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

NCT ID: NCT04685109

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2026-09-30

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

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Alocross 0.2% Unit Dose

Intervention Type: DEVICE

Eye Drops

Vismed

HA 0.18% hyaluronic solution (N40) Posology: One Drop in each eye 4 times daily for 84 days

Group Type: ACTIVE_COMPARATOR

Vismed

Intervention Type: DEVICE

Eye drops

Interventions

Alocross 0.2% Unit Dose

Eye Drops

Intervention Type: DEVICE

Vismed

Eye drops

Intervention Type: DEVICE

Other Intervention Names

HA 0.18% hypotonic solution

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santen SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

France

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

RE-015B

Identifier Type: -

Identifier Source: org_study_id