The Eye Care Institute
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.
Inclusion Criteria: 1. Male or female, 18 years of age or older at the Screening visit. 2. Have a previous history of DED, clinician diagnosed, or patient reported, within the previous 6 months prior to the Screening visit. 3. Have used, and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit. 4. Both of the following signs of DED in the same eye: 1. Total corneal fluorescein staining score of \>= 2 and \<= 10 based on the NEI grading scheme, with no one region scoring \> 3 in at least 1 eye. 2. Unanesthetized Schirmer test score \>= 2 and \…
acoltremon 0.003%
Refresh classic preservative free (control)
Arctuva estimate
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