AR-15512 for Dry Eye Syndrome
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Alcon Research
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using topical medications for other significant eye diseases, you may not be eligible to participate.
What data supports the idea that AR-15512 for Dry Eye Syndrome is an effective treatment?
The available research shows that AR-15512 was evaluated in a study called COMET-1, which was a randomized trial. This means participants were randomly assigned to receive either AR-15512 or a placebo, which is a substance with no active drug. The study focused on how well AR-15512 worked for people with Dry Eye Syndrome. Although the specific results are not detailed in the provided information, the fact that it was tested in a controlled study suggests that researchers are investigating its effectiveness as a treatment for Dry Eye Syndrome.
12345What safety data is available for AR-15512 in treating dry eye syndrome?
The safety data for AR-15512 in treating dry eye syndrome is available from a Phase 2b study (COMET-1) that evaluated two concentrations of AR-15512, a TRPM8 receptor agonist, for dry eye disease. This study was randomized and vehicle-controlled, indicating a structured approach to assessing safety and efficacy.
16789Eligibility Criteria
This trial is for individuals with dry eye disease. Participants should have a diagnosis of dry eye syndrome and be willing to follow the study procedures. Specific eligibility criteria are not provided, but typically include age limits, symptom severity, and no recent use of conflicting medications or treatments.Inclusion Criteria
Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history
Other protocol specified inclusion criteria may apply
I have been diagnosed with or reported dry eye disease in the last 6 months.
+2 more
Exclusion Criteria
I do not have any eye diseases that need drops or could affect the study.
I regularly use lid hygiene or heat masks and plan to continue during the study.
I haven't had any lid heating or Meibomian gland treatments in the last year.
+4 more
Participant Groups
The study is testing the effectiveness of a new ophthalmic solution called AR-15512 at a concentration of 0.003%. It's being compared against artificial tears, which are commonly used to manage symptoms of dry eye disease.
2Treatment groups
Experimental Treatment
Active Control
Group I: 0.003% AR-15512Experimental Treatment1 Intervention
One drop in each eye twice daily for 90 days (treatment period)
Group II: Artificial TearsActive Control1 Intervention
One drop in each eye twice daily for 90 days (treatment period)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Contact Alcon Call Center for Trial LocationsFort Worth, TX
Oculus ResearchGarner, NC
Wilmington EyeLeland, NC
CORE, Inc.Shelby, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Alcon ResearchLead Sponsor
References
A randomized, vehicle-controlled, Phase 2b study of two concentrations of the TRPM8 receptor agonist AR-15512 in the treatment of dry eye disease (COMET-1). [2022]Dry eye disease (DED) symptoms can negatively impact quality of life (QoL). AR-15512, a transient receptor potential melastatin 8 (TRPM8) agonist, was evaluated as a potential therapy for DED.
Prevalence and risk factors of dry eye syndrome in a United States veterans affairs population. [2022]To evaluate the prevalence of dry eye syndrome (DES) and its associated risk factors in a US Veterans Affairs population receiving ocular care services.
Changes in dry eye diagnostic status following implementation of revised Japanese dry eye diagnostic criteria. [2021]Our aim was to evaluate changes in dry eye diagnostic status following implementation of the new dry eye diagnostic criteria in Japan.
New testing options for diagnosing and grading dry eye disease. [2022]To describe new options for diagnosis and severity grading of dry eye disease.
Changes in Distribution of Dry Eye Disease by the New 2016 Diagnostic Criteria from the Asia Dry Eye Society. [2019]Dry eye disease (DED) is a disorder of the tear film. Here, we delineate the changes in distribution of DED after diagnostic criteria changes from the 2006 Japanese Diagnostic Criteria to the 2016 Asia Dry Eye Society criteria. We included 250 right eyes of 250 patients and all patients completed ophthalmic assessments for DED. The 2006 criteria classified patients into definite DED, probable DED, and non-DED based on subjective symptoms, tear function, and/or vital staining. The 2016 criteria eliminated probable DED and classified patients into definite DED or non-DED based on subjective symptoms and decreased tear break-up time. We examined how probable DED patients were reclassified by the 2016 criteria. By the 2006 criteria, 38.8% (97/250) of patients had definite DED, 35.6% (89/250) had probable DED, and 25.6% (64/250) had non-DED. By the 2016 criteria, 66.8% (167/250) had definite DED and 31.2% (83/250) had non-DED. Among patients with probable DED using the 2006 criteria, 79.8% (71/89) were reclassified as definite DED and 20.2% (18/89) were reclassified as non-DED using the 2016 criteria. Our data revealed that prevalence of definite DED increased because most probable DED patients were reclassified as definite DED after changes in the diagnostic criteria.
Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of SA001 and Its Active Metabolite Rebamipide after Single and Multiple Oral Administration. [2023]Dry eye disease (DED) is one of the most common eye diseases caused by multiple factors. Rebamipide, which is currently used to treat peptic ulcer disease, was shown to enhance secretory function and modulate inflammation in animal disease models. Considering the pathophysiology of DED, SA001 was developed expecting enhanced systemic exposure of rebamipide. Clinical trials to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of SA001 and its active metabolite rebamipide were conducted. After oral administration of SA001, blood and urine samples were collected for PK analysis of SA001 and rebamipide. PK parameters were compared between SA001 and conventional rebamipide (Bamedin®) and also between fasted and fed. Safety and tolerability were evaluated throughout the study based on adverse events (AEs), physical examinations, vital signs, 12-lead electrocardiography and clinical laboratory tests. SA001 was rapidly absorbed and quickly converted to rebamipide. The systemic exposure of rebamipide was dose-proportional after single and multiple doses. The plasma concentration of rebamipide after administration of SA001 was higher with a dose adjusted AUClast and Cmax 2.20 and 5.45 times higher in the 240 mg dose group and 4.73 and 11.94 times higher in the 600 mg dose group compared to conventional rebamipide. The favorable PK and tolerability profiles support further clinical development.
TFOS DEWS II iatrogenic report. [2022]Dry eye can be caused by a variety of iatrogenic interventions. The increasing number of patients looking for eye care or cosmetic procedures involving the eyes, together with a better understanding of the pathophysiological mechanisms of dry eye disease (DED), have led to the need for a specific report about iatrogenic dry eye within the TFOS DEWS II. Topical medications can cause DED due to their allergic, toxic and immuno-inflammatory effects on the ocular surface. Preservatives, such as benzalkonium chloride, may further aggravate DED. A variety of systemic drugs can also induce DED secondary to multiple mechanisms. Moreover, the use of contact lens induces or is associated with DED. However, one of the most emblematic situations is DED caused by surgical procedures such as corneal refractive surgery as in laser-assisted in situ keratomileusis (LASIK) and keratoplasty due to mechanisms intrinsic to the procedure (i.e. corneal nerve cutting) or even by the use of postoperative topical drugs. Cataract surgery, lid surgeries, botulinum toxin application and cosmetic procedures are also considered risk factors to iatrogenic DED, which can cause patient dissatisfaction, visual disturbance and poor surgical outcomes. This report also presents future directions to address iatrogenic DED, including the need for more in-depth epidemiological studies about the risk factors, development of less toxic medications and preservatives, as well as new techniques for less invasive eye surgeries. Novel research into detection of early dry eye prior to surgeries, efforts to establish appropriate therapeutics and a greater attempt to regulate and oversee medications, preservatives and procedures should be considered.
OC-01 (Varenicline Solution) Nasal Spray Demonstrates Consistency of Effect Regardless of Age, Race, Ethnicity, and Artificial Tear Use. [2022]To evaluate OC-01 [varenicline solution nasal spray (VNS)] tear production and symptom outcomes in patients with dry eye disease by age, gender, race, ethnicity, and artificial tear use status.
Ocular Surface Ion-Channels Are Closely Related to Dry Eye: Key Research Focus on Innovative Drugs for Dry Eye. [2022]Abundant ion-channels, including various perceptual receptors, chloride channels, purinergic receptor channels, and water channels that exist on the ocular surface, play an important role in the pathogenesis of dry eye. Channel-targeting activators or inhibitor compounds, which have shown positive effects in in vivo and in vitro experiments, have become the focus of the dry eye drug research and development, and individual compounds have been applied in clinical experimental treatment. This review summarized various types of ion-channels on the ocular surface related to dry eye, their basic functions, and spatial distribution, and discussed basic and clinical research results of various channel receptor regulatory compounds. Therefore, further elucidating the relationship between ion-channels and dry eye will warrant research of dry eye targeted drug therapy.
[Lack of concordance between dry eye syndrome questionnaires and diagnostic tests]. [2019]To report the prevalence of dry eye syndrome (DES) in a subset of patients > 50 years old in Valladolid, Spain, calculate internal validity of two DES screening questionnaires, and correlate the results with DES diagnostic tests.
Prevalence of and risk factors for symptomatic dry eye disease in Singapore. [2015]The aim of this study was to describe the prevalence and risk factors of symptomatic dry eye disease (SDED) in Singapore.
Heterogeneity of eye drop use among symptomatic dry eye individuals in Japan: large-scale crowdsourced research using DryEyeRhythm application. [2021]To determine eye drop type and usage frequency and investigate risk factors for no eye drop use in individuals with symptomatic dry eye (DE) in Japan.