A study of the ophtalmic formulation RP101 versus placebo in post-menopausal women with moderate to severe dry eye syndrome

Phase 1

• Conditions: Moderate to severe dry eye syndrome; MedDRA version: 20.0Level: PTClassification code 10013774Term: Dry eyeSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-005160-18-DE
• Lead Sponsor: Redwood Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-11
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

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

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, pulmonary and/or renal diseases, diabetes, hypertension; history of ovarian, breast or uterine cancer or unexplained vaginal bleeding
12. Investigative drug studies: participation in the evaluation of any investigational product or medical device for 30 days before this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified