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Effects of RP101 in Post-menopausal Women With Dry Eye Syndrome

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821415
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Cross Research S.A.
Information provided by (Responsible Party):
Redwood Pharma AB

Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE January 18, 2019
Actual Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
Schirmer's test type II (with anaesthesia) [ Time Frame: From Screening up to 90 days ]
Schirmer's test uses sterile strips inserted into the eye to measure the basal aqueous tear secretion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, redness, tearing, eyelid swelling and photophobia) [ Time Frame: From Screening up to 90 days ]
    It will be assigned by the patients using a 100 mm VAS.
  • Symptom assessment in Dry Eye (SANDE) [ Time Frame: From Screening up to 90 days ]
    The patient symptoms of ocular dryness and/or irritation will be quantified on a Visual Analogue Scale (VAS) 0-100 mm based on two questions that inquire about both severity and frequency of symptoms. The patients will evaluate their symptoms on the VAS scale giving the value they are feeling from none (0 mm) to an extreme value (100 mm).
  • Visual acuity assessment using an Early Treatment Diabetic Retinopathy Study [ETDRS] chart [ Time Frame: From Screening up to 90 days ]
    Best correction will be determined by careful refraction using a retroilluminated ETDRS 4 meter distance acuity chart. The correct number of letters read by the patient is recorded and evaluated.
  • Slit lamp examination (SLE) [ Time Frame: From Screening up to 90 days ]
    The SLE will be performed before the instillation of any dilating or anaesthetic eye drops or the fluorescein agent.
  • TFBUT [ Time Frame: From Screening up to 90 days ]
    Tear film break up time (TFBUT) will be measured by determining the time to tear break-up after instillation of sodium fluorescein solution into the inferior conjunctival culde-sac of each eye.
  • Fundus ophthalmoscopy [ Time Frame: From Screening up to 90 days ]
    The fundus examination will include ophthalmoscopic assessments of vitreous, macula, retina and optic nerve head for both eyes.
  • Corneal fluorescein staining [ Time Frame: From Screening up to 90 days ]
    The corneal fluorescein staining evaluates cornea and conjunctiva epithelium damage.
  • Treatment-emergent Adverse Event (TEAEs) [ Time Frame: From Screening up to 104 days ]
    All adverse events (AEs) derived by spontaneous, unsolicited reports of the subjects, by observation and by routine open questioning will be collected and reported.
  • 17-β-oestradiol serum concentrations [ Time Frame: Day 1 and Day 90 ]
    Using a fully validated analytical method.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of RP101 in Post-menopausal Women With Dry Eye Syndrome
Official Title  ICMJE A Phase II, Multicentre, Randomised, Placebo-controlled, Doublemasked Trial of RP101 Ophthalmic Formulation Versus Vehicle in Post-menopausal Women With Moderate to Severe Dry Eye Syndrome
Brief Summary The main purpose of this study is to establish whether RP101 can reduce symptoms of dry eye syndrome in post-menopausal women.
Detailed Description

Redwood Pharma is developing the novel ophthalmic product RP101 containing the known active substance 17β-oestradiol-3-phosphate and based upon the drug delivery platform IntelliGel which controls the active substance release. The novel formulation is planned to meet the still unmet medical need of an efficacious treatment against chronic dry eye in postmenopausal women.

The efficacy of the novel formulation RP101 will be investigated for the first time in the present multicentre, randomised, double-masked, parallel-group, placebo-controlled Phase II study in women post-menopausal for at least 3 years presenting with symptoms specific for dry eye syndrome of moderate to severe intensity.

The planned study will be conducted in Austria, Germany and Hungary. The primary objective of the study is to establish the effective dose/dose regimen of RP101 in these patients applying RP101 ophthalmic sterile solution or matching placebo (vehicle) once (q.d.) or twice a day (b.i.d.) for 3 months. One hundred (100) patients will be enrolled in this study. The subjects will be randomly assigned (1:1:1:1) to a treatment group and will receive one of the treatments for 90 consecutive days.

Evaluation of the clinical efficacy during and at the end of the treatment will be done on the basis of the Schirmer's test type II (with anaesthesia).

The secondary objectives of the study are:

  • to evaluate the safety and tolerability of the treatment
  • to evaluate the pharmacokinetics (PK) of serum 17β-oestradiol after the 1st and the last dose (only PK substudy).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicentre, randomised, double-masked, parallel-group, placebo-controlled Phase II study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE Drug: RP101
17β-oestradiol-3-phosphate ophthalmic sterile solution
Other Name: 17β-oestradiol-3-phosphate
Study Arms  ICMJE
  • Experimental: 1 - RP101 0.05%
    RP101 0.05% (w/w) 17β-oestradiol-3-phosphate ophthalmic sterile solution, one drop each eye every 12 h (b.i.d.) for 90 consecutive days
    Intervention: Drug: RP101
  • Experimental: 2 - RP101 0.1% / Placebo
    RP101 0.1% (w/w) 17β-oestradiol-3-phosphate ophthalmic sterile solution, one drop each eye in the morning (q.d.) followed by one drop of placebo each eye in the evening for 90 consecutive days
    Intervention: Drug: RP101
  • Experimental: 3 - RP101 0.1%
    RP101 0.1% (w/w) 17β-oestradiol-3-phosphate ophthalmic sterile solution, one drop each eye every 12 h (b.i.d.) for 90 consecutive days
    Intervention: Drug: RP101
  • Placebo Comparator: 4 - Placebo
    RP101 matching placebo, ophthalmic sterile solution, one drop each eye every 12 h (b.i.d.) for 90 consecutive days
    Intervention: Drug: RP101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2019)
104
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
100
Actual Study Completion Date  ICMJE November 18, 2019
Actual Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent: signed written informed consent before inclusion in the study
  • Sex and menopause: postmenopausal women; postmenopausal condition defined as final menstrual period at least 3 years before the screening
  • Dry eye syndrome: patients with moderate to severe dry eye syndrome
  • Tear film breakup time: TFBUT ≤ 10 sec in the worse eye (study eye)
  • Visual acuity: corrected visual acuity ≥ 20/200 in each eye
  • 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
  • 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

Exclusion Criteria:

  • Meibomian gland dysfunction: severe Meibomian gland dysfunction defined as lid deformity, marked lid margin hyperaemia or severe Meibomian gland loss
  • Ophthalmic treatment: current use of topical ophthalmic medications other than ocular lubricants or artificial tears within 30 days before the screening
  • 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
  • Ophthalmic diseases: severe forms of ophthalmic surface diseases e.g. ocular pemphigoid, Sjögren's disease, exposure keratitis
  • 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
  • Diseases: uncontrolled systemic diseases including cardiovascular, pulmonary and/or renal diseases, diabetes, hypertension; history of ovarian, breast or uterine cancer or unexplained vaginal bleeding
  • Investigative drug studies: participation in the evaluation of any investigational product or medical device for 30 days before this study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821415
Other Study ID Numbers  ICMJE RP101-200
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Redwood Pharma AB
Study Sponsor  ICMJE Redwood Pharma AB
Collaborators  ICMJE Cross Research S.A.
Investigators  ICMJE
Study Director: Ulf Björklund, MSc Pharm Redwood Pharma AB
PRS Account Redwood Pharma AB
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP