Phase
Condition
Presbyopia
Treatment
Placebo
0.75% phentolamine ophthalmic solution
Clinical Study ID
Ages 45-64 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must meet all of the following criteria:
Males or females ≥ 45 and ≤ 64 years of age
Able to comply with all protocol-mandated procedures independently and to attend allscheduled office visits
Able and willing to give signed informed consent
Able to self-administer study medication throughout the study period Inclusion criteria #5, #6, and #7 must all be met at both Screening and BaselineVisits:
BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20Snellen equivalent) or better in photopic conditions in each eye
DCNVA of 50 ETDRS letters (20/50 Snellen equivalent) or worse but not <35 ETDRSletters (20/100 Snellen equivalent) in photopic conditions in each eye andbinocularly
For participants who depend on reading glasses or bifocals, binocular best-correctednear VA of 65 ETDRS letters (20/25 Snellen equivalent) or better
Photopic PD of ≥ 4 mm in the study eye at Screening
Exclusion
Exclusion Criteria:
Excluded from the study will be individuals with any of the following characteristics:
Ophthalmic (in either eye):
Use of any topical prescription (including Vuity® or Qlosi™) or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until studycompletion, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lidscrub, SteriLid®, baby shampoo, etc.) and artificial tears as specified in ExclusionCriterion #2 below
Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15min before or after instillation of study medication
Use of Ryzumvi™ (POS) within 7 days prior to Screening
Use of any dry eye product, such as topical ophthalmic therapy for dry eye (eg,generic cyclosporine, Restasis®, Xiidra®, Cequa®, Eysuvis®, and Meibo®) orintranasal dry eye product (eg, Tyrvaya®) or other devices within 12 months prior toScreening
Tear break-up time of < 5 seconds or corneal fluorescein staining (CFS) Grade ≥ 2 inthe inferior zone or Grade ≥ 1 in the central zone using the National Eye Institutescale
Clinically significant ocular disease (eg, cataract, glaucoma, corneal edema,uveitis, retinal degeneration, loss of visual field, or any macular pathology) that,in the judgment of the Investigator, might interfere with study procedures
Recent or current evidence of ocular infection or inflammation in either eye (suchas current evidence of clinically significant blepharitis, conjunctivitis,keratitis, etc.). Participants must be symptom free for at least 7 days prior toScreening
Any history of herpes simplex or herpes zoster keratitis
Known allergy, hypersensitivity, or contraindication to any component of thephentolamine or vehicle formulations
Prior participation in a study involving the use of POS for the treatment ofpresbyopia or night vision disturbance
History of cauterization of the punctum or punctal plug (silicone or collagen)insertion or removal
Ocular trauma within 6 months prior to Screening
Ocular surgery or any ocular laser treatment within 6 months prior to Screening. Anyhistory of radial keratotomy is prohibited
Participants with surgical monovision, multifocal, or extended depth-of-focusintraocular lenses (IOLs). Monofocal IOLs are acceptable if in place > 6 monthsprior to Screening
Monofocal IOL in place > 6 months prior to Screening with any posterior capsuleopacification
History of any traumatic (surgical or nonsurgical) or nontraumatic conditionaffecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupildisorder, iris atrophy, iridotomy, iridectomy, iritis, etc.)
Unwilling or unable to discontinue use of contact lenses at least 1 hour prior toScreening for soft contact lenses or at least 8 hours prior to Screening for hardgas permeable contact lenses, and at least 8 hours (for both types of lenses) priorto all other office visits Systemic:
Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptorantagonists (eg, chronic obstructive pulmonary disease or bronchial asthma;abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heartblockage or congestive heart failure)
Known hypersensitivity or contraindication to any systemic cholinergicparasympathomimetic agent
Clinically significant systemic disease (eg, uncontrolled diabetes, myastheniagravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that mightinterfere with the study as deemed by the judgment of the Investigator
Initiation of treatment with, or any changes to, the current dosage, drug, orregimen of any systemic adrenergic or cholinergic drugs within 7 days prior toScreening or during the study; however, Flomax® (tamsulosin) is specificallyexcluded
Participation in any investigational study within 30 days prior to Screening
Females of childbearing potential who are pregnant, nursing, planning a pregnancy,or not using a medically acceptable form of birth control. Acceptable methodsinclude the use of at least one of the following: intrauterine device, hormonalcontraception (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. A female is considered to be of childbearingpotential unless she is 1 year postmenopausal or 3 months post-surgicalsterilization. All females of childbearing potential, including those withpost-tubal ligation, must have a negative urine pregnancy test result at Visit 1 (Screening)
Resting HR outside the range of 50 to 110 beats per min (bpm) following at least a 5min rest period in the sitting position at Visit 1 (Screening). HR may be repeatedonly once if outside the specified range, following another 5 min rest period in thesitting position
Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHgfollowing at least a 5-min rest period in the sitting position at Visit 1 (Screening). BP may be repeated only once if outside the specified range, followinganother 5-min rest period in the sitting position
Study Design
Study Description
Connect with a study center
United States
Phoenix, Arizona 85028
United StatesSite Not Available
United States
Scottsdale, Arizona 85260
United StatesSite Not Available
United States
Glendale, California 91204
United StatesSite Not Available
United States
Newport Beach, California 92663
United StatesSite Not Available
United States
Delray Beach, Florida 33484
United StatesSite Not Available
United States
Longwood, Florida 32779
United StatesSite Not Available
United States
Indianapolis, Indiana 46260
United StatesSite Not Available
United States
Rochester, New York 14618
United StatesSite Not Available
United States
Garner, North Carolina 27529
United StatesSite Not Available
United States
Athens, Ohio 45701
United StatesSite Not Available
United States
Warwick, Rhode Island 02888
United StatesSite Not Available
United States
Goodlettsville, Tennessee 37072
United StatesSite Not Available
United States
Memphis, Tennessee 38119
United StatesSite Not Available
United States
San Antonio, Texas 78229
United StatesSite Not Available
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