moderate or severe dry eye syndrome MedDRA version: 20.0 Level: PT Classification code 10013774 Term: Dry eye System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Code: RP101 0.05%
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: to be considered
CAS Number: N/A
Current Sponsor
Sponsors
Redwood Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent: signed written informed consent before inclusion in the study 2.Sex and menopause: postmenopausal women; postmenopausal condition defined as final menstrual period at least 3 years before the screening 3.Dry eye syndrome: patients with moderate to severe dry eye syndrome 4.Schirmer’s test type II: Schirmer’s test with anaesthesia = 7 mm/5 min in the worse eye (study eye) 5.Fluorescein: corneal fluorescein staining score = 2.0 in one or more regions of the worse eye (study eye) and = 10 in total across all 5 corneal regions according to the NEI scale 6.Tear film breakup time: TFBUT = 10 sec in the worse eye (study eye) 7.Visual acuity: corrected visual acuity = 20/200 in each eye 8.Symptoms: at least 2 of the typical dry eye syndrome symptoms since at least 3 months before the screening: foreign body sensation, burning/stinging, redness, tearing, pain, itching, blurred vision, photophobia, eyelid swelling, moisture and mucous discharge 9.Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1.Hysterectomy: women younger than 55 with partial or complete hysterectomy 2.Meibomian gland dysfunction: severe Meibomian gland dysfunction defined as lid deformity, marked lid margin hyperaemia or severe Meibomian gland loss 3.Ophthalmic treatment: current use of topical ophthalmic medications other than ocular lubricants or artificial tears within 30 days before the screening 4.Ocular infection and inflammation: presence of any bacterial or viral or fungal infection in either eye or active inflammation not related to dry eye disease (i.e. follicular conjunctivitis, iris or preauricular adenopathy) in either eye 5.Ophthalmic diseases: severe forms of ophthalmic surface diseases e.g. ocular pemphigoid, Sjögren’s disease, exposure keratitis 6.Ophthalmic surgery: history of ophthalmic surgery or trauma in the last 6 months; history of laser-assisted in situ keratomileusis (LASIK) in the previous 12 months 7.Intraocular pressure: intraocular pressure >21 mmHg 8.Contact lenses: use of therapeutic or refractive contact lenses in either eye within 30 days of study enrolment 9.Concomitant treatments: topical cyclosporine; topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days before the screening; systemic medications admitted only if at a stable dose for at least 3 months before the screening; systemic or topical hormonal therapies within 3 months before the screening 10.Allergy: ascertained or presumptive hypersensitivity to the active principle and/or ingredients of investigational product or Oculotect® or rescue medication; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study 11.Diseases: uncontrolled systemic diseases including cardiovascular (in particular, history of or active deep vein thrombosis or active or recent thromboembolism disease), pulmonary (in particular history of or active pulmonary embolism), hepatic and/or renal diseases or dysfunctions, diabetes, hypertension; known, suspected or history of ovarian, breast or uterine cancer or known or suspected oestrogen-dependent neoplasia or unexplained vaginal or genital bleeding; risk of endometrial hyperplasia 12.Investigative drug studies: participation in the evaluation of any investigational product or medical device for 30 days before this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to establish the effective dose/dose regimen of RP101 in post-menopausal women with moderate to severe dry eye syndrome applying RP101 ophthalmic sterile solution or matching placebo (vehicle) once (q.d.) or twice a day (b.i.d.) for 3 months; Secondary Objective: The secondary objectives of the study are: - to evaluate the safety and tolerability of the treatment - to evaluate as exploratory variables tear film osmolarity and corneal pachymetry in specific substudies - to evaluate the pharmacokinetics (PK) of serum 17-ß-oestradiol after the 1st and the last dose (only PK substudy) ;Primary end point(s): The primary end point is the evaluation of the clinical efficacy during and at the end of the treatment with RP101 ophthalmic sterile solution or matching placebo (vehicle);Timepoint(s) of evaluation of this end point: Schirmer test type II (with anaesthesia) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are: - Evaluation of the clinical efficacy during and at the end of treatment with RP101 ophthalmic sterile solution or matching placebo (vehicle) - Evaluation of the clinical safety during and at the end of treatment with RP101 ophthalmic sterile solution or matching placebo (vehicle) - evaluation of the PK of serum 17-ß-oestradiol after the 1st and the last dose of treatment with RP101 ophthalmic sterile solution (only in the pk stubstudy) ; Timepoint(s) of evaluation of this end point: - VAS for ocular tolerability - Symptom Assessment in Dry Eye (SANDE) - Visual acuity (ETDRS chart) - Slit lamp examination (SLE) - Tear film osmolarity - Tear film break up time (TFBUT) - Fundus ophthalmoscopy - Corneal fluorescein staining - Corneal pachymetry - Frequency of instillation (i.e. number of drops instilled daily) of artificial tears (rescue medication) during the treatment phase - Intraocular pressure (IOP) - Treatment-emergent adverse events (TEAEs) - Clinical laboratory assays including haematology, blood chemistry and endocrinology - Vital signs (blood pressure; BP, pulse rate; PR), body weight (BW), physical examinations - 17-ß-oestradiol serum concentrations, Cmax, Tmax and AUC0-t | — |
Countries
Austria, Germany, Hungary
Contacts
Public ContactClinical Project Unit
CROSS Research S.A.
Outcome results
None listed