Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light … (NCT04638660) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
United States144 participantsStarted 2020-12-30
Plain-language summary
The objectives of this study are:
* To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD)
* To evaluate efficacy of Nyxol to improve visual performance
* To evaluate the safety of Nyxol
Who can participate
Age range18 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
✓. Males or females ≥ 18 years of age
✓. Subject-reported DLD (likely subjects with a history of multifocal IOLs, post-laser-assisted in situ keratomileusis \[LASIK\], corneal scars, and keratoconus)
✓. Ability to comply with all protocol-mandated procedures independently and to attend all
✓. Otherwise healthy and well-controlled subjects
✓. Able and willing to give written consent to participate in this study
✓. Able to self-administer study medication
✓. PD ≥ 6 mm under mesopic conditions (prior to illumination) in at least one eye
✓. ≤ 20 (20/100 Snellen or worse) ETDRS letters in mLCVA score
Exclusion criteria
✕. Prior history of dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops occasionally for dry eye
✕. Prior history of fluctuating vision
✕. Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
✕. Known hypersensitivity to any topical alpha-adrenoceptor antagonists
✕. Known allergy or contraindication to any component of the vehicle formulation
What they're measuring
1
Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye