CompletedPhase 2

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

United States60 participantsStarted 2011-09-09

Plain-language summary

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

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18 to 45 years of age experiencing severe night vision difficulty (as reported subjectively)
✓. 0.3 log improvement at least 1 eye using the Holladay Automated Contrast Sensitivity System (HACSS™) test at 2 of 4 spatial frequencies (3, 6, 12, and 18 cycles per degree) under low and high mesopic room illumination with glare
✓. Photopic visual acuity (corrected or uncorrected) of 20/25 or better
✓. Able and willing to give informed consent and comply with all protocol-mandated procedures

Exclusion criteria

✕. Cataracts (nuclear sclerosis or anterior subcapsular) of 1+ or greater
✕. Contact lens wear within 4 weeks of enrollment
✕. Ocular trauma within the past 6 months, or ocular surgery or laser treatment within the past 3 months
✕. Refractive surgery or cataract surgery in either eye
✕. Use of ocular medication within 4 weeks of Visit 1
✕. Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca, glaucoma, retinal degenerative disease) which might interfere with the study
✕. Any abnormality preventing reliable applanation tonometry of either eye
✕. Central corneal thickness greater than 600 µ

What they're measuring

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

Timeframe: Days 1, 4, 8, 15, and 32

Trial details

NCT IDNCT01703559

SponsorOcuphire Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-04-16

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