The primary aim of the study is to evaluate the clinical response of ST266 treated subjects with persistent corneal epithelial defects during 28 days of therapy. The secondary endpoint is the response rate within 14 days of treatment.
Efficacy: The primary aim of the study is to evaluate the clinical response of ST266 treated subjects with persistent corneal epithelial defects during 28 days of therapy. The secondary endpoint is the response rate within 14 days of treatment. Failures are subjects that do not completely heal during 28 days of therapy. The epithelial defect can be of any size as long as it is measurable by slit lamp. The longest measurement and the measurement perpendicular to that will be determined and the area calculated. The change in area and perimeter of epithelial defect from baseline through Day 15 (14 days of treatment) and Day 29 (28 days of treatment) will be calculated for each subject. The time to complete re-epithelialization is defined as the time from the start of therapy (Baseline Visit/Day 1) to the Day when no defect is observed. The number and percent of responders and failures will be summarized at each visit. Graphical representation of percent of responders and failures will be provided. The change in area and perimeter of epithelial defect from baseline through Day 15 (14 days of treatment) and Day 29 (28 days of treatment) will be summarized. Visualization of mean (Standard Deviation) of the change in area and perimeter will be provided at each time point. The time to complete re-epithelialization will be summarized and listed. Safety: Subject demographics, baseline characteristics and relevant medical history will be summarized and listed. Data for ST266 administration and concomitant therapies will be listed. The number and percent of subjects with treatment emergent adverse events and ST266 related adverse events will be tabulated by system organ class and preferred terms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
1X ST266 applied in a dose of one drop (30-50 µL) in the study eye for 28 days (112 doses total will be administered).
Price Vision Group
Indianapolis, Indiana, United States
Cincinnati Eye Institute
Edgewood, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Proportion of subjects with complete healing of PED during 28 days of treatment starting
Healing is defined as the complete re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.
Time frame: 28 days
Safety endpoint of the incidence of adverse and serious adverse events
The secondary safety endpoint is the incidence of adverse and serious adverse events throughout the 28 days of treatment. For the safety evaluation, changes in visual acuity, IOP, and fluorescein staining will be considered as safety measures.
Time frame: 28 days
Percent of subjects with complete healing within 14 days of starting treatment
Healing is defined as the complete re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.
Time frame: 14 days
Time (in days) to complete re-epithelialization of the study eye
Re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.
Time frame: This assessment will occur during clinic visits on days 4, 8, 11, 15, 22 and 29.
Persistence of complete corneal re-epithelialization in the study eye
Corneal re-epithelialization in the study eye as determined by whether the healed epithelium remains intact after complete re-epithelialization is confirmed in the study eye, as determined by slit lamp examination with fluorescein staining.
Time frame: The measurement will be made 7 days after end of treatment (at end of study visit).
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Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Univesity of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of West Virginia
Morgantown, West Virginia, United States