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Completed
NCT06542497
Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia
Conditions: Presbyopia
Sex: All
Ages: 45 Years – 64 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 569
Sponsor: Ocuphire Pharma, Inc.
Location: Arizona Eye Center Chandler Arizona
Summary
Safety and efficacy of POS in participants with presbyopia
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following criteria:
1. Males or females ≥ 45 and ≤ 64 years of age
2. Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
3. Able and willing to give signed informed consent
4. Able to self-administer study medication throughout the study period
Inclusion criteria #5, #6, and #7 must all be met at both Screening and Baseline Visits:
5. BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20 Snellen equivalent) or better in photopic conditions in each eye
6. DCNVA of 50 ETDRS letters (20/50 Snellen equivalent) or worse but not \ 6 months prior to Screening
15. Monofocal IOL in place \> 6 months prior to Screening with any posterior capsule opacification
16. History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy, iridectomy, iritis, etc.)
17. Unwilling or unable to discontinue use of contact lenses at least 1 hour prior to Screening for soft contact lenses or at least 8 hours prior to Screening for hard gas permeable contact lenses, and at least 8 hours (for both types of lenses) prior to all other office visits
Systemic:
18. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists (eg, chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heart blockage or congestive heart failure)
19. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent
20. Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study as deemed by the judgment of the Investigator
21. Initiation of treatment with, or any changes to, the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to Screening or during the study; however, Flomax® (tamsulosin) is specifically excluded
22. Participation in any investigational study within 30 days prior to Screening
23. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. Acceptable methods include the use of at least one of the following: intrauterine device, hormonal contraception (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. A female is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential, including those with post-tubal ligation, must have a negative urine pregnancy test result at Visit 1 (Screening)
24. Resting HR outside the range of 50 to 110 beats per min (bpm) following at least a 5 min rest period in the sitting position at Visit 1 (Screening). HR may be repeated only once if outside the specified range, following another 5 min rest period in the sitting position
25. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg following 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, following another 5-min rest period in the sitting position
Source: ClinicalTrials.gov (NCT06542497). StuddyBuddy aggregates publicly available trial information.