Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-02-29

Brief Summary

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The objectives of this study are:

* To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:

1. Contrast sensitivity
2. Low contrast visual acuity
3. Wavefront aberrometry
4. Subjective questionnaire
* To assess the safety of ophthalmic phentolamine mesylate

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Detailed Description

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Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.

Conditions

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Decrease in Night Vision Disturbance; Vision, Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Phentolamine Mesylate Ophthalmic Solution 1%

1 drop in each eye (QD) for one day.

Group Type EXPERIMENTAL

Phentolamine Mesylate Ophthalmic Solution 1%

Intervention Type DRUG

Topical Sterile Ophthalmic Solution

Phentolamine Mesylate Ophthalmic Solution Vehicle

1 drop in each eye (QD) for one day.

Group Type PLACEBO_COMPARATOR

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Intervention Type OTHER

Topical Sterile Ophthalmic Solution

Interventions

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Phentolamine Mesylate Ophthalmic Solution 1%

Topical Sterile Ophthalmic Solution

Intervention Type DRUG

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Topical Sterile Ophthalmic Solution

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients ≥ 18 years of age
2. Currently experiencing severe night vision difficulty as reported subjectively
3. At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare
4. Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye
5. Good general health
6. Written informed consent to participate in this trial
7. Ability to comply with all protocol mandated procedures and to attend all scheduled office visits

Exclusion Criteria

1. Patients with untreated cataracts grades 1-4
2. Patients who wear contact lenses
3. Less than 5 weeks post-refractive surgery (LASIK or PRK)
4. Less than 5 weeks post intraocular lens insertion
5. Low blood pressure (systolic \<120 mm Hg or diastolic \<80 mm Hg)
6. A history of heart rate abnormalities
7. Administration of any investigational drug within 30 days of study initiation
8. Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1
9. Use of any systemic alpha adrenergic antagonists (Appendix 1)
10. Known local or systemic hypersensitivity to adrenergic antagonists
11. For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No