Who is sponsoring NCT01703559?

NCT01703559 is sponsored by Ocuphire Pharma, Inc..

What drugs are being tested in NCT01703559?

Interventions in NCT01703559: Phentolamine Mesylate Ophthalmic Solution 1.0%, Phentolamine Mesylate Ophthalmic Solution 0.5%, Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo).

What condition does NCT01703559 study?

NCT01703559 studies Night Vision Complaints, Decrease in Night Vision, Disturbance; Vision, Loss.

Is NCT01703559 still recruiting?

NCT01703559 is currently completed. Last updated 1 August 2019.

Last reviewed 2019-08-01 · How we verify

NCT01703559

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 1 August 2019

What this trial tests

Phase 2 trial testing Phentolamine Mesylate Ophthalmic Solution 1.0% in Night Vision Complaints in 60 participants. Completed in 30 April 2012.

Timeline

9 September 2011

Primary endpoint
16 April 2012

30 April 2012

Quick facts

Lead sponsor	Ocuphire Pharma, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	9 September 2011
Primary completion	16 April 2012
Estimated completion	30 April 2012
Sites	1 location across United States

Drugs / interventions tested

Phentolamine Mesylate Ophthalmic Solution 1.0% — full drug profile →
Phentolamine Mesylate Ophthalmic Solution 0.5% — full drug profile →
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Conditions studied

Night Vision Complaints — all drugs for Night Vision Complaints →
Decrease in Night Vision — all drugs for Decrease in Night Vision →
Disturbance; Vision, Loss — all drugs for Disturbance; Vision, Loss →

Sponsor

Ocuphire Pharma, Inc. — full company profile →

Who can join

Adults 18 to 45, any sex, with Night Vision Complaints or Decrease in Night Vision. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Presbyopic Glaucoma Patients in a Randomized Phase 2b Clinical Trial.
Pepose JS, Hartman PJ, DuBiner HB, Abrams MA, et al · · 2021 · cited 6× · PMID 33447013 · DOI 10.2147/opth.s278169

Verify or expand the search:

Other Ocuphire Pharma, Inc. trials

Trials by the same sponsor.

NCT06542497 — Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia · Phase 3 · completed
NCT06349759 — Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbanc · Phase 3 · completed
NCT05646719 — Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects · Phase 3 · completed
NCT05223478 — Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects · Phase 3 · completed
NCT05134974 — Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MI · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01703559 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ocuphire Pharma, Inc.
Last refreshed: 1 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01703559.

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