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This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects.
The variables to be evaluated include:
Primary objective:
- To evaluate the safety and tolerability of PRO-229 ophthalmic solution compared to Lagricel® Ofteno PF in clinically healthy subjects.
Specific objective:
- To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF through the incidence of adverse events related to both investigational products.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-229 | Experimental |
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| Lagricel® Ofteno PF | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-229 | Drug | - Dexpanthenol 2% and sodium hyaluronate 0.15% 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), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Best Corrected Visual Acuity (BCVA) | BCVA will be evaluated through Snellen chart | Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject. |
| Changes in ocular surface staining using SICCA ocular staining score scale |
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Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociacion Mexicana para la Investigacion Clinica | Pachuca | Hidalgo | 42070 | Mexico |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C492821 | CD5L protein, human |
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Phase I, controlled, comparative, double-masked, single-center, randomized, controlled clinical trial.
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| Lagricel® Ofteno PF |
| Drug |
- Sodium hyaluronate 0.4%. Ophthalmic solution. |
|
Changes in ocular surface staining will be evaluated using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects. |
| Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject. |
| Incidence of chemosis | Incidence of chemosis will be evaluated through direct observation by principal investigator 0 = Absent 1 = Present | Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject. |
| Incidence of grade 3 or 4 conjunctival hyperemia. | Conjunctival hyperemia will be evaluated through Efron grading scale. | Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject. |
| Adherence to treatment (adherence) | Adherence will be evaluated through the treatment record in the subject's diary. | Through an average of 8 days. This evaluations will take place on days 8 (Final Visit) after the inclusion of each subject. |