Acoltremon for Dry Eye Syndrome

(AURORA Trial)

ML
SS
Overseen BySusan Sherouse
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of South Florida
Must be taking: Artificial tears
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

PH

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

I have had nerve-related eye pain for at least 3 months, rated 4 or higher in severity.
I had at least 50% pain relief after using proparacaine eye drops.
Baseline unanesthetized Schirmer test ≥2 and < 10 mm
See 3 more

Exclusion Criteria

Drug addiction or alcohol abuse within the last year
I do not have any active eye infections or inflammation inside my eyes.
I cannot stop using my topical medications or varenicline before the trial starts.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants administer acoltremon 0.003% in both eyes twice daily for 8 weeks

8 weeks
Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Acoltremon GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Alcon Research

Industry Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

Alcon Receives FDA Approval of Tryptyr for the Treatment ...

In clinical trials, the most common adverse reaction was instillation site pain (50%).

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 ...

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 ...