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
Arizona Eye Center
Chandler, Arizona 85224
United StatesSite Not Available
Carrot Eye Center
Mesa, Arizona 85202
United StatesSite Not Available
Eye Doctors of Arizona
Phoenix, Arizona 85028
United StatesSite Not Available
United States
Phoenix, Arizona 85028
United StatesSite Not Available
MRB Eye Care Consultants, LLC
Scottsdale, Arizona 85260
United StatesSite Not Available
United States
Scottsdale, Arizona 85260
United StatesSite Not Available
United States
Phoenix 5308655, Arizona 5551752 85028
United StatesSite Not Available
United States
Scottsdale 5313457, Arizona 5551752 85260
United StatesSite Not Available
Empire Eye & Laser Center
Bakersfield, California 93309
United StatesSite Not Available
Global Research Management, Inc.
Glendale, California 91204
United StatesSite Not Available
United States
Glendale, California 91204
United StatesSite Not Available
Gordon Schanzlin New Vision Institute
La Jolla, California 92307
United StatesSite Not Available
LoBue Laser and Eye Medical Center, Inc.
Murrieta, California 92562
United StatesSite Not Available
Eye Research Foundation
Newport Beach, California 92663
United StatesSite Not Available
United States
Newport Beach, California 92663
United StatesSite Not Available
Wolstan and Goldberg Eye Associates
Torrance, California 90505
United StatesSite Not Available
United States
Glendale 5352423, California 5332921 91204
United StatesSite Not Available
United States
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
Segal Drug Trials, Inc.
Delray Beach, Florida 33484
United StatesSite Not Available
South Florida Glaucoma
Delray Beach, Florida 33484
United StatesSite Not Available
United States
Delray Beach, Florida 33484
United StatesSite Not Available
Bowden Eye & Associates
Jacksonville, Florida 32256
United StatesSite Not Available
Levenson Eye
Jacksonville, Florida 32204
United StatesSite Not Available
Shettle Eye Research
Largo, Florida 33773
United StatesSite Not Available
Sabal Eye Care/dba Omega Vision Center
Longwood, Florida 32779
United StatesSite Not Available
United States
Longwood, Florida 32779
United StatesSite Not Available
Mid Florida Eye Center
Mt. Dora, Florida 32757
United StatesSite Not Available
United States
Delray Beach 4153132, Florida 4155751 33484
United StatesSite Not Available
United States
Longwood 4162783, Florida 4155751 32779
United StatesSite Not Available
Virdi Eye Clinic
Rock Island, Illinois 61201
United StatesSite Not Available
Price Vision Group
Indianapolis, Indiana 46260
United StatesSite Not Available
United States
Indianapolis, Indiana 46260
United StatesSite Not Available
Durrie Vision
Overland Park, Kansas 66210
United StatesSite Not Available
Kannarr Eye Care
Pittsburg, Kansas 66762
United StatesSite Not Available
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas 66204
United StatesSite Not Available
The Eye Care Institute
Louisville, Kentucky 40206
United StatesSite Not Available
Fraser Eye Care Center
Fraser, Michigan 48026
United StatesSite Not Available
Moyes Eye Center
Kansas City, Missouri 64154
United StatesSite Not Available
Rochester Ophthalmological Group
Rochester, New York 14618
United StatesSite Not Available
United States
Rochester, New York 14618
United StatesSite Not Available
United States
Rochester 5134086, New York 5128638 14618
United StatesSite Not Available
Oculus Research , Inc.
Garner, North Carolina 27529
United StatesSite Not Available
United States
Garner, North Carolina 27529
United StatesSite Not Available
United States
Garner 4467657, North Carolina 4482348 27529
United StatesSite Not Available
Bergstrom Eye
Fargo, North Dakota 58103
United StatesSite Not Available
Red River Research Partners
Fargo, North Dakota 58103
United StatesSite Not Available
Athens Eye Care
Athens, Ohio 45701
United StatesSite Not Available
United States
Athens, Ohio 45701
United StatesSite Not Available
United States
Athens 4505542, Ohio 5165418 45701
United StatesSite Not Available
United States
Warwick, Rhode Island 02888
United StatesSite Not Available
West Bay Eye Associates
Warwick, Rhode Island 02888
United StatesSite Not Available
United States
Warwick 5225507, Rhode Island 5224323 02888
United StatesSite Not Available
Advancing Vision Research
Goodlettsville, Tennessee 37072
United StatesSite Not Available
United States
Goodlettsville, Tennessee 37072
United StatesSite Not Available
Optometry Group
Memphis, Tennessee 38111
United StatesSite Not Available
Total Eye Care
Memphis, Tennessee 38119
United StatesSite Not Available
United States
Memphis, Tennessee 38119
United StatesSite Not Available
United States
Goodlettsville 4625282, Tennessee 4662168 37072
United StatesSite Not Available
United States
Memphis 4641239, Tennessee 4662168 38119
United StatesSite Not Available
Whitsett Vision Group
Houston, Texas 77055
United StatesSite Not Available
Lake Travis Eye and Laser Center/ Revolution Research
Lakeway, Texas 78738
United StatesSite Not Available
Red River Research Partners
Richardson, Texas 75080
United StatesSite Not Available
Parkhurst NuVision
San Antonio, Texas 78229
United StatesSite Not Available
United States
San Antonio, Texas 78229
United StatesSite Not Available
United States
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Eye Institute of Utah
Salt Lake City, Utah 84107
United StatesSite Not Available

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