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NOT YET RECRUITING

NCT07901647

PHASE4

Evaporative Dry Eye

Sponsor: Southern College of Optometry

View on ClinicalTrials.gov

Summary

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

Official title: Investigating Acoltremon 0.003% as an Evaporative Dry Eye Disease Treatment

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-26

Completion Date

2027-08-01

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Dry Eye Evaporative Dry Eye Evaporative Dry Eye Disease

Interventions

DRUG

acoltremon 0.003%.

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).

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 acuity of 20/40 or better. 6. Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study. Exclusion Criteria: * 1\. Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome). 2\. Have a history of ocular surgery within the past 6 months. 3. Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related. 4\. Punctal plugs in place for \<3 months and/or Lacrifill in place for \>5 months. 5\. Use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical glaucoma medication within the previous 30 days screening and during the study period. 6\. Use of artificial tears within 24 hours of screening and during the study period. 7\. Use of contact lenses within 30 days prior to screening and during the study period. 8\. Are pregnant or breast feeding. 9. Have had a physical meibomian gland treatment withing 1 month of enrollment. 10. Initiated, discontinued, or changed dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) within 14 days of the screening visit. 11\. 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.

Locations (1)

The Southern College of Optometry

Memphis, Tennessee, United States