Inclusion Criteria

• ≥18 years of age^1,2
• Subject-reported DLD (likely subjects with a history of multifocal IOLs, LASIK, corneal scars, and keratoconus)^1,2
• Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits^1,2
• Otherwise healthy and well-controlled subjects^1,2
• Able and willing to give written consent to participate in this study^1,2
• Able to self-administer study medication^1,2
• PD ≥5 mm under mesopic conditions (prior to illumination) in at least 1 eye²
• ≤30 (20/63 Snellen or worse) ETDRS letters in mLCVA score in at least 1 eye²
• ≥10 ETDRS letters (≥2 lines) improvement in mLCVA in at least 1 eye during illumination of the contralateral eye with a BAT system²

The use of MR-142 for Dim Light Disturbances is currently being investigated and its safety and efficacy have not been established.
BAT, Brightness Acuity Tester; DLD, dim light vision disturbances; ETDRS, Early Treatment Diabetic Retinopathy Study; IOL, intraocular lens; LASIK, laser-assisted in situ keratomileusis; mLCVA, mesopic low-contrast distance visual acuity; PD, pupil diameter.
1. https://clinicaltrials.gov/study/NCT04638660; 2. LYNX-1 Ocuphire Pharma, Inc. Data on file.

Exclusion Criteria

Ophthalmic:

• History of dry eye diagnosis, taking prescription drops or (occasionally) artificial tear drops for dry eye
• History of fluctuating vision
• Clinically significant ocular disease that might interfere with the study as deemed by the Investigator
• Known hypersensitivity to any topical alpha-adrenoceptor antagonists
• Known allergy or contraindication to any component of the vehicle formulation (placebo)
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
• Ocular trauma, ocular surgery (e.g., IOLs), or laser procedure (e.g., LASIK, PRK) within 6 months prior to screening
• Use of any topical prescription or OTC ophthalmic medications within 7 days of screening
• Recent or current evidence of ocular infection or inflammation in either eye^*
• History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration
• History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris
• Unwilling or unable to discontinue contact lens use at screening until study completion^†

The use of  MR-142 for Dim Light Disturbances is currently being investigated and its safety and efficacy have not been established.
^*Subjects must be symptom free for ≥7 days; ^†Except for keratoconus subjects who may wear contacts up to 24 hours prior to their scheduled visits.
IOL, intraocular lens; LASIK, laser-assisted in situ keratomileusis; OTC, over-the-counter; PRK, photorefractive keratectomy.
https://clinicaltrials.gov/study/NCT04638660.

Systemic:

• Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists
• Clinically significant systemic disease that might interfere with the study
• 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
• Participation in any investigational study within 30 days prior to screening and during the study
• Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
• Resting HR outside the range of ≤50 to ≥110 bpm
• Hypertension with resting DBP >105 mmHg or SBP >160 mmHg

The use of MR-142 for Dim Light Disturbances is currently being investigated and its safety and efficacy have not been established.
bpm, beats per minute; DBP, diastolic blood pressure; HR, heart rate; SBP, systolic blood pressure.
https://clinicaltrials.gov/study/NCT04638660.

Primary Endpoint

• Percentage of subjects with ≥15 ETDRS letters (≥3 lines) of improvement in the study eye in monocular mLCVA from baseline to day 8

The use of MR-142 for Dim Light Disturbances is currently being investigated and its safety and efficacy have not been established.
ETDRS, Early Treatment Diabetic Retinopathy Study; mLCVA, mesopic low-contrast distance visual acuity.
https://clinicaltrials.gov/study/NCT04638660.

Key Secondary Endpoints

• Percentage of subjects with ≥5, ≥10, and ≥15 ETDRS letters (≥1, ≥2, and ≥3 lines, respectively) improvement in the study eye in mLCVA from baseline to day 8* and day 15^1,2
• Percentage of subjects with ≥5, ≥10, and ≥15 ETDRS letters (≥1, ≥2, and ≥3 lines, respectively) improvement in the study eye in pLCVA and mHCVA from baseline to day 8 and day 15^1,2
• Change in mesopic PD in the study eye from baseline to day 8 and day 15^1,2
• Percentage of subjects with ≥5, ≥10, and ≥15 ETDRS letters (≥1, ≥2, and ≥3 lines, respectively) improvement in mesopic high-contrast DCNVA from baseline to day 8 and day 15²

The use of MR-142 for Dim Light Disturbances is currently being investigated and its safety and efficacy have not been established.
^*Excluding the primary endpoint.
DCNVA, distance-corrected near visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; mHCVA, mesopic high-contrast distance visual acuity; mLCVA, mesopic low-contrast distance visual acuity; PD, pupil diameter; pLCVA, photopic low-contrast distance visual acuity.
1. https://clinicaltrials.gov/study/NCT04638660; 2. LYNX-1 Ocuphire Pharma, Inc. Data on file.

Safety Endpoints

• Conjunctival hyperemia
• Intraocular pressure (IOP)
• Biomicroscopy
• Ophthalmoscopy
• Dry eye measurements
• Systemic safety as measured by HR and BP