Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye

University of Seville30 enrolled

Overview

The objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single-blind clinical trial has been designed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye

Interventions

Icross tear substituteDRUG

Patients were instructed to instill 1 drop of 0.20% Cross-linked hyaluronic acid substitute into each eye 3 times per day for 3 months.

Hyabak tear substituteDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Self-reported history DED. 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.

Locations (1)

Novovision ophthalmologic clinic

Murcia, Spain

Outcomes

Primary Outcomes

Lipid layer thickness (LLT)

The Lipiview® (Johnson \& JohsonVision Care, San Francisco, CA, USA) II ocular surface interferometer evaluates LLT automatically assesses LLT with nanometer precision by recording a 20 s video of the tear film interference pattern and then displays the data in interferometric color units (ICU), where1 ICU reflects approximately 1 nm of LLT.

Time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.

Secondary Outcomes

Ocular surface disease index questionnaire

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.

Time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.

Non-invasive tear film break-up time

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.

Time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.

Schirmer I test without anesthesia

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.

Time frame: This outcome measure was analyzed at baseline, 1 months and 3 months.

Data from ClinicalTrials.gov

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