Acoltremon for Dry Eye
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
This trial is for people with evaporative dry eye disease. Participants should have symptoms of dry eyes and be able to complete vision tests and questionnaires. Specific inclusion or exclusion criteria are not detailed, but generally, those with active eye infections or other serious eye conditions may not qualify.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- acoltremon 0.003%
Trial Overview
The study is testing acoltremon 0.003% eye drops in all participants to see how it affects signs and symptoms of evaporative dry eye over one month. Everyone receives the same treatment, and changes in tear production and dryness will be measured.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will receive the study drug and be instructed on how to dose properly; however the bottles will be deidentified, and they will not know the product they are using to prevent biasing.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Southern College of Optometry
Lead Sponsor
Alcon Research
Industry Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California
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