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Sponsor undergoing financial hardships - no longer able to support trial; no safety concerns.
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| Name | Class |
|---|---|
| IQVIA Biotech | INDUSTRY |
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The primary objective is to determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED). After 8 weeks of randomized, double-blind treatment, non-healers will enter into an additional 8-week open-label ST266 treatment period. All patients will be followed for 3-months post-treatment for monitoring of safety and maintenance of re-epithelialization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST266 | Experimental | Topical ocular application: one drop in the study eye four times a day for 8 weeks |
|
| Placebo | Placebo Comparator | Topical ocular application: one drop in the study eye four times a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST266 | Biological | Topical ocular application: one drop four times a day for eight weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Proportion of subjects with clinical success between ST266 and placebo arms, defined as complete re-epithelialization of the corneal epithelial defect by week 8 of treatment. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of ST266 | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in subjects treated with ST266 versus placebo | 7 months |
| Time to re-epithelialization | Time (in days) to first complete re-epithelization of PED in subjects treated with ST266 versus placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Research Group | Dothan | Alabama | 36301 | United States | ||
| University of Arkansas for Medical Sciences |
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Randomized, Double-Blind, Placebo-Controlled trial with Open-Label Extension
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| 0.67% Sodium Chloride Ophthalmic Solution |
| Other |
Topical ocular application: one drop four times a day for eight weeks |
|
|
| Open-label ST266 | Biological | Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks |
|
| 8 weeks |
| Maintenance of re-epithelialization during treatment | Time (in days) of re-epithelialization maintenance during treatment. | 8 weeks |
| Maintenance of re-epithelialization post-treatment | Maintenance of corneal re-epithelization at 2 weeks and up to 12 weeks after the end of treatment in subjects treated with ST266 versus placebo. | 12 weeks |
| Change in BCVA from Baseline | Mean change in Best Corrected Visual Acuity (BCVA) from Baseline over time and maintenance up to 12 weeks after the end of treatment in subjects treated with ST266 versus placebo. | 7 months |
| Incidence of Rescue Therapy | Incidence of need for rescue within 8 weeks in subjects treated with ST266 versus placebo. | 8 weeks |
| Clinical Success in Open-Label Extension | Proportion of subjects with complete re-epithelization of the corneal epithelial defect after 8 weeks of open label treatment based on the Independent Reading Center (IRC) image assessment. | 8 weeks |
| Use of Lubricating Drops | Mean usage of preservative-free lubricating drops used for comfort in subjects treated with ST266 versus placebo. | 8 weeks |
| VAS Score | Mean change in Visual Analog Scale (VAS) score from Baseline over time in subjects treated with ST266 versus placebo. | 8 weeks |
| Size of Defect | Size of epithelial defect | 7 months |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Atlantis Eye Care | Huntington Beach | California | 92647 | United States |
| UCLA Stein Eye Institute | Los Angeles | California | 90095 | United States |
| Stanford | Palo Alto | California | 94303 | United States |
| UCLA Doheny Eye Center | Pasadena | California | 91105 | United States |
| California Eye Specialists Medical Group | Pasadena | California | 91107 | United States |
| Bowden Eye & Associates | Jacksonville | Florida | 32259 | United States |
| Shettle Eye Research | Largo | Florida | 33733 | United States |
| Millennium Clinical Research, Inc | Miami | Florida | 33125 | United States |
| MedEye Associates | Miami | Florida | 33143 | United States |
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | United States |
| University of Maryland Eye Associates | Baltimore | Maryland | 21201 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts Eye and Ear | Boston | Massachusetts | 02114 | United States |
| Mercy Clinic Eye Specialists- Ophthalmology | Springfield | Missouri | 65804 | United States |
| UNMC Truhlsen Eye Institute | Omaha | Nebraska | 68105 | United States |
| UNC Kittner Eye Center | Chapel Hill | North Carolina | 27517 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| OSU Wexner Medical Center | Columbus | Ohio | 43212 | United States |
| Ophthalmic Partners, PC | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Blanton Eye Institute/Houston Methodist Eye Associates | Houston | Texas | 77030 | United States |
| Texas Eye Research Center | Hurst | Texas | 76054 | United States |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 34502 | United States |
| WVU Eye Institute | Morgantown | West Virginia | 26505 | United States |
| The Eye Centers of Racine and Kenosha | Kenosha | Wisconsin | 53142 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |