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Not yet recruiting NCT07267299

Switching From Restasis to TRYPTYR

Phase IV Interventional Dry Eye Eye Diseases Chronic Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: acoltremon 0.003%.
Who it may be relevant to
Registry conditions: Dry Eye, Eye Diseases, Chronic Dry Eye. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Switching Participants Treated With Restasis to TRYPTYR

Overview

Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.

Detailed description

Acoltremon 0.003% was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor potential melastatin 8 (TRPM8) agonist for the treatment of DED.9, 10 Acoltremon acts by activating TRPM8 receptors expressed on the neurons of the ophthalmic division of the trigeminal nerve, which is the nerve that innervates the cornea and eyelid.9 This drugs subsequently modulates cold thermoreceptor to increase tear production and promote a cooling sensation, which promotes symptomatic relief. While acoltremon 0.003% has been significantly shown to improve the signs and symptoms of DED patient, the community currently lacks data describing how patients who are being treated with Restasis (cyclosporine ophthalmic emulsion), yet are not having their expectations met with the drug, respond to being switched to acoltremon 0.003%. These data are important because they could demonstrate that a DED drug with a different mechanism of action can still be effective when another treatment does not meet the patient's expectations. Thus, the purpose of this study is to determine if acoltremon 0.003% can significantly improve the signs and symptoms of DED suffers who are not currently being successfully treated with Restasis.

Interventions

  • Drug acoltremon 0.003%
    Participants who are using restasis will be switched to acoltremon 0.003%

Primary outcome measures

  • Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1 [Time frame: 1 day]
Secondary outcome measures (2)
  • Change in SPEED scores [Time frame: 28 days]
  • Change in SPEED scores [Time frame: 14 days]

Eligibility criteria

Inclusion 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 effectiveness 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.

Exclusion criteria

  • 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 < 3 months and/or Lacrifill 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07267299 · IRB00006763-Restasis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗