Acoltremon for Dry Eye

CL
QX
Overseen ByQuentin X Franklin, BS, BA
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Southern College of Optometry
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

Has DED in the study eye as determined by 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 qualifies one eye, that is the study eye; if both eyes qualify, the eye with the lower Schirmer score is the study eye
I am 18 years old or older.
I have had dry eye disease for at least 6 months.
See 3 more

Exclusion Criteria

Punctal plugs in place for less than 3 months and/or Lacrifill in place for more than 5 months
I use artificial tears daily and will continue during the study.
Use of contact lenses within 30 days prior to screening and during the study
See 8 more

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

Group I: acoltremon 0.003%Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Southern College of Optometry

Lead Sponsor

Trials
8
Recruited
390+

Alcon Research

Industry Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California