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Phase 2Completed

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

Double-Masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances

Sponsor
Ocuphire Pharma, Inc. (Industry)
Enrolment
60 enrolled
Conditions
Night Vision Complaints; Decrease in Night Vision; Disturbance; Vision, Loss
Interventions
Phentolamine Mesylate Ophthalmic Solution 1.0%; Phentolamine Mesylate Ophthalmic Solution 0.5%; Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Ages
adults
Registry
NCT01703559

Full record on ClinicalTrials.gov

From the registry

The objectives of this study are: * To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity * To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) compared to its vehicle, a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate

Primary outcomes

  • Proportion of Eyes With ≥ 0.3 Log Increase in Mesopic Contrast Sensitivities for at Least 2 HACSS Frequencies

History

  1. Results first posted

  2. Last registry update

  3. Registered

  4. Study completion

  5. Primary completion

  6. Started