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3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis

A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study in Adult Patients With Moderate to Severe Dry Eye Disease Related to Keratitis or Keratoconjunctivitis

NCT04685109•Santen SAS

View on ClinicalTrials.gov

Summary

This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is conducted at a national level, in France. The patients will be randomised to receive ALOCROSS® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion

Detailed Description

Primary: • To compare the ocular efficacy of ALOCROSS® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis after a 4-week treatment period (Day 28). Secondary: * To compare the ocular efficacy of ALOCROSS® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis over a 12-week treatment period * To evaluate the ocular tolerability and safety of ALOCROSS® versus VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis throughout the duration of treatment

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient eligibility is determined according to the following criteria:
•1. Male or female patient aged 18 years or above.
•2. Patient using artificial tears for at least 3 months prior to the Screening visit.
•3. Patient experiencing at least 2 symptoms of ocular discomfort rated ≥23 mm on the 0 to 100 mm visual analogue scale (VAS) (among itching, eye dryness, sticky feeling, photophobia, pain, burning or stinging, sandy feeling or grittiness, or foreign body sensation) at Screening and Baseline visits.
•4. OSS score (sum of nasal and temporal interpalpebral conjunctival and corneal vital staining) ≥4 and ≤9 on a modified Oxford scale at Screening and Baseline visits in at least one eye.
•6. The patient has signed and dated a written informed consent form prior to the initiation of any study procedures.

Exclusion Criteria

•Any patient who meets any of the following criteria (in any eye) will not qualify for entry into the study:
•Ocular
•1. CFS score ≥4 on a modified Oxford scale
•2. Ocular hypertension or glaucoma requiring IOP-lowering medication(s)
•3. History of ocular trauma, infection or ocular inflammatory condition within the last 3 months before the screening visit.
•4. Severe blepharitis and/or severe meibomian gland disease
•5. Filamentary keratitis
•6. Any ocular surface anomaly not related to DED
•7. Active ocular infection or history of ocular allergy or ocular herpes
•8. Patient with only one sighted eye or with a best corrected distance visual acuity ≤1/10
+15 more criteria

Locations (6)

Chru Brest Hopital Morvan

Brest, France

Cabinet Liberal

La Rochefoucauld, France

Hopital Edouard Herriot - Pavillon C

Lyon, France

Institut Ophtalmologique Ouest Jules Verne

Nantes, France

Hopital Necker - Ophtalmologie

Paris, France

Hopitaux Universitaires Paris-Sud - Hopital Bicetre

Le Kremlin-Bicêtre, Île-de-France Region, France

Key Dates

Start Date

May 11, 2021

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

May 21, 2025

Enrollment

ESTIMATED participants

Conditions

Dry Eye Syndromes

Interventions

Alocross 0.2% Unit Dose

DEVICE

Vismed

DEVICE

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis

Inclusion Criteria

Exclusion Criteria

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