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Novel Dexamethasone Sodium Phosphate Treatment (DSP-Visulex) for Noninfectious Anterior Uveitis: A Randomized Phase I/II Clinical Trial
- Source :
- Current eye research. 44(2)
- Publication Year :
- 2018
-
Abstract
- Frequent steroid drops represent a challenge in patient compliance. This study evaluated the safety and efficacy of 5 minute topical dexamethasone sodium phosphate-Visulex (DSP-Visulex) treatment regimen (two applications on the first week then weekly after) compared to daily prednisolone acetate 1% (PA) for noninfectious anterior uveitis.Forty-four patients were randomized to 8% DSP-Visulex with placebo eye drops (8% group, n = 14), 15% DSP-Visulex with placebo eye drops (15% group, n = 15), or Vehicle-Visulex with PA eye drops (PA group, n = 15). Patients received daily eye drops and Visulex treatments on days 1, 3, 8, and 15 with an optional treatment on day 22. Efficacy measures were change in anterior chamber cell (ACC) count from baseline and proportion of patients with zero ACC count at days 8, 15, and 29. Safety measures were adverse events (AEs), visual acuity, ocular symptoms, and intraocular pressure (IOP).ACC resolution over time was similar among the three groups. The percentage of patients with clear ACC was 18%, 22%, and 15% on day 8; 27%, 56%, and 54% on day 15; and 90%, 88%, and 77% on day 29 for the 8%, 15%, and PA groups, respectively. The numbers of reported AEs were 10, 36, and 12 for the 8%, 15%, and PA groups, respectively. Ten patients among all groups experienced treatment-related AEs, which included headache, eye pain, corneal abrasion, conjunctival/corneal staining, conjunctivitis, visual acuity reduction, and keratitis all of which were resolved during the timeframe of patients' participation in the study. IOP elevation was noted in the PA group throughout the study, whereas IOP elevation in the DSP-Visulex groups was observed at day 3 but not thereafter.The efficacy of the DSP-Visulex applications was comparable to the daily PA drops in the treatment of noninfectious anterior uveitis. Both 8% and 15% DSP-Visulex treatments were safe and well tolerated.
- Subjects :
- Adult
Male
Anterior Chamber
medicine.medical_treatment
Sodium
Administration, Topical
Visual Acuity
chemistry.chemical_element
Cell Count
Slit Lamp Microscopy
Dexamethasone
Steroid
03 medical and health sciences
Cellular and Molecular Neuroscience
Young Adult
0302 clinical medicine
Dexamethasone Sodium Phosphate
stomatognathic system
Double-Blind Method
medicine
Humans
Glucocorticoids
Intraocular Pressure
Aged
Retrospective Studies
Dose-Response Relationship, Drug
business.industry
Middle Aged
medicine.disease
Uveitis, Anterior
Sensory Systems
Clinical trial
Ophthalmology
Phase i ii
Treatment Outcome
chemistry
Anesthesia
030221 ophthalmology & optometry
Female
Anterior uveitis
Ophthalmic Solutions
business
030217 neurology & neurosurgery
Uveitis
medicine.drug
Follow-Up Studies
Subjects
Details
- ISSN :
- 14602202
- Volume :
- 44
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Current eye research
- Accession number :
- edsair.doi.dedup.....e1f11ac0e406bfa5c9762bac2fda31f8