A Phase 2 interventional study of RP101 in Dry Eye Syndromes, sponsored by Redwood Pharma AB. Completed at 8 sites in 3 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2019-12-20.
Sponsored by Redwood Pharma AB · Phase 2, Interventional, and Treatment
The main purpose of this study is to establish whether RP101 can reduce symptoms of dry eye syndrome in post-menopausal women.
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:
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 104 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Redwood Pharma AB as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
Also known as: 17β-oestradiol-3-phosphate
Schirmer's test type II (with anaesthesia)
Schirmer's test uses sterile strips inserted into the eye to measure the basal aqueous tear secretion.
Time frame: From Screening up to 90 days
Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, redness, tearing, eyelid swelling and photophobia)
It will be assigned by the patients using a 100 mm VAS.
Time frame: From Screening up to 90 days
Symptom assessment in Dry Eye (SANDE)
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).
Time frame: From Screening up to 90 days
Visual acuity assessment using an Early Treatment Diabetic Retinopathy Study [ETDRS] chart
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.
Time frame: From Screening up to 90 days
Slit lamp examination (SLE)
The SLE will be performed before the instillation of any dilating or anaesthetic eye drops or the fluorescein agent.
Time frame: From Screening up to 90 days
TFBUT
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.
Time frame: From Screening up to 90 days
Fundus ophthalmoscopy
The fundus examination will include ophthalmoscopic assessments of vitreous, macula, retina and optic nerve head for both eyes.
Time frame: From Screening up to 90 days
Corneal fluorescein staining
The corneal fluorescein staining evaluates cornea and conjunctiva epithelium damage.
Time frame: From Screening up to 90 days
Treatment-emergent Adverse Event (TEAEs)
All adverse events (AEs) derived by spontaneous, unsolicited reports of the subjects, by observation and by routine open questioning will be collected and reported.
Time frame: From Screening up to 104 days
17-β-oestradiol serum concentrations
Using a fully validated analytical method.
Time frame: Day 1 and Day 90
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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