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Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances

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ClinicalTrials.gov Identifier: NCT04638660
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

Brief Summary:

The objectives of this study are:

  • To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD)
  • To evaluate efficacy of Nyxol to improve visual performance
  • To evaluate the safety of Nyxol

Condition or disease Intervention/treatment Phase
Dim Light Vision Disturbances Drug: Phentolamine Ophthalmic Solution 0.75% Drug: Phentolamine Ophthalmic Solution Vehicle (Placebo) Phase 3

Detailed Description:

Placebo-controlled, double-masked, multiple-dose, Phase 3 study in approximately 160 randomized subjects with DLD (approximately 136 that are evaluable for efficacy), evaluating safety and efficacy of Nyxol in subjects with DLD following administration of Nyxol once daily (QD) at or near bedtime (at 8PM to 10PM) in both eyes (OU) for 14 days.

Following the successful completion of screening, each subject will be stratified by iris color (light/dark irides) and will then be randomized to treatment (masked) 1:1, Nyxol or placebo (vehicle).

Treatment (Nyxol or placebo) will be administered in both eyes (OU) by the subjects at or near bedtime each day.

At the first visit subjects will be screened for study eligibility.

Treatment visits will occur 2 times: Day 8 (+1 day)/Visit 2 and Day 15 (+1 day)/Visit 3. mLCVA evaluations shall be performed on each of these days.

A follow-up visit (Visit 4) phone call will occur 1 to 3 days after Visit 3.

At select sites OPD Scan measurements will be made using wavefront abhermettry.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All subjects will be randomized into the study in a 1:1 ratio to one of the treatment arms (Nyxol or placebo), with a stratification by light/dark irides.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phentolamine Ophthalmic Solution 0.75%
One drop in both eyes at or near bedtime (8PM to 10PM)
Drug: Phentolamine Ophthalmic Solution 0.75%
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Other Names:
  • Nyxol
  • Nyxol®

Placebo Comparator: Phentolamine Ophthalmic Solution Vehicle
One drop in both eyes at or near bedtime (8PM to 10PM)
Drug: Phentolamine Ophthalmic Solution Vehicle (Placebo)
Topical sterile ophthalmic solution




Primary Outcome Measures :
  1. Percent of subjects with 3 lines mLCVA improvement in study eye [ Time Frame: 8 days ]
    Percent of subjects with ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (≥3 lines) of improvement in the study eye compared to baseline in monocular mLCVA at Day 8


Secondary Outcome Measures :
  1. Percent of subjects with mLCVA improvement [ Time Frame: up to 15 days ]
    Percent of subjects with ≥ 5, ≥ 10, and ≥ 15 ETDRS letters (≥ 1, ≥ 2, and ≥ 3 lines, respectively) improvement compared to baseline in mLCVA at Day 8 (excluding the primary endpoint)

  2. Percent of subjects with photopic low contrast visual acuity (pLCVA) and mHCVA improvement [ Time Frame: up to 15 days ]
    Percent of subjects with ≥ 5, ≥ 10, and ≥ 15 ETDRS letters (≥ 1, ≥ 2, and ≥ 3 lines, respectively) improvement compared to baseline in pLCVA and mHCVA at Day 8 and Day 15

  3. Change and percent change from baseline in mLCVA, pLCVA, mesopic high contrast visual acuity (mHCVA) and distance corrected near visual acuity (DCNVA) [ Time Frame: up to 15 days ]
    Change and percent change from baseline in mLCVA, pLCVA, mHCVA and DCNVA

  4. Change and percent change from baseline in pupil diameter (PD) [ Time Frame: up to 15 days ]
    Change and percent change from baseline in PD


Other Outcome Measures:
  1. Change and percent change in total RMS error and higher-order RMS [ Time Frame: up to 15 days ]
    Change and percent change from baseline in total RMS error (score) and higher-order RMS (spherical, coma, trefoil) error under mesopic conditions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females ≥ 18 years of age
  2. Subject-reported DLD (likely subjects with a history of multifocal IOLs, post-laser-assisted in situ keratomileusis [LASIK], corneal scars, and keratoconus)
  3. Ability to comply with all protocol-mandated procedures independently and to attend all
  4. Otherwise healthy and well-controlled subjects
  5. Able and willing to give written consent to participate in this study
  6. Able to self-administer study medication
  7. PD ≥ 6 mm under mesopic conditions (prior to illumination) in at least one eye
  8. ≤ 20 (20/100 Snellen or worse) ETDRS letters in mLCVA score

Exclusion Criteria:

Ophthalmic:

  1. Prior history of dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops occasionally for dry eye
  2. Prior history of fluctuating vision
  3. Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
  4. Known hypersensitivity to any topical alpha-adrenoceptor antagonists
  5. Known allergy or contraindication to any component of the vehicle formulation
  6. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
  7. Ocular trauma, ocular surgery (e.g., IOLs) or laser procedure (e.g., LASIK, photorefractive keratectomy [PRK]) within 6 months prior to screening
  8. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening
  9. Recent or current evidence of ocular infection or inflammation in either eye. Subjects must be symptom free for at least 7 days.
  10. History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration
  11. History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris
  12. Unwilling or unable to discontinue use of contact lenses at screening until study completion, except for keratoconus subjects who may wear contacts up to 24 hours prior to their scheduled visits

Systemic:

  1. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists
  2. Clinically significant systemic disease that might interfere with the study
  3. 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
  4. Participation in any investigational study within 30 days prior to screening and during the conduct of the study
  5. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  6. Resting HR outside the specified range (50-110 beats per minute)
  7. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638660


Contacts
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Contact: Drey Coleman 248-681-9815 dcoleman@ocuphire.com

Locations
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Sponsors and Collaborators
Ocuphire Pharma, Inc.
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Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04638660    
Other Study ID Numbers: OPI-NYXDLD-301 (LYNX-1)
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ocuphire Pharma, Inc.:
Nyxol, Night Vision Disturbances, Glare, Halos, Starbursts
Additional relevant MeSH terms:
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Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Phentolamine
Pharmaceutical Solutions
Ophthalmic Solutions
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents