Clinical trial NCT04685109: 3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Santen SAS
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PROSPECTIVE, MULTICENTRE, INVESTIGATOR-MASKED, PARALLEL-GROUP, ACTIVE-CONTROLLED, RANDOMISED, NON-INFERIORITY STUDY
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Change of ocular surface staining (OSS) score between baseline and Day 28.
timeFrame: Between Baseline and day 28
Secondary outcomes:
measure: Change of ocular surface staining (OSS) score between baseline and Day 84
timeFrame: between baseline and Day 14 and between baseline and Day 84
measure: 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
timeFrame: between baseline and Day 28 and between baseline and Day 84
measure: The change of ocular discomfort symptoms on Visual Analogue Scale
timeFrame: between baseline and Day 28 and between baseline and Day 84
measure: The change tear breakup time (TBUT)
timeFrame: between baseline and Day 28 and between baseline and Day 84
measure: The change in Schirmer's tear test
timeFrame: between baseline and Day 28 and between baseline and Day 84
measure: The secondary endpoints are the difference between patients treated with ALOCROSS® and patients treated with VISMED® in:
timeFrame: after 12 weeks of treatment (84 days)
measure: The difference between patients treated with ALOCROSS® and patients treated with VISMED® in:
timeFrame: between baseline and Day 84
Other outcomes:
Locations:
city: Brest
country: France
facility: Chru Brest Hopital Morvan
city: La Rochefoucauld
country: France
facility: Cabinet Liberal
city: Lyon
country: France
facility: Hopital Edouard Herriot - Pavillon C
city: Nantes
country: France
facility: Institut Ophtalmologique Ouest Jules Verne
city: Paris
country: France
facility: Hopital Necker - Ophtalmologie
city: Le Kremlin-Bicêtre
country: France
facility: Hopitaux Universitaires Paris-Sud - Hopital Bicetre
state: Île-de-France
Study officials:
References: