Long-term Effects of Acoltremon vs. Control in Dry Eye Disease
ConditionDry Eye
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Eye Care Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, 18 years of age or older at the Screening visit.
Have a previous history of DED, clinician diagnosed, or patient reported, within the previous 6 months prior to the Screening visit.
Have used, and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit.
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.
Disqualifiers
History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety.
Diagnosis of recurrent, ongoing, or active ocular infection.
History of ocular surgery within 1 year prior to the Screening visit.
Have had a corneal transplant in either or both eyes.
Trial population
Subjects aged 18 years or older with a history of dry eye disease (DED) will be randomized.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Acoltremon 0.003%
Drugacoltremon 0.003%
Refresh classic preservative free
DrugRefresh classic preservative free (control)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Acoltremon 0.003%1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
Mean change from baseline in ODS-VAS
Time frame
12 months post-treatment initiationOther outcomes
1
Mean change from baseline in unanesthetized Schirmer's test
Time frame
12 months post-treatment initiation2
Mean change from baseline in unanesthetized Schirmer's test
Time frame
9 months post-treatment initiation3
Mean change from baseline in unanesthetized Schirmer's test
Time frame
6 months post-treatment initiation4
Mean change from baseline in unanesthetized Schirmer's test
Time frame
3 months post-treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Eye Care Institute
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov