Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo.
The variables to be evaluated include:
Primary (safety):
Primary (tolerability):
- Stinging
Secondary (safety):
Secondary (tolerability):
- Other ocular symptoms (foreign body sensation and tearing)
The operational definition states a difference under 15% in order to consider non inferior the safety and tolerability profile of PRO-232 compared to placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-232 | Experimental |
|
|
| Placebo | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-232 | Drug | Moxifloxacin 0.5% and Dexamethasone Phosphate 0.1% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Unexpected Related Adverse Reactions | Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention. | Days 0 (Basal Visit) 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call) |
| Changes in intraocular pressure (IOP) | Previous instillation of topical anesthetic, the IOP (right eye) will be measured through a Goldmann tonometer during visits | Days 0 (Basal Visit) 3 (Visit 1), 8 (Final Visit) |
| Incidence of Stinging | The subjects will be questioned regarding this symptom's incidence (right eye), frecuency, duration and severity will not be considered, only its incidence will. | Days 0 (Basal Visit, 3 (Visit 1) and 8 (Final Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Expected Related Adverse Events | Incidence of expexted related adverse events according to those previously described in bibliography: itching, blurry vision, eyelid pain, conjunctival hyperemia, ocular hypertension. | Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call) |
| Changes in Best Corrected Visual Acuity (BCVA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigacion e Innovacion en Medicina Traslacional | Mexico City | Mexico |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase I, controlled, comparative, parallel groups, double blind, one center.
Not provided
Not provided
Double blind.
| Placebo |
| Other |
Vehicle Control, ophthalmic solution |
|
BCVA will be evaluated through Snellen chart |
| Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit) |
| Changes in the integrity of the ocular surface (fluorescein staining) | Changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E. | Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit) |
| Incidence of ocular symptoms (foreign body sensation and tearing) | The subjects will be questioned regarding this symptoms' incidence. | Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) |