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Dry Eye SyndromesALHENANCT04685109

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

A study testing Alocross 0.2% Unit Dose and Vismed in people with Dry Eye Syndromes, run by Santen SAS at 6 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Syndromes
What is being tested?
Alocross 0.2% Unit Dose and Vismed
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
6 sitesFrance
Study dates
11 May 2021to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient eligibility is determined according to the following criteria:
  • Male or female patient aged 18 years or above.
  • Patient using artificial tears for at least 3 months prior to the Screening visit.
  • 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.
  • 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.
  • TBUT of ≤10 seconds at Screening and Baseline visits and/or Schirmer's tear test of ≥3 and ≤9 mm/5 min at Screening visit in the same eye that fulfil inclusion criteria #4.
  • The patient has signed and dated a written informed consent form prior to the initiation of any study procedures.

Who cannot join

  • Any patient who meets any of the following criteria (in any eye) will not qualify for entry into the study:
  • Ocular
  • CFS score ≥4 on a modified Oxford scale
  • Ocular hypertension or glaucoma requiring IOP-lowering medication(s)
  • History of ocular trauma, infection or ocular inflammatory condition within the last 3 months before the screening visit.
  • Severe blepharitis and/or severe meibomian gland disease
Show all 25Show fewer
  • Filamentary keratitis
  • Any ocular surface anomaly not related to DED
  • Active ocular infection or history of ocular allergy or ocular herpes
  • Patient with only one sighted eye or with a best corrected distance visual acuity ≤1/10
  • Use of any topical ocular treatment other than study device during the study (all non-study topical ocular treatment(s) must be stopped at the screening visit)
  • Onset of lid hygiene (whatever the method) less than 2 months before the Screening visit
  • Use of topical corticosteroids one month before the Screening Visit
  • Use of isotretinoin, ciclosporin, tacrolimus, sirolimus, pimecrolimus or ocular cauterisation procedures 2 months before the screening visit and throughout the study
  • Use of VISMED® within 6 weeks prior to the screening visit
  • Refractive surgery (e.g. LASIK, LASEK, PRK) within 6 months and/or any other ocular laser/surgery within 3 months prior to the screening visit and during the study
  • Insertion of temporary punctal plug(s) within 2 months prior to the Screening visit or permanent occlusion of lacrimal puncta on one or both sides
  • Known hypersensitivity to any of the components of the study device or investigational products Non-ocular
  • History of severe systemic allergy
  • Systemic disease not stabilised within 1 month prior to the screening visit (e.g. diabetes with glycaemia out of range, thyroid dysfunction) or judged by the investigator to be incompatible with the conduct of the study procedures or the interpretation of the study results
  • Any change of systemic concomitant medication within the month before the screening visit or planned change during the study period, except paracetamol
  • Pregnancy or lactation at the screening and/or Baseline visit.
  • Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomised partner) from the Baseline visit throughout the conduct of the study treatment periods and up to 2 weeks after the study end. Post-menopausal women (two years without menstruation) do not need to use any method of birth control.
  • Participation in a clinical trial with an investigational substance within the past 30 days prior to Baseline visit.
  • Participation in another clinical study at the same time as the present study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Chru Brest Hopital Morvan

    Brest

  • Cabinet Liberal

    La Rochefoucauld

  • Hopitaux Universitaires Paris-Sud - Hopital Bicetre

    Le Kremlin-Bicêtre, Île-de-France Region, 94270

  • Hopital Edouard Herriot - Pavillon C

    Lyon

  • Institut Ophtalmologique Ouest Jules Verne

    Nantes

  • Hopital Necker - Ophtalmologie

    Paris

Other trials in France

About this study

Official title: 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

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

Read the 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
Being tested
Alocross 0.2% Unit Dose, Vismed
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alocross 0.2% Unit DoseDevice

    Eye Drops

  • VismedDevice

    Also called HA 0.18% hypotonic solution

    Eye drops

Study groups in NCT04685109
Study groupRoleWhat they receive
AlocrossExperimentalCross-linked HA 0.2% + Aloe Vera 0.1% solution (N=40) Posology: One Drop in each eye 4 times daily for 84 days
Receives: Device: Alocross 0.2% Unit Dose
VismedActive comparatorHA 0.18% hyaluronic solution (N40) Posology: One Drop in each eye 4 times daily for 84 days
Receives: Device: Vismed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of ocular surface staining (OSS) score between baseline and Day 28.

    The primary endpoint of the study is the difference between patients treated with ALOCROSS® and patients treated with VISMED® in the change of ocular surface staining (OSS) score between baseline and D28.

    An OSS higher than 0 is considered to be abnormal and may be a sign of KCS. But scores of 1 or 2 can also represent a late staining artifact if interpretation of the fluorescein corneal staining pattern is delayed beyond 8 minutes. Because this could lead to a high level of misclassification, an abnormal OSS is defined as being a score of 3 or above.

    Measured: Between Baseline and day 28

Secondary outcomes (7)

  1. Change of ocular surface staining (OSS) score between baseline and Day 84

    The difference between patients treated with ALOCROSS® and patients treated with VISMED® in change of OSS score between baseline and Day 84.

    An OSS higher than 0 is considered to be abnormal and may be a sign of KCS. But scores of 1 or 2 can also represent a late staining artifact if interpretation of the fluorescein corneal staining pattern is delayed beyond 8 minutes. Because this could lead to a high level of misclassification, an abnormal OSS is defined as being a score of 3 or above.

    Measured: between baseline and Day 14 and between baseline and Day 84

  2. The change of ocular stainings (corneal fluorescein staining (CFS) and clearing and conjunctival staining) between baseline and Day 28 and between baseline and Day 84

    The difference between patients treated with ALOCROSS® and patients treated with VISMED® in change of ocular stainings (corneal fluorescein staining (CFS) and clearing and conjunctival staining)

    Staining using fluorescein will be graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 per area [cornea + nasal and temporal conjunctiva]) for cornea and conjunctiva separately, On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 corresponds to one staining dot per area. A CFS grade of 0 represents complete corneal clearing.

    Measured: between baseline and Day 28 and between baseline and Day 84

  3. The change of ocular discomfort symptoms on Visual Analogue Scale

    The difference between patients treated with ALOCROSS® and patients treated with VISMED® in the change of ocular discomfort symptoms according to the Visual Analogue Scale (VAS)

    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.

    Measured: between baseline and Day 28 and between baseline and Day 84

  4. The change tear breakup time (TBUT)

    The difference between patients treated with ALOCROSS® and patients treated with VISMED® in the change of tear breakup time (TBUT)

    Generally, >10 seconds is thought to be normal,(10, 11, 12) 5 to 10 seconds, marginal, and < 5 seconds is considered low. A short tear break-up time is a sign of a poor tear film and the longer it takes the more stable the tear film.

    Measured: between baseline and Day 28 and between baseline and Day 84

  5. The change in Schirmer's tear test

    The difference between patients treated with ALOCROSS® and patients treated with VISMED® in the change of Schirmer's tear test

    Healthy eyes are considered to leave each strip of paper containing more than 10 millimeters of moisture. Less than 10 millimeters of moisture indicates probable dry eye syndrome.

    Measured: between baseline and Day 28 and between baseline and Day 84

  6. The secondary endpoints are the difference between patients treated with ALOCROSS® and patients treated with VISMED® in:

    The overall efficacy evaluation of the investigator

    The study investigator at each centre will conduct an overall assessment of the effect of the study device on improvement in the patients DED using the following rating scale:

    • 0 = Unsatisfactory
    • 1 = Not very satisfactory
    • 2 = Satisfactory
    • 3 = Very satisfactory

    Measured: after 12 weeks of treatment (84 days)

  7. The difference between patients treated with ALOCROSS® and patients treated with VISMED® in:

    The change of subjective assessments evaluation by the patient. The patient will rate his global evaluation of efficacy using the same rating scale as the Investigator.

    The patients complete a subjective assessment of the effect of the study device on improvement in their DED using the following rating scale:

    • 0 = Unsatisfactory
    • 1 = Not very satisfactory
    • 2 = Satisfactory
    • 3 = Very satisfactory

    Measured: between baseline and Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start11 May 2021
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
PROSPECTIVE, MULTICENTRE, INVESTIGATOR-MASKED, PARALLEL-GROUP, ACTIVE-CONTROLLED, RANDOMISED, NON-INFERIORITY STUDY
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685109
Sponsor's protocol ID
RE-015B
Acronym
ALHENA
Status last verified
May 2025
First submitted
4 Dec 2020
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Alocross 0.2% Unit Dose and Vismed in people with Dry Eye Syndromes, run by Santen SAS at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of ocular surface staining (OSS) score between baseline and Day 28. (time frame: Between Baseline and day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04685109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.

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