Acoltremon for Dry Eye Syndrome
(AURORA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how well a new eye drop, acoltremon ophthalmic solution 0.003%, aids individuals with dry eye syndrome and neuropathic corneal pain (eye pain related to nerve issues). The eye drop activates specific receptors in the eyes to boost natural tear production and potentially reduce pain and discomfort. The trial spans 8 weeks, with participants using the drops twice daily to assess symptom improvement. It suits those who have experienced dry eyes and related pain for at least 3 months, with symptoms like burning or stinging. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits a broader range of patients.
What is the safety track record for acoltremon ophthalmic solution?
Research has shown that acoltremon eye drops 0.003% are generally well-tolerated. Clinical trials reported that the most common side effect was pain at the application site, occurring in about 50% of participants. This indicates that half of the users experienced some discomfort. However, no serious side effects emerged, suggesting the treatment is relatively safe. The FDA has already approved acoltremon for treating dry eye disease, further supporting its safety.12345
Why are researchers enthusiastic about this study treatment?
Acoltremon is unique because it offers a new approach to treating Dry Eye Syndrome with its specific formulation as an ophthalmic solution. Unlike the current standard treatments, such as artificial tears and anti-inflammatory drops like cyclosporine, acoltremon works by delivering a precise concentration of 0.003% directly to the eye, potentially enhancing effectiveness. Researchers are excited about acoltremon because it might provide relief more efficiently and with fewer side effects, offering a promising new option for those who haven't found success with existing therapies.
What is the effectiveness track record for acoltremon in treating dry eye syndrome?
Research shows that acoltremon eye drops, used by participants in this trial, can help people with dry eye syndrome by increasing tear production. Studies have found that these drops activate certain receptors in the eyes, which aid in producing natural tears. This process is crucial for treating dry eyes. Early research also suggests that acoltremon might reduce eye pain, enhancing comfort. With the treatment already approved, strong evidence supports its effectiveness in boosting tear production.
Who Is on the Research Team?
Pedram Hamrah, MD
Principal Investigator
University of South Florida/Ophthalmology
Are You a Good Fit for This Trial?
This trial is for people who have both dry eye (tear deficiency) and nerve-related eye pain. Participants should not have other major eye diseases or conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants administer acoltremon 0.003% in both eyes twice daily for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- acoltremon ophthalmic solution 0.003%
Trial Overview
The study tests acoltremon ophthalmic solution 0.003%, an eye drop designed to boost natural tear production and reduce nerve-related eye pain, over an 8-week period in people with dry eyes and neuropathic corneal pain.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will administer one drop of Acoltremon Ophthalmic Solution 0.003% twice a day for 8 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor
Alcon Research
Industry Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California
Citations
1.
eyewire.news
eyewire.news/news/alcon-receives-fda-approval-of-tryptyr-for-the-treatment-of-the-signs-and-symptoms-of-dry-eye-diseaseAlcon Receives FDA Approval of Tryptyr for the Treatment ...
In clinical trials, the most common adverse reaction was instillation site pain (50%).
2.
ophthalmology360.com
ophthalmology360.com/dry-eye/acoltremon-0-003-induces-normal-tear-production-in-patients-with-dry-eye-disease/Acoltremon 0.003% induces normal tear production in patients ...
The results met the primary endpoint, which was the percentage of subjects who showed a greater than 10-mm increase in Schirmer's scores after ...
Meet TRYPTYR (acoltremon ophthalmic solution) 0.003%
It includes important safety warnings, such as avoiding eye surfaces and contact lenses, and directs viewers to the Alcon website for full ...
4.
alconscience.com
alconscience.com/resource/acoltremon-ophthalmic-solution-0003-signs-and-symptoms-dry-eye-disease-results-phase-3/Results of Phase 3 Pivotal Studies COMET-2 and COMET-3
acoltremon ophthalmic solution 0.003% demonstrated statistically significant increases in tear production compared to vehicle on Day 14. Effects were rapid ( ...
Document
TRYPTYR (acoltremon ophthalmic solution) 0.003% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). IMPORTANT ...
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