Status:
ACTIVE_NOT_RECRUITING
3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
Lead Sponsor:
Santen SAS
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
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 ker...
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 2...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04685109
Start Date
May 11 2021
End Date
September 30 2026
Last Update
May 21 2025
Active Locations (6)
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1
Chru Brest Hopital Morvan
Brest, France
2
Cabinet Liberal
La Rochefoucauld, France
3
Hopital Edouard Herriot - Pavillon C
Lyon, France
4
Institut Ophtalmologique Ouest Jules Verne
Nantes, France