Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT07281950
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* Severe ocular surface disease or damage (e.g., corneal ulcers, neurotrophic keratopathy).
* Have had a corneal transplant in either or both eyes.
* Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study and unwilling to discontinue use during the duration of the study.
* Known allergy or hypersensitivity to acoltremon or formulation ingredients.
* Current pregnancy or breastfeeding
* Women of childbearing potential who are not using an acceptable means of contraception. Acceptable means of contraception include hormonal contraceptives (i.e. oral, implantable, injectable, or transdermal contraceptives, with a barrier such as a diaphragm or a condom) or intrauterine devices. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07281950
Study Brief:
Protocol Section:
NCT07281950