Long-term Effects of Acoltremon vs. Control in Dry Eye Disease

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
The Eye Care Institute
Study ID
NCT07659626
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acoltremon 0.003% — DRUG
    acoltremon 0.003%
  • Refresh classic preservative free — DRUG
    Refresh classic preservative free (control)

Study Details

This is a prospective, longitudinal, single-center study designed to evaluate the long-term changes in symptoms and tear production in subjects with dry eye disease. The study is randomized and investigator-masked, with subjects assigned to either the TRYPTYR (Acoltremon ophthalmic solution 0.003%) arm or the control arm (Refresh Classic Preservative-free). The study will be conducted at a single site, with subjects undergoing assessments at baseline and at months 1, 3, 6, 9, and 12.

Key Dates

Start date
Jul 20, 2026
Status verified
Jun 2026
Primary completion
Jul 20, 2027
Completion
Jul 20, 2029

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Acoltremon 0.003%
  • Arm: Control
    Refresh Classic Preservative free

Primary Outcome Measure

Mean change from baseline in ODS-VAS [ Time Frame: 12 months post-treatment initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Butchertown Clinical TrialsLouisvilleKentucky40206
Dani Gulock
[email protected]
502-219-7700
Guruprasad Pattar, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Butchertown Clinical Trials· Louisville, KY

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