Status:
COMPLETED
Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis
Lead Sponsor:
RVL Pharmaceuticals, Inc.
Conditions:
Blepharoptosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an exploratory, proof of concept study to evaluate the safety and efficacy of RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in patients with ptosis.
Detailed Description
This is an exploratory, proof-of-concept study. The objectives include establishing the efficacy and duration of effect of once daily (QD) or twice daily (BID) administration of RVL-1201 and the safet...
Eligibility Criteria
Inclusion
- Adult male or female subjects 18 years of age and older.
- Presence of all of the following at Screening:
- Loss on HVF 36-point ptosis protocol test of ≥ 8 points in points not seen at or above 10° from fixation in the superior visual field; AND
- Marginal reflex distance (MRD), the distance from the central pupillary light reflex to the upper lid margin, of ≤ 2.5 mm in the same eye as Inclusion Criterion #2a; AND
- Corrected Snellen visual acuity (VA) of 20/40 or better (refraction must be within 6 months of Visit 1) in the same eye as Inclusion Criteria #2a and #2b.
- No contraindications for treatment of both eyes as specified in Exclusion Criteria #1-14.
- Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study.
- Provide informed consent prior to undergoing any study-related procedures.
Exclusion
- In either eye:
- Congenital ptosis
- Pseudoptosis
- Horner syndrome
- Marcus Gunn jaw-winking syndrome
- Myasthenia gravis
- Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos
- Dermatochalasis as the sole cause of the signs of ptosis
- Previous ptosis surgery
- Lid position affected by lid or conjunctival scarring
- Current use of prescribed dry eye medication or punctal plugs; artificial tears are allowed
- Visual field loss from any cause other than ptosis
- Inability to fixate on the central fixation target of the HVF
- Primary open-angle glaucoma or ocular hypertension, intraocular pressure (IOP) \> 24 mm Hg, or current use/use within 1 month prior to Visit 1 of any antiglaucoma medications.
- History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed \> 3 months prior to Visit 1 and IOP \< 20 mm Hg) or normal-tension glaucoma
- Use of over-the-counter vasoconstrictor/decongestant eye medication (eg, Visine® L.R.®) or any α-adrenergic agonist (including OTC products) at any time during the study
- Contact lens wear during the study period
- General:
- Resting heart rate (HR) outside the normal range (60 - 100 beats per minute)
- Hypertension diastolic blood pressure (BP) \> 105 mm Hg
- Use of monoamine oxidase inhibitors (MAOIs; eg, isocarboxazid, phenelzine, tranylcypromine) within 14 days prior to Visit 1 or during the study
- Use of beta blockers (eg, propranolol, metoprolol, labetalol) within 14 days prior to Visit 1 or during the study
- Use of maprotiline, selective serotonin reuptake inhibitors (\[SSRIs\] eg, citalopram, escitalopram, paroxetine, fluoxetine, fluvoxamine, sertraline) or tricyclic antidepressants (eg, amitriptyline, doxepin, nortriptyline, amoxapine, clomipramine, desipramine, imipramine, protriptyline, trimipramine) at any time during the study
- A history of myocardial infarction, angina, arrhythmia, or irregular pulse
- Advanced arteriosclerotic disease
- History of thyroid disease
- Insulin-dependent diabetes or diabetes requiring oral hypoglycemic drugs; diet-controlled diabetes is allowed
- Pregnancy or lactation
- Diagnosed benign prostatic hypertrophy requiring medicinal therapy.
- History of contact or systemic allergic reaction to oxymetazoline or other sympathomimetic drugs (eg, phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, fepradinol, or methoxamine)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01848041
Start Date
May 1 2013
End Date
February 1 2014
Last Update
November 26 2021
Active Locations (1)
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1
Morrow, Georgia, United States, 30260