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)

NCT07281950 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: CFS-DESERT-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Disease (DED)

Keywords

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• • Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)

  Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)

  Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)

Study Arms (1)

all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon

OTHER

all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon 0.003%

Drug: acoltremon 0.003%

Interventions

acoltremon 0.003% DRUG

single arm

all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• o Note: occasional short-term use of medications such as systemic antihistamines will be permitted provided that use was not within 24 hours of Visit 1 or anticipated use within 24 hours of any study visit.
• Active ocular infection or inflammation unrelated to dry eye disease (e.g., uveitis, blepharitis requiring antibiotics).
• Use of Restasis, Xiidra, Miebo, or any other topical anti-inflammatory medications within 30 days of Visit 1 and for the duration of the study.
• Use of varenicline nasal spray within 30 days of Visit 1 and for the duration of the study.
• Eyelid hygiene (such as "lid scrubs") is allowed but should be continued without change to current regiment at Visit 1 Baseline for the duration of the study.
• Use of other DED medications within 30 days of Visit 1 Baseline Use of artificial tears is allowed but must be preservative free and the dosing should not change from current regiment at Visit 1 Baseline.
• Use of amniotic membranes or serum tears within 90 days of Visit 1 Baseline
• Use of lid heating therapy (i.e., LipiFlow, iLUX, TearCare) within 90 days of Visit 1 Baseline and for the duration of the study.
• Punctal or intracanalicular plug inserted in either eyelid within 90 days prior to Visit 1 Baseline or anticipated plug insertion or occlusion at any time during the study.
• Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension) or other disease the investigator believes may interfere with study findings or interpretation.
• Use of any topical ocular glaucoma medication within 30 days prior to the Screening visit or anticipated use during the study.
• Use of systemic medications that affect tear production (e.g., isotretinoin, antihistamines) unless on stable doses for \> 30 days.

Sponsors & Collaborators

• Center for Sight Las Vegas: lead

Study Sites (1)

Center for Sight

Las Vegas, Nevada, 89128, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Clinical Research Manager

CONTACT

702-724-2005; jodi.kennedy@c4slv.com

Study Coordinator

CONTACT

702-724-2067

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-site, multi-location, single arm study.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)