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

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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

Brief Summary:
The main purpose of this study is to establish whether RP101 can reduce symptoms of dry eye syndrome in post-menopausal women.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: RP101 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
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
Official Title: 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
Actual Study Start Date : January 18, 2019
Actual Primary Completion Date : November 18, 2019
Actual Study Completion Date : November 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
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
Drug: RP101
17β-oestradiol-3-phosphate ophthalmic sterile solution
Other Name: 17β-oestradiol-3-phosphate

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
Drug: RP101
17β-oestradiol-3-phosphate ophthalmic sterile solution
Other Name: 17β-oestradiol-3-phosphate

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
Drug: RP101
17β-oestradiol-3-phosphate ophthalmic sterile solution
Other Name: 17β-oestradiol-3-phosphate

Placebo Comparator: 4 - Placebo
RP101 matching placebo, ophthalmic sterile solution, one drop each eye every 12 h (b.i.d.) for 90 consecutive days
Drug: RP101
17β-oestradiol-3-phosphate ophthalmic sterile solution
Other Name: 17β-oestradiol-3-phosphate




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Corneal fluorescein staining [ Time Frame: From Screening up to 90 days ]
    The corneal fluorescein staining evaluates cornea and conjunctiva epithelium damage.

  8. 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.

  9. 17-β-oestradiol serum concentrations [ Time Frame: Day 1 and Day 90 ]
    Using a fully validated analytical method.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821415


Locations
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Austria
Medical University of Vienna - Department of Clinical Pharmacology
Vienna, Austria, 1090
Germany
Universitätsmedizin Greifswald, Klinik und Poliklinik für Augenheilkunde
Greifswald, Germany, 17475
Universitätsmedizin Mainz Augenklinik und Poliklinik Klinisches
Mainz, Germany, 55131
Klinikum rechts der Isar der Technischen Universität München, Anstalt des öffentlichen Rechts Klinik und Poliklinik für Augenheilkunde
München, Germany, 81675
Hungary
Óbudai Egészség Centrum
Budapest, Hungary, 1036
Swan Med Hungary Kft.
Létavértes, Hungary, 4281
MacroKlinika
Miskolc, Hungary, 3526
Mentaház Magánorvosi Központ
Székesfehérvár, Hungary, 8000
Sponsors and Collaborators
Redwood Pharma AB
Cross Research S.A.
Investigators
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Study Director: Ulf Björklund, MSc Pharm Redwood Pharma AB
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Responsible Party: Redwood Pharma AB
ClinicalTrials.gov Identifier: NCT03821415    
Other Study ID Numbers: RP101-200
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Redwood Pharma AB:
Keratoconjunctivitis sicca
Dry Eye Disease
Slow-release
Ophthalmology
Topical Eye Disease
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs