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This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.
The variables to be evaluated include:
Primary (safety):
Incidence Unexpected Related Adverse Reactions
Secondary:
Changes in the ocular comfort index (OCI) score in between interventions Changes in Best Corrected Visual Acuity (BCVA) Changes in tear film breakup time Changes in intraocular pressure (IOP) Changes in the integrity of the ocular surface (fluorescein staining) Changes in lissamine green staining
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-190 | Experimental | Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution. Dosage: 1 drop QID [4] (4 times per day, at least three hours apart between doses) for 7 days in both eyes, Route of administration: Ophthalmic. |
|
| Systane Ultra® | Active Comparator | Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution. Dosage: 1 drop QID [4] (4 times per day, at least three hours apart between doses) for 7 days in both eyes, Route of administration: Ophthalmic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-190 | Drug | Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution. |
| |
| 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. | Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the ocular comfort index (OCI) score in between interventions | Changes in the Ocular Comfort Index (OCI) score in between interventions, the subjects will be questioned regarding this symptoms' incidence. | Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject. |
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Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez-Rios, MD | Contact | 33 3001 4200 | alejandra.sanchez@sophia.com.mx |
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Phase I, controlled, comparative, controlled, comparative.
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Single-blind
| Systane Ultra® |
| Drug |
Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution. |
|
| Changes in Best Corrected Visual Acuity (BCVA) | The BCVA will be evaluated through Snellen chart. | Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject. |
| Changes in tear film breakup time | The most common method for assessing stability is with fluorescein. The precorneal layer colored with fluorescein will change to less fluorescent or non-fluorescent regions. The time from the last blink to the appearance of these regions is the tear film breakup time. | Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject. |
| Changes in intraocular pressure (IOP) | Previous instillation of topical anesthetic, the IOP will be measured through a Goldmann tonometer during visits. | Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject. |
| 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. | Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject. |
| Changes in lissamine green staining | Direct observation with slit lamp, graded according to (changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance [SICCA].) | Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject. |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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