Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04638660
Other study ID # OPI-NYXDLD-301 (LYNX-1)
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 30, 2020
Est. completion date May 19, 2022

Study information

Verified date August 2023
Source Ocuphire Pharma, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date May 19, 2022
Est. primary completion date May 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Phentolamine Ophthalmic Solution 0.75%
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle (Placebo)
Topical sterile ophthalmic solution

Locations

Country Name City State
United States Clinical Site 20 Edgewood Kentucky
United States Clinical Site 4 Elizabeth City North Carolina
United States Clinical Site 2 Fargo North Dakota
United States Clinical Site 22 High Point North Carolina
United States Clinical Site 9 High Point North Carolina
United States Clinical Site 18 Jacksonville Florida
United States Clinical Site 3 Jacksonville Florida
United States Clinical Site 14 Louisville Kentucky
United States Clinical Site 11 Memphis Tennessee
United States Clinical Site 6 Newport Beach California
United States Clinical Site 19 Ogden Utah
United States Clinical Site 10 Palisades Park New Jersey
United States Clinical Site 8 Pennington New Jersey
United States Clinical Site 1 Petaluma California
United States Clinical Site 13 Pittsburg Kansas
United States Clinical Site 5 San Antonio Texas
United States Clinical Test 15 Warwick Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Ocuphire Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye 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 8 days
Secondary Percent of Subjects With mLCVA Improvement in Study Eye 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) up to 15 days
Secondary Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye 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 up to 15 days
Secondary Change From Baseline in Study Eye Mesopic Pupil Diameter (PD) Change from baseline in study eye mesopic PD up to 15 days
Secondary Percent Change From Baseline in Study Eye Mesopic Pupil Diameter (PD) Percent change from baseline in study eye mesopic PD up to 15 days