Clinical trial NCT06478134: Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease
Official title: Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease: A Randomized, Double-blinded, HA-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were instructed to instill 1 drop TriMix tear substitute or 0.15% HA tear substitute into each eye 3 times per day for 6 months. HA-based tear substitutes can reduce tear film hyperosmolarity and are effective in treating DED. Therefore, 0.15% HA tear substitute was selected as a suitable comparator.
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the efficacy and safety of TriMix tear substitute in patients with dry eye disease. For this purpose, a randomized, double-blind clinical trial has been designed, using an Hyaluronic acid-based tear substitute as a control.


Eligibility criteria: Inclusion Criteria:

1. Self-reported history DED while working with computer screens ≥ 6 hours per day.
2. ocular surface disease index (OSDI) \> 13 points.
3. non-invasive tear film break-up time (NIBUT) \< 10 s.
4. Schirmer test (ST) without anesthesia ≥ 5 mm.
5. MGD grade ≤ 1. For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG \< 25%; MGD grade 2 = LAMG ≥ 25% and \< 50%; MGD grade 3 = LAMG ≥ 50% and \< 75%; MGD grade 4 = LAMG ≥ 75%).

Exclusion Criteria:

1. abnormal lid anatomy, including active blepharitis, and active lid margin.
2. all corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
3. active ocular allergies.
4. vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
5. intraocular surgery or laser ocular surgery within the previous 6 months.
6. use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
7. systemic autoimmune diseases.
8. contact lens wearers.
9. pregnant or lactating women.
10. patients who did not understand or comprehend the informed consent.

Primary outcomes:
measure: Ocular surface disease index questionnaire
timeFrame: This outcome measure was analyzed at baseline, 3 months and 6 months.
measure: Non-invasive tear film break-up time
timeFrame: This outcome measure was analyzed at baseline, 3 months and 6 months.
measure: Schirmer I test without anesthesia
timeFrame: This outcome measure was analyzed at baseline, 3 months and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Novovision ophthalmologic clinic
Study officials:
affiliation: University of Seville
name: José-María Sánchez-González
role: STUDY_DIRECTOR
References:
citation: Vigo L, Senni C, Pellegrini M, Vagge A, Ferro Desideri L, Carones F, Scorcia V, Giannaccare G. Effects of a New Formulation of Multiple-Action Tear Substitute on Objective Ocular Surface Parameters and Ocular Discomfort Symptoms in Patients with Dry Eye Disease. Ophthalmol Ther. 2022 Aug;11(4):1441-1447. doi: 10.1007/s40123-022-00518-7. Epub 2022 May 14.
citation: Roszkowska AM, Inferrera L, Spinella R, Postorino EI, Gargano R, Oliverio GW, Aragona P. Clinical Efficacy, Tolerability and Safety of a New Multiple-Action Eyedrop in Subjects with Moderate to Severe Dry Eye. J Clin Med. 2022 Nov 26;11(23):6975. doi: 10.3390/jcm11236975.