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

Information source: Ocularis Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Night Vision Complaints

Intervention: Phentolamine mesylate ophthalmic solution (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ocularis Pharma Inc.

Summary

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.

Clinical Details

Official title: Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Complaints

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution...

Secondary outcome:

Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution ...

Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution

Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution

Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution

Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution

Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution

Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

Celerion, Phoenix, Arizona 67230, United States
Additional Information

Starting date: October 2011
Last updated: October 9, 2012

Page last updated: August 23, 2015

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