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Completed

NCT Number: NCT06478134

Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Novovision ophthalmologic clinic

Murcia, 30009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-reported history DED while working with computer screens ≥ 6 hours per day.
  • ocular surface disease index (OSDI) > 13 points.
  • non-invasive tear film break-up time (NIBUT) < 10 s.
  • Schirmer test (ST) without anesthesia ≥ 5 mm.
  • 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

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

Treatment and study plan

Trimix tear substitutes

Drug

Patients were instructed to instill 1 drop of TriMix tear substitute into each eye 3 times per day for 6 months.

Hyaluronic acid tear substitute

Drug

Patients were instructed to instill 1 drop of 0.15% HA tear substitute into each eye 3 times per day for 6 months.

Primary outcomes

  1. Ocular surface disease index questionnaire

    Time frame: This outcome measure was analyzed at baseline, 3 months and 6 months.

    The OSDI questionnaire were employed to assess the severity of DED symptoms, with scores ranging from 0 (indicating no ocular surface disease) to 100 (indicating severe ocular surface disease) points. This questionnaire was provided during consultations at each follow-up visit.

  2. Non-invasive tear film break-up time

    Time frame: This outcome measure was analyzed at baseline, 3 months and 6 months.

    Tear film stability was automatically assessed using NIBUT by projecting Placido rings from the Sirius device (CSO, Florence, Italy) onto the corneal surface. The time interval between the last blink and the initial distortion of the ring pattern was defined as first NIBUT. This variable was always measured at least 12 hours after administration of the study medication and the average of 3 consecutive measurements was calculated for statistical analysis.

  3. Schirmer I test without anesthesia

    Time frame: This outcome measure was analyzed at baseline, 3 months and 6 months.

    During the test, the patient is instructed to look upward while the test strip is carefully positioned between the palpebral conjunctiva of the lower eyelid and the bulbar conjunctiva. Subsequently, the patient is asked to keep their eyes gently closed for five minutes. After this period, the test strip is removed, and the Schirmer test score is determined by measuring the length of the moistened area on the strip.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease: A Randomized, Double-blinded, HA-controlled Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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