Investigator Initiated Trial Using Dry Eye Surveys to Evaluate and Better Understand FDA Approved Acoltremon Treatment for Dry Eye Disease in Real World Treatment Settings (DESERT)

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter for Sight Las Vegas

About this trial

Dry eye disease (DED) is a common, chronic and multifactorial disease of the ocular surface presenting with signs and symptoms of ocular discomfort, visual disturbance and fluctuation, tear film instability, ocular surface inflammation and damage.

It significantly affects patients' quality of life and is one of the most frequent reasons for visits to eye care providers. Many patients remain symptomatic in real-world settings despite current pharmacologic therapeutic options available. As symptoms often lag behind ocular signs, a 3 month study with multiple time points has been designed to assess short term and mid-term symptomatic changes.

This study will use Dry Eye Surveys to evaluate Acoltremon in Real World Settings to help understand its real world effectiveness and potential to improve symptoms in dry eye patients.

Eligibility criteria

Qualifiers

Male or female adults age 18 and older at Visit 1

Have a previous history of dry eye disease, clinician diagnosed or self-reported, for at least 3 months

Total SPEED score ≥ 6 on SPEED questionnaire at Visit 1 Screening & Baseline

Disqualifiers

History of ocular surgery (excluding LASIK or PRK) in the past 3 months

History of LASIK or PRK in the past 12 months

Initiation, discontinuation or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to Visit 1 or a change in dosage is anticipated during the study.

Active ocular infection or inflammation unrelated to dry eye disease (e.g., uveitis, blepharitis requiring antibiotics).

Trial design

Treatments tested in this trial

  • acoltremon 0.003%

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators