Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation

NCT07245836 | Completed Phase 4

• 1 other identifier: LT2769-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests beside of restoring the tear film by administering topical lubricants, breaking the vicious circle of inflammation is an important mainstay of therapy in patients with DED. Recently, a new medical device (Thealoz Total® eye drops) has been introduced for the treatment DED. Thealoz Total® eye drops are based on hyaluronic acid and exert their main action by lubricating the ocular surface. Further, this new formulation offers several advantages that make them potentially interesting to reduce DED related symptoms. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. thereby reducing signs and symptoms related to DED. Secondly, in addition to the lubricating effect of hyaluronic acid, Thealoz Total eye drops also contain trehalose, which exerts osmoprotetive effects and N-Acetyl Aspartyl Glutamic Acid (NAAGA). NAAGA is an amino conjugated dipeptide with anti-inflammatory properties. Thus, it is reasonable to hypothesize that Thealoz total eye drops are also capable of reducing ocular surface inflammation. The aim of the present study is to investigate whether topical administration with Thealoz Total® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED.

Conditions

Dry Eye Disease (DED)

Keywords

Dry eye disease (DED)

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction assessed by a VAS

  Patient satisfaction assessed by a Visual Analogue Scale (VAS) (min 0 - max 100) The VAS consists of a 10cm line, with two end points representing 0 ('no symptoms') and 100 ('max symptoms')

  week 12

• Conjunctival hyperemia grading with Photographs (Efron) scale at week 12

  Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 The Efron Scale is a clinical grading scale used to assess conjunctival hyperemia. It provides a standardized visual grading from 0 to 4 Grade 0 = normal Grade 1 = trace / very mild Grade 2 = mild to moderate Grade 3 = moderate to severe Grade 4 = severe

  week 12

Secondary Outcomes (9)

• Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale

  week 6 and 12

• Changes from baseline in corneal fluorescein staining according to the Oxford Scale

  week 6 and 12

• Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0%

  week 6 and 12

• Changes from baseline in Schirmer I test using Schirmer paper strips

  week 6 and 12

• Changes from baseline in conjunctival hyperaemia assessment using Mc Monnies photographic scale

  week 6 and 12

Other Outcomes (2)

• Adverse events

  Week 0 - 12

• Best corrected distance visual acuity.

  Week 0 - 12

Study Arms (1)

Thealoz Total® eye drops

EXPERIMENTAL

Thealoz Total® eye drops; 3-6 Drops per day for 12 weeks

Drug: Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, France

Interventions

Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, France DRUG

topical lubrication

Thealoz Total® eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Normal ophthalmic findings except dry eye disease
• Chronic dry eye defined as longer than six months since diagnosis
• OSDI ≥ 22
• Conjunctival Hyperemia≥ Grade 3 (Efron Scale)
• Current use of topical lubricants since at least 3 months

You may not qualify if:

• \- Best far corrected visual acuity \< 1/10
• Severe Dry Eye associated with:
• Eyelid malposition
• Stevens Johnson Syndrome
• Corneal dystrophy
• Ocular neoplasia
• Filamentous keratitis
• Corneal neovascularisation
• Orbital radiotherapy
• Dry eye related to GVHD
• History of any of the following within last 3 months:
• Systemic treatment of dry eye
• Systemic treatment of MGD
• Isotretinoïde,
• Cyclosporine,

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. Doz. Dr., PhD

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 24, 2025
• Study Start: January 20, 2025
• Primary Completion: June 3, 2025
• Study Completion: July 6, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)