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

NCT03821415 | Completed Phase 2

• 1 other identifier: RP101-200
• Study Type: interventional
• Target: 104
• Locations: 3 countries
• Sites: 8

Brief Summary

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

Conditions

Dry Eye Syndromes

Keywords

Keratoconjunctivitis sicca; Dry Eye Disease; Slow-release; Ophthalmology; Topical Eye Disease

Outcome Measures

Primary Outcomes (1)

• Schirmer's test type II (with anaesthesia)

  Schirmer's test uses sterile strips inserted into the eye to measure the basal aqueous tear secretion.

  From Screening up to 90 days

Secondary Outcomes (9)

• Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, redness, tearing, eyelid swelling and photophobia)

  From Screening up to 90 days

• Symptom assessment in Dry Eye (SANDE)

  From Screening up to 90 days

• Visual acuity assessment using an Early Treatment Diabetic Retinopathy Study [ETDRS] chart

  From Screening up to 90 days

• Slit lamp examination (SLE)

  From Screening up to 90 days

• TFBUT

  From Screening up to 90 days

Study Arms (4)

1 - RP101 0.05%

EXPERIMENTAL

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

2 - RP101 0.1% / Placebo

EXPERIMENTAL

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

3 - RP101 0.1%

EXPERIMENTAL

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

4 - Placebo

PLACEBO COMPARATOR

RP101 matching placebo, ophthalmic sterile solution, one drop each eye every 12 h (b.i.d.) for 90 consecutive days

Drug: RP101

Interventions

RP101 DRUG

17β-oestradiol-3-phosphate ophthalmic sterile solution

Also known as: 17β-oestradiol-3-phosphate

1 - RP101 0.05%; 2 - RP101 0.1% / Placebo; 3 - RP101 0.1%; 4 - Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Redwood Pharma AB: lead
• Cross Research S.A.: collaborator

Study Sites (8)

Medical University of Vienna - Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Universitätsmedizin Greifswald, Klinik und Poliklinik für Augenheilkunde

Greifswald, 17475, Germany

Location

Universitätsmedizin Mainz Augenklinik und Poliklinik Klinisches

Mainz, 55131, Germany

Location

Klinikum rechts der Isar der Technischen Universität München, Anstalt des öffentlichen Rechts Klinik und Poliklinik für Augenheilkunde

München, 81675, Germany

Location

Óbudai Egészség Centrum

Budapest, 1036, Hungary

Location

Swan Med Hungary Kft.

Létavértes, 4281, Hungary

Location

MacroKlinika

Miskolc, 3526, Hungary

Location

Mentaház Magánorvosi Központ

Székesfehérvár, 8000, Hungary

Location

Related Publications (1)

• Schmidl D, Szalai L, Kiss OG, Schmetterer L, Garhofer G. A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial of a Topical Estradiol Ophthalmic Formulation in Postmenopausal Women with Moderate-to-Severe Dry Eye Disease. Adv Ther. 2021 Apr;38(4):1975-1986. doi: 10.1007/s12325-021-01680-3. Epub 2021 Mar 12.

  PMID: 33710587 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Study Officials

• Ulf Björklund, MSc Pharm

  Redwood Pharma AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentre, randomised, double-masked, parallel-group, placebo-controlled Phase II study

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 29, 2019
• Study Start: January 18, 2019
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

HU (4); AU (1); DE (3)