Southern College of Optometry
The goal of this clinical trial is to \[primary purpose is to learn if accordingly, the purpose of this study is to evaluate the effects of acoltremon in participants with evaporative DED, with a focus on characterizing how symptoms and evaporative DED signs change over the first month of treatment. \[primary hypothesis or outcome measure 1\] Change in unanesthetized Schirmer test score between pre-drop at baseline compared to post-drop score on Day 1 Researchers will compare all of the enrolled participants, and everyone will be provided the same treatment. Participants will • 2. Eye Dryness VAS: A 0-100 Eye Dryness VAS will be completed by the participants. * 3\. OSDI: The OSDI (0-100) will be completed by the subjects. * 4\. Visual Acuity: The participant's current corrected visual acuity will be measured with a high-contrast, Snellen chart. If the participant is unable to read the 20/40 letters (0.3 logMAR), the investigator will pinhole over the participant's unaided or presenting refractive error correction to determine the participant's visual potential. * 5\. Slit-Lamp Biomicroscopy: The investigator will use a slit-lamp biomicroscope to document normal and/or remarkable findings of the anterior eye structures: eyelashes, eyelids, conjunctiva, and cornea. * Schirmer's Test without Anesthesia (Pre-Drop): Schirmer's I test will be performed on each eye for 5 minutes. The amount of wetting will be measured on each strip. * Drop Application: 15 minutes after the pre-drop Schirmer's Test, one drop of acoltremon 0.003% will be applied to each eye. * Schirmer's Test without Anesthesia (Post-Drop): Schirmer's I test will be performed on each eye for 5 minutes 3 minutes post-drop application. The amount of wetting will be measured on each strip. * Tear Break Up Time (TBUT): TBUT will be determined by instilling sodium fluorescein using a strip wetted with saline (single drop and flicked to remove excess). Testing will start about 1 minute after fluorescein application. An average of three times will be utilized. A stopwatch will be used for timing. * Total Corneal Fluorescein Staining (NEI scale): Sodium fluorescein from TBUT testing will be used to evaluate corneal fluorescein staining. After waiting for about 2-minute, corneal staining will be assessed with a cobalt blue light and a yellow filter. Corneal staining will be graded with the original National Eye Institute (NEI) grading scale; 0-3 score/region (5 regions) with 0-15 score/eye. Meibomian Gland Secretion Score (0-15 scale): The 5 central glands on lower eyelid will be evaluated by the investigator with their finger (each scored 0-3): 0 = normal; 1 = thick/yellow; whitish, particulate; 2 = paste; 3 = none/occluded. The investigator will do their best to grade the same 5 glands each visit
Dry eye disease is a complex and multifactorial condition that impacts a large number of people around the world. Symptoms can often include burning, stinging, soreness or irritation. However clinically it is defined differently which can be described as when patients are experiencing reduced tear production (aqueous-deficient DED), increased tear evaporation (evaporative DED), or both (mixed). While many patients suffer from aqueous-deficient DED, evaporative DED is much more prevalent. Acoltremon 0.003% or TRYPTYR is designed to help stimulate TRPM8 receptors which then coordinates the secre…
Inclusion Criteria: \- 1. Adults ≥18 years of age. 2. Have a history of DED for at least the past 6 months. 3. Has DED as determined by the following in the study eye: TBUT ≤5 seconds plus Schirmer's test ≥5 and ≤20 mm plus a tCFS score ≥4 and ≤11 plus total MGS score ≥3.8 If Schirmer's test only qualifies for one eye, that will be the study eye. If Schirmer's test qualifies for both eyes, the eye with the lower Schirmer score will be the study eye. 4\. Symptomatic as defined by Eye Dryness VAS score of ≥40 plus Ocular Surface Disease Index (OSDI) score ≥25 5. Have corrected distance visual…
this study seeks to address this gap by investigating the short-term impact of acoltremon 0.003% on both symptoms and key clinical markers of evaporative DED, including tear break up time (TBUT).