Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances

Inclusion Criteria:

1. Males or females ≥ 18 years of age

2. Previous history of refractive surgery (eg, PRK, LASIK, SMILE, and RK) and havesubject-reported night vision disturbances (eg, glare, halos, and/or starbursts).Symptoms must have been first noted within 2 months following refractive surgery

3. Able to independently comply with all protocol-mandated procedures and to attend allscheduled office visits

4. Able and willing to give written consent to participate in this study

5. Able to self-administer study medication Inclusion criteria #6, #7, and #8 must all be met in the same eye:

6. PD ≥ 5 mm under mesopic conditions in at least 1 eye. This test may be repeatedonce, following an additional 5 min of dark adaptation to the mesopic lightconditions if the initial results do not meet this criterion

7. mLCVA ≤ 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/63 Snellenor worse) in at least 1 eye using the Precision Vision Illuminator Cabinet with 5%translucent contrast chart and a mesopic filter at 4 m

8. ≥ 10 ETDRS letters improvement in mLCVA in at least 1 eye during illumination of thecontralateral eye with a Brightness Acuity Tester (BAT) system on the low settingusing the Precision Vision Illuminator Cabinet with 5% translucent contrast chartand a mesopic filter at 4 m

Exclusion Criteria:

Ophthalmic (in either eye):

1. Prior unresolved dry eye diagnosis, taking prescription drops for dry eye, or takingartificial tear drops routinely for dry eye

2. Prior history of fluctuating vision

3. Clinically significant ocular disease as deemed by the Investigator (eg, untreatedvisually significant cataract, glaucoma, corneal edema, uveitis, severekeratoconjunctivitis sicca, retina degeneration, loss of visual field due toglaucoma or stroke, branch retinal vein occlusion, retina flare) that mightinterfere with the study

4. History or presence of corneal endothelial dystrophy (eg, Fuchs' dystrophy orpresence of guttae)

5. Known hypersensitivity to any topical alpha-adrenoceptor antagonists

6. Known allergy or contraindication to any component of the vehicle formulation

7. History of cauterization of the punctum or punctal plug (silicone or collagen)insertion or removal

8. Pseudophakic subjects with extended depth-of-focus or multifocal intraocular lenses (IOLs)

9. Ocular trauma, ocular surgery (eg, IOLs), or laser procedure (eg, LASIK, PRK, SMILE,and RK) within 6 months prior to Screening

10. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications ofany kind (including artificial tear drops) within 7 days prior to Screening untilstudy completion, with the exception of lid scrubs with OTC products (eg, OCuSOFT®lid scrub, SteriLid®, baby shampoo, etc.)

11. Recent or current evidence of ocular infection or inflammation (such as currentevidence of clinically significant blepharitis, conjunctivitis, or a history ofherpes simplex or herpes zoster keratitis at Screening). Subjects must be symptomfree for at least 7 days prior to Screening

12. History of diabetic retinopathy, diabetic macular edema, or dry or wet maculardegeneration

13. History of any traumatic (surgical or nonsurgical) or nontraumatic conditionaffecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupildisorder, iris atrophy, iridotomy, iridectomy, etc.)

14. 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

15. Previously undiagnosed dry eye, at the determination of the Investigator. Dry eyediagnosis should be based on one of the following dry eye test results: tearbreak-up time < 5 seconds, or corneal fluorescein staining ≥ Grade 2 in the inferiorzone or ≥ Grade 1 in the central zone using the National Eye Institute scale Systemic:

16. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptorantagonists (eg, chronic obstructive pulmonary disease or bronchial asthma;abnormally low BP or HR; second- or third-degree heart blockage or congestive heartfailure; or severe diabetes as defined below)

17. Predisposition to severe hypoglycemia (2 or more serious hypoglycemic episodesrequiring assistance within 12 months prior to Screening)

18. Any hospitalization or emergency room visit due to poor diabetic control within 6 months prior to Screening

19. Currently untreated diabetes mellitus or previously untreated subjects whoinitiated oral anti-diabetic medication or insulin within 3 months prior toScreening

20. Any sign of diabetic retinopathy in either eye

21. Clinically significant systemic disease (eg, severe diabetes as previously defined,myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders)that might interfere with the study

22. Initiation of treatment with or any changes to the current dosage, drug, or regimenof any systemic adrenergic or cholinergic drugs within 7 days prior to Screening orduring the study

23. Participation in any investigational study within 30 days prior to Screening orduring the study

24. Females of childbearing potential who are pregnant, nursing, planning a pregnancyduring the study, or not using a medically acceptable form of birth control.Acceptable methods include the use of at least one of the following: intrauterinedevice, hormonal (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 post-tuballigation must have a negative urine pregnancy test result at each visit

25. Resting HR outside 50 to 110 beats per min at Screening. HR may be repeated onlyonce if outside the specified range, following at least a 5-min rest period in thesitting position

26. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg atScreening. BP may be repeated only once if outside the specified range, following atleast a 5-min rest period in the sitting position