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出境医 / 临床实验 / Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

Study Description
Brief Summary:

The objectives of this study are:

  • To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT).
  • To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle.
  • To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: Phentolamine Mesylate Ophthalmic Solution 1% Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) Phase 2

Detailed Description:
Placebo-controlled double-masked, multiple dose Phase 2 study in 40 patients with IOP ≥ 22 and ≤30 mmHg, evaluating ocular and systemic safety and efficacy following administration of Phentolamine mesylate 1.0% QD at 8PM to 10PM in both eyes for 14 days.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : May 28, 2019
Actual Primary Completion Date : September 11, 2019
Actual Study Completion Date : September 11, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Nyxol Ophthalmic Solution 1%
1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
 Drug: Phentolamine Mesylate Ophthalmic Solution 1%
Topical Sterile Ophthalmic Solution
Other Name: Nyxol®
Placebo Comparator: Nyxol Ophthalmic Solution Vehicle
1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
 Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Topical Sterile Ophthalmic Solution
Outcome Measures
Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 14 days ]
    change from Baseline in mean diurnal IOP in the study eye


Secondary Outcome Measures :
  1. Distance Visual Acuity [ Time Frame: 14 days ]
    Change in Distance Visual Acuity from Baseline measured at 4 meters (photopic and mesopic)

  2. Near Visual Acuity [ Time Frame: 14 days ]
    Change in Near Visual Acuity from Baseline measured at 16 inches (photopic and mesopic)

  3. Pupil Diameter [ Time Frame: 14 days ]
    Change and percent change from Baseline in Pupil Diameter (mesopic and photopic)

  4. Conjunctival Hyperemia [ Time Frame: 14 days ]
    Change in Conjunctival Hyperemia score


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

Inclusion Criteria:

  1. 18 years of age or greater
  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). A reported history of untreated OHT with IOP ≥22mmHg and ≤ 30mmHg is preferred.
  3. Untreated or treated OAG/OHT with 2 or fewer ocular hypotensive medications.
  4. Untreated (post-washout) mean IOP ≥ 22mmHg and ≤30mmHg in the study eye at the Qualification Visit (8AM).
  5. Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200 or better) at the Screening Visit and Qualification Visit.
  6. Otherwise healthy and well-controlled subjects.
  7. Able and willing to give signed informed consent and follow study instructions.
  8. Able to self-administer study medication or to have study medication administered by a caregiver throughout the study period.

Exclusion Criteria:

  1. Closed or very narrow angles (Grade 0-1, Shaffer)
  2. Glaucoma: pseudo-exfoliation or pigment dispersion component
  3. Known hypersensitivity to any α-adrenoceptor antagonists
  4. Previous laser and/or non-laser glaucoma surgery or procedure in either eye
  5. Refractive surgery in either eye
  6. Ocular trauma in either eye within the 6 months prior to Screening, or ocular surgery or non-refractive laser treatment within the 3 months prior to Screening
  7. Recent or current evidence of ocular infection or inflammation in either eye
  8. Ocular medication in either eye of any kind within 30 days of Screening
  9. Clinically significant ocular disease in either eye
  10. History of diabetic retinopathy
  11. Contact lens wear within 3 days prior to and for the duration of the study
  12. Central corneal thickness in either eye >600 μm at Screening
  13. Any abnormality in either eye preventing reliable applanation tonometry
  14. Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
  15. Clinically significant systemic disease that might interfere with the study
  16. Participation in any investigational study within 30 days prior to Screening
  17. Use of any topical or systemic adrenergic or cholinergic drugs up to 30 days prior to Screening, or during the study
  18. Changes in systemic medication that could have an effect on IOP within 30 days prior to Screening
  19. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  20. Resting heart rate outside the normal range (50-110 beats per minute) at Screening or Qualification Visit
  21. Hypertension with resting diastolic blood pressure (BP) > 105 mmHg or systolic BP > 160 mmHg at the Screening or Qualification Visit
Contacts and Locations

Locations
Layout table for location information
United States, California
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
United States, Georgia
Clayton Eye Clinical Research
Morrow, Georgia, United States, 30260
United States, Michigan
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
United States, New York
Rochester Ophthalmological Group
Rochester, New York, United States, 14618
United States, Ohio
Abrams Eye Center
Cleveland, Ohio, United States, 44115
Sponsors and Collaborators
Ocuphire Pharma, Inc.
Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE May 28, 2019
Actual Primary Completion Date September 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		Intraocular Pressure [ Time Frame: 14 days ]
change from Baseline in mean diurnal IOP in the study eye
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Distance Visual Acuity [ Time Frame: 14 days ]
    Change in Distance Visual Acuity from Baseline measured at 4 meters (photopic and mesopic)
  • Near Visual Acuity [ Time Frame: 14 days ]
    Change in Near Visual Acuity from Baseline measured at 16 inches (photopic and mesopic)
  • Pupil Diameter [ Time Frame: 14 days ]
    Change and percent change from Baseline in Pupil Diameter (mesopic and photopic)
  • Conjunctival Hyperemia [ Time Frame: 14 days ]
    Change in Conjunctival Hyperemia score
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Distance Visual Acuity [ Time Frame: 14 days ]
    Change in Distance Visual Acuity from Baseline measured at 4 meters (photopic and mesopic)
  • Near Visual Acuity [ Time Frame: 14 days ]
    Change in Near Visual Acuity from Baseline measured at 16 inches (photopic and mesopic)
  • Pupil Diameter [ Time Frame: 14 days ]
    Change and percent change from Baseline in Pupil Diameter (mesopic and photopic)
  • Adverse Events [ Time Frame: 14 days ]
    Safety and Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
Official Title  ICMJE Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
Brief Summary

The objectives of this study are:

  • To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT).
  • To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle.
  • To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.
Detailed Description Placebo-controlled double-masked, multiple dose Phase 2 study in 40 patients with IOP ≥ 22 and ≤30 mmHg, evaluating ocular and systemic safety and efficacy following administration of Phentolamine mesylate 1.0% QD at 8PM to 10PM in both eyes for 14 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Phentolamine Mesylate Ophthalmic Solution 1%
    Topical Sterile Ophthalmic Solution
    Other Name: Nyxol®
  • Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
    Topical Sterile Ophthalmic Solution
Study Arms  ICMJE
  • Experimental: Nyxol Ophthalmic Solution 1%
    1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
    Intervention: Drug: Phentolamine Mesylate Ophthalmic Solution 1%
  • Placebo Comparator: Nyxol Ophthalmic Solution Vehicle
    1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
    Intervention: Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2019) 		39
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		40
Actual Study Completion Date  ICMJE September 11, 2019
Actual Primary Completion Date September 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years of age or greater
  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). A reported history of untreated OHT with IOP ≥22mmHg and ≤ 30mmHg is preferred.
  3. Untreated or treated OAG/OHT with 2 or fewer ocular hypotensive medications.
  4. Untreated (post-washout) mean IOP ≥ 22mmHg and ≤30mmHg in the study eye at the Qualification Visit (8AM).
  5. Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200 or better) at the Screening Visit and Qualification Visit.
  6. Otherwise healthy and well-controlled subjects.
  7. Able and willing to give signed informed consent and follow study instructions.
  8. Able to self-administer study medication or to have study medication administered by a caregiver throughout the study period.

Exclusion Criteria:

  1. Closed or very narrow angles (Grade 0-1, Shaffer)
  2. Glaucoma: pseudo-exfoliation or pigment dispersion component
  3. Known hypersensitivity to any α-adrenoceptor antagonists
  4. Previous laser and/or non-laser glaucoma surgery or procedure in either eye
  5. Refractive surgery in either eye
  6. Ocular trauma in either eye within the 6 months prior to Screening, or ocular surgery or non-refractive laser treatment within the 3 months prior to Screening
  7. Recent or current evidence of ocular infection or inflammation in either eye
  8. Ocular medication in either eye of any kind within 30 days of Screening
  9. Clinically significant ocular disease in either eye
  10. History of diabetic retinopathy
  11. Contact lens wear within 3 days prior to and for the duration of the study
  12. Central corneal thickness in either eye >600 μm at Screening
  13. Any abnormality in either eye preventing reliable applanation tonometry
  14. Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
  15. Clinically significant systemic disease that might interfere with the study
  16. Participation in any investigational study within 30 days prior to Screening
  17. Use of any topical or systemic adrenergic or cholinergic drugs up to 30 days prior to Screening, or during the study
  18. Changes in systemic medication that could have an effect on IOP within 30 days prior to Screening
  19. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  20. Resting heart rate outside the normal range (50-110 beats per minute) at Screening or Qualification Visit
  21. Hypertension with resting diastolic blood pressure (BP) > 105 mmHg or systolic BP > 160 mmHg at the Screening or Qualification Visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960866
Other Study ID Numbers  ICMJE OPI-NYXG-201 (ORION-1)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ocuphire Pharma, Inc.
Study Sponsor  ICMJE Ocuphire Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ocuphire Pharma, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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