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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04685109
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Santen SAS

Brief 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


Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Alocross 0.2% Unit Dose Device: Vismed Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PROSPECTIVE, MULTICENTRE, INVESTIGATOR-MASKED, PARALLEL-GROUP, ACTIVE-CONTROLLED, RANDOMISED, NON-INFERIORITY STUDY
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigator Masked, unmasked Pharmacist
Primary Purpose: Treatment
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
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Alocross
Cross-linked HA 0.2% + Aloe Vera 0.1% solution (N=40) Posology: One Drop in each eye 4 times daily for 84 days
Device: Alocross 0.2% Unit Dose
Eye Drops

Active Comparator: Vismed
HA 0.18% hyaluronic solution (N40) Posology: One Drop in each eye 4 times daily for 84 days
Device: Vismed
Eye drops
Other Name: HA 0.18% hypotonic solution




Primary Outcome Measures :
  1. Change of ocular surface staining (OSS) score between baseline and Day 28. [ Time Frame: 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.



Secondary Outcome Measures :
  1. Change of ocular surface staining (OSS) score between baseline and Day 84 [ Time Frame: between baseline and Day 14 and 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.


  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 [ Time Frame: 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.


  3. The change of ocular discomfort symptoms on Visual Analogue Scale [ Time Frame: between baseline and Day 28 and between baseline and Day 84 ]

    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.


  4. The change tear breakup time (TBUT) [ Time Frame: between baseline and Day 28 and between baseline and Day 84 ]

    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.


  5. The change in Schirmer's tear test [ Time Frame: between baseline and Day 28 and between baseline and Day 84 ]

    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.


  6. The secondary endpoints are the difference between patients treated with ALOCROSS® and patients treated with VISMED® in: [ Time Frame: after 12 weeks of treatment (84 days) ]

    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

  7. The difference between patients treated with ALOCROSS® and patients treated with VISMED® in: [ Time Frame: between baseline and Day 84 ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
    5. 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.
    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
  9. 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)
  10. Onset of lid hygiene (whatever the method) less than 2 months before the Screening visit
  11. Use of topical corticosteroids one month before the Screening Visit
  12. Use of isotretinoin, ciclosporin, tacrolimus, sirolimus, pimecrolimus or ocular cauterisation procedures 2 months before the screening visit and throughout the study
  13. Use of VISMED® within 6 weeks prior to the screening visit
  14. 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
  15. 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
  16. Known hypersensitivity to any of the components of the study device or investigational products Non-ocular
  17. History of severe systemic allergy
  18. 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
  19. Any change of systemic concomitant medication within the month before the screening visit or planned change during the study period, except paracetamol
  20. Pregnancy or lactation at the screening and/or Baseline visit.
  21. 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.
  22. Participation in a clinical trial with an investigational substance within the past 30 days prior to Baseline visit.
  23. Participation in another clinical study at the same time as the present study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685109


Contacts
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Contact: Julia L Martin, BSc +447483081798 julia.martin@santen.com

Locations
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France
Cabinet D'Ophtalmologie Foch Recruiting
Bordeaux, France
Contact: Bruno Mortemousque         
Chru Brest Hopital Morvan Recruiting
Brest, France
Contact: Beatrice Cochener Lamard         
Cabinet Liberal Recruiting
La Rochefoucauld, France
Contact: Olivier Auzerie         
Hopital Edouard Herriot - Pavillon C Completed
Lyon, France
Hopital Pasteur 2 Recruiting
Nice, France
Contact: Stephanie Baillif         
Fondation Rothschild Not yet recruiting
Paris, France
Contact: Eric Gabison         
Hopital Necker - Ophtalmologie Recruiting
Paris, France
Contact: Dominique Bremond-Gignac         
Chu Toulouse - Hopital Purpan Withdrawn
Toulouse, France
Chru Bretonneau Tours Withdrawn
Tours, France
Hopitaux Universitaires Paris-Sud - Hopital Bicetre Recruiting
Le Kremlin-Bicêtre, Île-de-France, France, 94270
Contact: Marc Labetoulle         
Sponsors and Collaborators
Santen SAS
  Study Documents (Full-Text)

Documents provided by Santen SAS:
Study Protocol  [PDF] July 6, 2020

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Responsible Party: Santen SAS
ClinicalTrials.gov Identifier: NCT04685109    
Other Study ID Numbers: RE-015B
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Conjunctivitis
Conjunctival Diseases
Corneal Diseases