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Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances
NCT01703559Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2011
- Primary completion
- Apr 2012
- Countries
- 1
- Sponsor
- Opus Genetics
- Modality
- Small Molecules
- Drugs
- phentolamine
01
Overview
Phase 2, randomised, double-blind trial of phentolamine (3 arms), sponsored by Opus Genetics. Primary endpoint: Proportion of Eyes With ≥ 0.3 Log Increase in Mesopic Contrast Sensitivities for at Least 2 HACSS Frequencies at Day 15. Started Sep 2011; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Phentolamine Mesylate Ophthalmic Solution Vehicle once daily for 15 days
Phentolamine Mesylate 0.5%
Phentolamine Mesylate Ophthalmic Solution 0.5% once daily for 15 days
Phentolamine Mesylate 1.0%
Phentolamine Mesylate Ophthalmic Solution 1.0% once daily for 15 days
03
Who it enrols
Adults 18-45 with severe night vision difficulty, specific contrast sensitivity improvement criteria, and photopic visual acuity of 20/25 or better. Excludes patients with cataracts, recent contact lens wear, ocular trauma/surgery, clinically significant ocular or systemic diseases, low blood pressure, and heart rate abnormalities.
04
Endpoints
Primary
Proportion of Eyes With ≥ 0.3 Log Increase in Mesopic Contrast Sensitivities for at Least 2 HACSS Frequencies
Secondary
Pupil Diameter - Change From Day 1 Pre-Dose Baseline
Mean Mesopic Contrast Sensitivity With Glare at Frequencies of 1.5, 3, 6, 12, and 18 Cycles Per Degree
Mesopic Contrast Sensitivity Without Glare at 1 or More Frequencies at 1.5, 3, 6, 12, and 18 Cycles Per Degree
Mesopic Distance High Contrast Visual Acuity (HCVA)
Mesopic Distance Low Contrast Visual Acuity (LCVA)
Subjective Evaluations of Vision (NEI Vision Function)
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