The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Complaints

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ocularis Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01703559
First received: May 18, 2012
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

Night vision complaints such as glare, starburst and halo are often a result of peripheral corneal aberrations that cause light scatter when the pupil dilates in mesopic or scotopic conditions. Modest reductions in pupil size achieved pharmacologically may reduce the light scatter in dim light situations.


Condition Intervention Phase
Night Vision Complaints
Drug: Phentolamine mesylate ophthalmic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Complaints

Resource links provided by NLM:


Further study details as provided by Ocularis Pharma Inc.:

Primary Outcome Measures:
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution... [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the proportion of subjects with an increase of at least 0.3 log in mesopic contrast sensitivity with glare at two or more frequencies at 1.5, 3, 6, 12, and 18 cycles per degree, measured with the Holladay Automated Contrast Sensitivity System (HACSS™) methodology.


Secondary Outcome Measures:
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution ... [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ] [ Designated as safety issue: No ]
    Mesopic contrast sensitivity with glare - continuous analysis

  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ] [ Designated as safety issue: No ]
    Mesopic contrast sensitivity without glare

  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ] [ Designated as safety issue: No ]
    Mesopic low contrast visual acuity

  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ] [ Designated as safety issue: No ]
    Mesopic high contrast visual acuity

  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ] [ Designated as safety issue: Yes ]
    Photopic high contrast visual acuity

  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ] [ Designated as safety issue: No ]
    Pupil diameter

  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ] [ Designated as safety issue: Yes ]
    Ocular hyperemia


Enrollment: 60
Study Start Date: October 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo Drug: Phentolamine mesylate ophthalmic solution
Ophthalmic solution, one drop each eye x 15 days
Active Comparator: 0.5% Phentolamine Drug: Phentolamine mesylate ophthalmic solution
Ophthalmic solution, one drop each eye x 15 days
Active Comparator: 1.0% Phentolamine Drug: Phentolamine mesylate ophthalmic solution
Ophthalmic solution, one drop each eye x 15 days

Detailed Description:

A large number of people with acceptable uncorrected or best-corrected daytime vision can experience night vision complaints, whether they be people with 'night myopia', people with Intraocular Implants (IOLs), cortical cataracts, or people who have had refractive surgery. Many of these people have corneal or lenticular aberrations, either naturally occurring or surgically introduced. For these people, when the pupil dilates in dim light, some light rays are not focused on the retina, resulting in visual aberrations including glare, ghosting, halos and starburst. It has been proposed that a modest pharmacologic reduction of pupil size has the potential to mitigate these complications in many affected individuals. The purpose of the present study is to evaluate the sub-acute effect of two dose levels of PM on contrast sensitivity and visual acuity during 15 days of continuous therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 to 45 years of age experiencing severe night vision difficulty as reported subjectively
  2. 0.3 log improvement at least one eye using the Holladay Automated Contrast Sensitivity System (HACSS™) test at two of four spatial frequencies (3, 6, 12, and 18 Cycles per degree) under low and high mesopic room illumination with glare
  3. Photopic visual acuity (corrected or uncorrected) of 20/25 or better
  4. Able and willing to give informed consent and comply with all protocol mandated procedures

Exclusion Criteria:

Ophthalmic:

  1. Cataracts (nuclear sclerosis or anterior subcapsular) of 1+ or greater
  2. Contact lens wear within four weeks of enrollment
  3. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
  4. Refractive surgery or cataract surgery in either eye
  5. Use of ocular medication within 4 weeks of Visit 1
  6. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, glaucoma, retinal degenerative disease) which might interfere with the study.
  7. Any abnormality preventing reliable applanation tonometry of either eye.
  8. Central corneal thickness greater than 600 µ.
  9. Known hypersensitivity or contraindication to PM, or any component of the formulation, or to topical anesthetics.

    Systemic:

  10. Contraindications to phentolamine (including history of myocardial infarction, cerebrovascular spasm, cerebrovascular occlusion, coronary insufficiency, angina, or other evidence suggestive of coronary artery disease).
  11. Low blood pressure - systolic < 100 mm Hg or diastolic <60 mm Hg.
  12. A history of heart rate abnormalities, such as tachycardia or arrhythmias.
  13. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
  14. Use of any systemic alpha adrenergic antagonists up to 4 weeks prior to screening, or during the study (Appendix 4).
  15. Changes of systemic medication that could have a substantial effect on ocular autonomic pupil tone 4 weeks prior to screening, or anticipated during the study.
  16. Participation in any investigational study within the past 30 days.
  17. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative serum pregnancy test result at the screening examination and must not intend to become pregnant during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703559

Locations
United States, Arizona
Celerion
Phoenix, Arizona, United States, 67230
Sponsors and Collaborators
Ocularis Pharma Inc.
  More Information

No publications provided

Responsible Party: Ocularis Pharma Inc.
ClinicalTrials.gov Identifier: NCT01703559     History of Changes
Other Study ID Numbers: OP-NYX-01
Study First Received: May 18, 2012
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ocularis Pharma Inc.:
Glare
Starburst
Halos
Reduced contrast sensitivity

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions
Phentolamine
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015