Dry Eye study: Acoltremon
Official title Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
ClinicalTrials.gov ID: NCT07266948
What this study is testing
What is Acoltremon?
An investigational drug being studied as a potential treatment for dry eye disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the treatment TRYPTYR helps people with dry eye feel better and perform their work tasks more easily.
- Who it's for
- The study is looking for adults 18 or older who have had dry eye for at least 6 months and find it hard to work because of their symptoms.
- What's involved
- Participants will receive the treatment and visit the clinic three times over one month for eye exams and questionnaires about their symptoms and work.
- Time commitment
- The study lasts one month and requires three visits to the clinic.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adults ≥18 years of age.
- Have a history of DED for at least the past 6 months.
- Are currently using Restasis as directed by their eye care provider for ≥1 month.
- Participant intends to stop Restasis in the near future because and expressed dissatisfaction with how well it works of Restasis in reducing dry eye...
- Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score [≥2 to...
You likely can't join if
- Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- Have a history of ocular surgery within the past 12 months.
- Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- Punctal plugs in place for \ 5 months.
- Have ever used Accutane or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry...
- Use of artificial tears within 2 hours prior to the baseline visit or during the study.
See the full eligibility criteria
- Adults ≥18 years of age.
- Have a history of DED for at least the past 6 months.
- Are currently using Restasis as directed by their eye care provider for ≥1 month.
- Participant intends to stop Restasis in the near future because and expressed dissatisfaction with how well it works of Restasis in reducing dry eye symptoms..
- Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score [≥2 to \<10 mm/5 min]) at Screening/Baseline.
- Have corrected distance visual acuity of 20/100 or better.
- Willing to discontinue contact lens wear throughout the study.
- Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- Have a history of ocular surgery within the past 12 months.
- Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- Punctal plugs in place for \ 5 months.
- Have ever used Accutane or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry, except for Restasis).
- Use of artificial tears within 2 hours prior to the baseline visit or during the study.
- Are pregnant or breast feeding.
- Have had a physical meibomian gland treatment withing 1 month of enrollment.
- Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburg, Kansas, United States
- Medina, Minnesota, United States
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburg, Kansas, United States; Medina, Minnesota, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.