Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Su… (NCT06349759) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances
United States200 participantsStarted 2024-04-01
Plain-language summary
Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.
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
✓. Previous history of refractive surgery (eg, PRK, LASIK, SMILE, and RK) and have subject-reported night vision disturbances (eg, glare, halos, and/or starbursts). Symptoms must have been first noted within 2 months following refractive surgery
✓. Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits
✓. Able and willing to give written consent to participate in this study
✓. Able to self-administer study medication
✓. PD ≥ 5 mm under mesopic conditions in at least 1 eye. This test may be repeated once, following an additional 5 min of dark adaptation to the mesopic light conditions if the initial results do not meet this criterion
✓. mLCVA ≤ 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/63 Snellen or worse) in at least 1 eye using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m
✓. ≥ 10 ETDRS letters improvement in mLCVA in at least 1 eye during illumination of the contralateral eye with a Brightness Acuity Tester (BAT) system on the low setting using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m
Exclusion criteria
✕. Prior unresolved dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops routinely for dry eye
✕. Prior history of fluctuating vision
What they're measuring
1
Percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 15
✕. Clinically significant ocular disease as deemed by the Investigator (eg, untreated visually significant cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca, retina degeneration, loss of visual field due to glaucoma or stroke, branch retinal vein occlusion, retina flare) that might interfere with the study
✕. History or presence of corneal endothelial dystrophy (eg, Fuchs' dystrophy or presence of guttae)
✕. Known hypersensitivity to any topical alpha-adrenoceptor antagonists
✕. Known allergy or contraindication to any component of the vehicle formulation
✕. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
✕. Pseudophakic subjects with extended depth-of-focus or multifocal intraocular lenses (IOLs)