, is presented for diagnosis and subcategorization of patients with NCP. Recommended first-line topical treatments include neuroregenerative and anti-inflammatory agents, and first-line systemic pharmacotherapy includes tricyclic antidepressants and an anticonvulsant. Second-line oral treatments recommended include an opioid-antagonist and opiate analgesics. Complementary and alternative treatments, such as cardiovascular exercise, acupuncture, omega-3 fatty acid supplementation, and gluten-free diet, may have additional benefits, as do potential noninvasive and invasive procedures in recalcitrant cases. Medication selection should be tailored on an individual basis, considering side effects, comorbidities, and levels of peripheral and centralized pain. Nevertheless, there is an urgent need for long-term studies and RCTs assessing the efficacy of treatments for NCP.
Corneal pain without stain: is it real? [2022]Clinicians often encounter patients who report corneal pain suggestive of dry eye disease, yet lack equivalent signs. These patients represent a diagnostic and therapeutic challenge that is more easily dismissed than addressed. We review the physiology of pain and the pathophysiological mechanisms of neuropathic corneal pain and speculate on the mechanisms of certain etiopathogenic triggers, such as LASIK, severe dry eye disease, and Sjogren syndrome. Recognizing corneal neuropathic pain as a disease in its own right is the first step toward developing more effective treatments for these severely disabled and presently inadequately served patients.
Effects of Mirogabalin on Hyperalgesia and Chronic Ocular Pain in Tear-Deficient Dry-Eye Rats. [2023]Patients with dry eye disease (DED) sometimes complain of ocular pain. DED-related ocular pain has many similarities with neuropathic pain. Mirogabalin, a novel ligand for the α2δ subunit of voltage-gated calcium channels, is approved for treating neuropathic pain in Japan. This study aimed to investigate the effect of mirogabalin on hyperalgesia and chronic ocular pain in a rat DED model.
Successful reversal of neuropathic eye pain by treatment of occult ocular surface disease: Case series and implications. [2022]To report the successful approach to managing neuropathic dry eye-like pain (NP) in three consecutive patients described as severe: 1) "burning fire," "burning acid," and "horrible burning pain" with hyperalgesia and allodynia, 2) refractory to topical anesthetic (TA), and 3) without surface hyperemia nor vital staining.
Topical Therapeutic Options in Corneal Neuropathic Pain. [2022]Purpose of Review: Corneal neuropathic pain can be difficult to treat, particularly due to its lack of response to standard dry eye therapies. We describe a variety of topical therapeutic options that are available to treat corneal neuropathic pain with a significant or primary peripheral component. We also describe possible mechanisms of action for such topical therapies. Recent Findings: Topical corticosteroids and blood-derived tear preparations can be helpful. Newer therapies, including topical lacosamide and low-dose naltrexone are emerging therapeutic options that may also be considered. Summary: Corneal neuropathic pain with a significant peripheral component may be managed with a variety of topical therapeutic options.