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The objectives of this study are:
To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nyxol + Pilocarpine | Experimental | 1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2) |
|
| Nyxol | Active Comparator | 1 drop of Nyxol (Treatment 1) |
|
| Pilocarpine | Active Comparator | 1 drop of Pilocarpine (Treatment 2) |
|
| Placebo | Placebo Comparator | 1 drop of Placebo (Treatment 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentolamine Ophthalmic Solution 0.75% | Drug | 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1). | Visit 2 at 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours | Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic (in either eye):
Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion.
Current use of any topical ophthalmic therapy for dry eye.
Tear break-up time of < 5 seconds or corneal fluorescein staining.
Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
Recent or current evidence of ocular infection or inflammation in either eye.
Any history of herpes simplex or herpes zoster keratitis.
History of diabetic retinopathy or diabetic macular edema.
Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
Unwilling or unable to discontinue use of contact lenses.
Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.
Systemic:
Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
Participation in any investigational study within 30 days prior to Screening.
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 specified range of 50 to 110 beats per minute.
Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site 12 | Laguna Hills | California | 92653 | United States | ||
| Clinical Site 6 |
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| ID | Title | Description |
|---|---|---|
| FG000 | POS 0.75% First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2020 | Jun 23, 2023 |
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| Pilocarpine | Drug | Pilocarpine ophthalmic solution |
|
| Placebo | Other | Topical sterile ophthalmic solution |
|
|
| Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with < 5 letters of loss in photopic binocular BCDVA from Baseline | Visit 2 at 1 hour |
| Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters | Visit 2 at 1 hour, at 3 hours, and at 6 hours |
| Newport Beach |
| California |
| 92663 |
| United States |
| Clinical Site 13 | Crystal River | Florida | 34461 | United States |
| Clinical Site 5 | Longwood | Florida | 32779 | United States |
| Clinical Site 11 | Maitland | Florida | 32751 | United States |
| Clinical Site 8 | Sarasota | Florida | 34239 | United States |
| Clinical Site 10 | Roswell | Georgia | 30041 | United States |
| Clinical Site 3 | Pittsburg | Kansas | 66762 | United States |
| Clinical Site 18 | St Louis | Missouri | 63101 | United States |
| Clinical Site 16 | Poughkeepsie | New York | 12603 | United States |
| Clinical Site 14 | Fargo | North Dakota | 58103 | United States |
| Clinical Site 2 | Athens | Ohio | 45701 | United States |
| Clinical Site 9 | Cincinnati | Ohio | 45242 | United States |
| Clinical Site 7 | Cleveland | Ohio | 44115 | United States |
| Clinical Site 15 | Powell | Ohio | 43065 | United States |
| Clinical Site 4 | Warwick | Rhode Island | 02888 | United States |
| Clinical Site 1 | Memphis | Tennessee | 38119 | United States |
| FG001 | POS 0.75% First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| FG002 | POS Vehicle First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| FG003 | POS Vehicle First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | POS 0.75% First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| BG001 | POS 0.75% First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| BG002 | POS Vehicle First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| BG003 | POS Vehicle First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Study eye, n (%) | Count of Participants | Participants |
| ||||||||||||||||
| Iris color, n (%) | Count of Participants | Participants |
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| Irides type, n (%) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline photopic BCDVA study eye, letters read | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline photopic BCDVA fellow eye | Mean | Standard Deviation | letters read at 4 m distance |
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| Baseline photopic BCDVA binocular | Mean | Standard Deviation | letters read at 4 m distance |
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| Baseline mesopic BCDVA study eye | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline mesopic BCDVA fellow eye | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline mesopic BCDVA binocular | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline photopic DCNVA study eye | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline photopic DCNVA fellow eye | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline photopic DCNVA binocular | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline mesopic DCNVA study eye | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline mesopic DCNVA fellow eye | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline mesopic DCNVA binocular | Mean | Standard Deviation | letters read at 4 m distance |
| |||||||||||||||
| Baseline photopic DCIVA study eye | Mean | Standard Deviation | letters read |
| |||||||||||||||
| Baseline photopic DCIVA fellow eye | Mean | Standard Deviation | letters read |
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| Baseline photopic DCIVA binocular | Mean | Standard Deviation | letters read |
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| Baseline photopic PD study eye | Mean | Standard Deviation | mm |
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| Baseline photopic PD fellow eye | Mean | Standard Deviation | mm |
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| Baseline mesopic PD study eye | Mean | Standard Deviation | mm |
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| Baseline mesopic PD fellow eye | Mean | Standard Deviation | mm |
| |||||||||||||||
| Baseline IOP study eye | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Baseline IOP fellow eye | Mean | Standard Deviation | mmHg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1). | Posted | Number | percentage of subjects with ≥ 15 letters | Visit 2 at 1 hour |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours | Posted | Number | percentage of subjects with improvement | Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with < 5 letters of loss in photopic binocular BCDVA from Baseline | Posted | Number | % of subjects with improvement | Visit 2 at 1 hour |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters | Posted | Number | percentage with improvement | Visit 2 at 1 hour, at 3 hours, and at 6 hours |
|
9 days.
Data is not provided for each intervention separately as analyses by specific intervention were not conducted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POS 0.75% First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. | 0 | 44 | 0 | 44 | 15 | 44 |
| EG001 | POS 0.75% First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. | 0 | 30 | 0 | 30 | 6 | 30 |
| EG002 | POS Vehicle First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. | 0 | 31 | 0 | 31 | 6 | 31 |
| EG003 | POS Vehicle First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. | 0 | 45 | 0 | 45 | 2 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site erythema | General disorders | Systematic Assessment |
| ||
| Installation site pain | General disorders | Systematic Assessment |
| ||
| Installation site pruritus | General disorders | Systematic Assessment |
| ||
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Corneal dystrophy | Eye disorders | Systematic Assessment |
| ||
| Eye irritation | Eye disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Eye pruritus | Eye disorders | Systematic Assessment |
| ||
| Foreign body sensation in eyes | Eye disorders | Systematic Assessment |
| ||
| Lacrimation increased | Eye disorders | Systematic Assessment |
| ||
| Visual acuity reduced | Eye disorders | Systematic Assessment |
| ||
| Dysgeusia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intraocular pressure increased | Investigations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drey Coleman | Ocuphire Pharma, Inc. | 8134041993 | dcoleman@ocuphire.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2021 | Jun 22, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010862 | Pilocarpine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OS |
|
| Dark blue |
|
| Blue with peripupillary brown |
|
| Uniform green |
|
| Green with brown iris ring |
|
| Central brown and peripheral green |
|
| Brown with some peripheral green |
|
| Brown |
|
| Dark |
|
| OG002 | POS Vehicle First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| OG003 | POS Vehicle First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
|
|
| OG002 | POS Vehicle First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| OG003 | POS Vehicle First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
|
|
| OG002 | POS Vehicle First, Then LDP 0.4% | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2. Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
| OG003 | POS Vehicle First, Then LDP Vehicle | Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2. Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2. Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. |
|
|