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

• Status: Completed
• Trial end date: 2019-11-18
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Redwood Pharma AB
• Collaborator: Cross Research S.A.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

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