ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03687632|
Recruitment Status : Active, not recruiting
First Posted : September 27, 2018
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Persistent Corneal Epithelial Defect||Biological: ST266||Phase 2|
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.
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 (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a Phase 2, open label trial to determine if treatment with ST266 eye drops for 28 days heals the study eye.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open Label Trial of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Single arm - active
ST266 eye drops given to the study eye for 28 days (112 doses total will be administered).
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).
- Proportion of subjects with complete healing of PED during 28 days of treatment starting [ Time Frame: 28 days ]Healing is defined as the complete re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.
- Safety endpoint of the incidence of adverse and serious adverse events [ Time Frame: 28 days ]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.
- Percent of subjects with complete healing within 14 days of starting treatment [ Time Frame: 14 days ]Healing is defined as the complete re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.
- Time (in days) to complete re-epithelialization of the study eye [ Time Frame: This assessment will occur during clinic visits on days 4, 8, 11, 15, 22 and 29. ]Re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.
- Persistence of complete corneal re-epithelialization in the study eye [ Time Frame: The measurement will be made 7 days after end of treatment (at end of study visit). ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687632
|United States, Indiana|
|Price Vision Group|
|Indianapolis, Indiana, United States, 46260|
|United States, Kentucky|
|Cincinnati Eye Institute|
|Edgewood, Kentucky, United States, 41017|
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Univesity of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, West Virginia|
|University of West Virginia|
|Morgantown, West Virginia, United States, 26506|