Ocuphire Pharma, Inc.

Reversal of Mydriasis Phase 2 Clinical Trial with Nyxol

About the Trial

Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis (NCT04024891)

Randomized, 2-arm cross-over, double-masked Phase 2b study in approximately 32 healthy subjects, evaluating safety and efficacy of Nyxol in subjects with pharmacologically induced mydriasis.

 At the first visit, subjects were screened for study eligibility.

 After screening, eligible subjects were randomized 1:1 to one of the two treatment sequences:

 Treatment sequence 1: Placebo (Visit 1), Nyxol (Visit 2).

 Treatment sequence 2: Nyxol (Visit 1), Placebo (Visit 2).

Randomization was stratified by mydriatic agent (2.5% phenylephrine or 1% tropicamide). Approximately one half of the randomized subjects received 2.5% phenylephrine and one half received 1% tropicamide. Subjects received their mydriatic agent 1 hour before treatment. Each subject received the same mydriatic agent throughout the study.

At each visit, pupil diameter (PD), accommodation, near and distance visual acuity (VA) and redness in each eye was measured before (-1 hour/baseline) and 1 hour after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e., right before the study treatment is administered), and at 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after treatment dosing. As needed, two hours post treatment, subjects were permitted to request the administration of Lumify® in the non-study eye.

Detailed Info

The objectives of this study are:* To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis * To evaluate the safety of Nyxol * To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol

Study Phase

Phase 2

Estimated Enrollment

32

Estimated Primary Completion Date

September 17, 2019

Study Type

Interventional

Interventions
  • Drug: Phentolamine Mesylate Ophthalmic Solution 1%
  • Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Sponsor

Ocuphire Pharma, Inc.

Location

The following cities were clinical trial sites. 

Eligibility

Inclusion Criteria

Inclusion Criteria

Gender
All 

Age
18 to 45 

  • Otherwise healthy and well controlled subjects
  • Able to comply with all protocol mandated procedures and to attend all scheduled office visits
  • Willing to give written informed consent to participate in this study

Exclusion Criteria

  • Clinically significant ocular disease as deemed by the Investigator (e.g., cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study
  • Unwilling or unable to discontinue use of contact lenses during treatment visits
  • Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
  • Ocular medication of any kind within 30 days of screening, with the exception of a) lid scrubs (which may have been used prior to, but not after screening) or b) lubricating drops for dry eye (preservative-free artificial tears), which may be used in between the study treatment days
  • Recent or current evidence of ocular infection or inflammation. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or herpes zoster keratitis at screening
  • History of diabetic retinopathy
  • Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated
  • History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris (e.g., irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy)
  • Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
  • Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists (e.g., 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 (CHF); severe diabetes)
  • Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine or cardiovascular disorders) that might interfere with the study
  • Initiation of treatment with or any changes to the current dosage, drug or regimen of any topical or systemic adrenergic or cholinergic drugs up to 7 days prior to screening, or during the study
  • Participation in any investigational study within 30 days prior to screening
  • Women 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 (IUD), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. An adult woman is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at Visit 1/Screening and Visit 2 examinations and must intend to not become pregnant during the study
  • Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit. HR may be repeated only once if outside the normal range following at least a 5-minute rest period in the sitting position
  • Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg at the Screening Visit. BP may be repeated only once if outside the specified range following at least a 5-minute rest period in the sitting position