← Back to all trials
Not Yet Recruiting
NCT07888452
Cooling Eyedrops for Dry Eye
Conditions: Dry Eye
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 50
Sponsor: University of California, Berkeley
Location: U.C. Berkeley Clinical Research Center Berkeley California
Summary
In dry eye (DE), either insufficient aqueous tears are produced or the tears evaporate off the ocular surface too quickly. Meibomian gland dysfunction (MGD) results in poor quality or insufficient meibum being expressed during blinking, leading to a thinner tear lipid layer and faster aqueous tear evaporation. MGD is a major factor in evaporative dry eye globally. Activation of TRPM8 receptors on the cornea and eyelid margins gives a cooling sensation, which may increase the basal production of both aqueous tears and meibum through parasympathetic neural circuitry. The investigators hypothesize that acoltremon (TRYPTYR) 0.003% eye drops can increase tear lipid layer thickness and reduce the tear thinning rate.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Best corrected visual acuity 20/25 or better in each eye
* Diagnosis of evaporative dry eye disease within the last 6 months
* Able to understand and sign informed consent
* Able and willing to comply with visit schedule
* Able and willing to undergo all planned assessments
* Baseline LipiView tear lipid layer thickness ≤50nm
Exclusion Criteria:
* Subjects with a condition or in a situation which, in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study
* Use of contact lenses within 24 hours of study
* Use of OTC eye drops or ocular medications within 24 hours of study
* Currently using any prescription topical eye medication
* Having known systemic health conditions that might alter tear film physiology
* Having a history of viral eye disease
* Having a history of diabetes
* Having a history of ocular surgery
* Having a history of severe ocular trauma
* Having an active ocular infection or inflammation
* Currently using isotretinoin-derivatives
* Pregnant or breastfeeding
* Taking antihistamines, antianxiety agents, antidepressants, antimuscarinics, or any other drug known to cause or exacerbate dry eye
* Having lid margin inflammation or erythema
* Having visible capped meibomian glands
* Having collarettes or signs of demodex blepharitis
Source: ClinicalTrials.gov (NCT07888452). StuddyBuddy aggregates publicly available trial information.