Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes
Conditions
Brief summary
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®.
Detailed description
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
Interventions
DRUGPRO-190
Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution.
DRUGSystane Ultra®
Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution.
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Single-blind
Intervention model description
Phase I, controlled, comparative, controlled, comparative.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Having the ability to voluntarily give their signed informed consent. * Clinically healthy subjects. * Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures. * Age ≥ 18 years. * No history of contact lens wear * Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO \[Tubal Ligation\]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the ied consent form \[ICF\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period. * Having vital signs within normal parameters. * Best corrected visual acuity (BCVA) of 20/30 or better in both eyes. * Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.
Exclusion criteria
* History of hypersensitivity to any of the components of the drugs under investigation. * Use of ophthalmic medications from any pharmacological group. * Use of medications by any other route of administration. * In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period. * Having participated in any clinical research study 30 days prior to inclusion in this study. * Having previously participated in this same study. * History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension. * Diagnosis of glaucoma or ocular hypertension. * Known diagnosis of liver or heart disease. * Presenting active inflammatory or infectious disease at the time of entry into the study. * Presenting unresolved lesions or traumas at the time of entry into the study. * Having been subjected to non-ophthalmological surgical procedures in the last 3 months. * Being or having an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an employee of the research site or the sponsor, and who directly participates in this study. Elimination Criteria * Withdrawal of their consent to participate in the study (informed consent form). * Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures. * Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine). * Non-tolerability or hypersensitivity to any of the drugs under investigation. * Adherence \< 80% determined by the subject's diary and corroborated by the final weight of the research products (RP) compared to the initial weight.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Unexpected Related Adverse Reactions | 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. | Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Best Corrected Visual Acuity (BCVA) | 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. | The BCVA will be evaluated through Snellen chart. |
| Changes in 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. | 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. |
| Changes in the ocular comfort index (OCI) score in between interventions | 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 Ocular Comfort Index (OCI) score in between interventions, the subjects will be questioned regarding this symptoms' incidence. |
| Changes in the integrity of the ocular surface (fluorescein staining) | 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 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. |
| Changes in lissamine green staining | 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. | Direct observation with slit lamp, graded according to (changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance \[SICCA\].) |
| Changes in intraocular pressure (IOP) | 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. | Previous instillation of topical anesthetic, the IOP will be measured through a Goldmann tonometer during visits. |
Contacts
Primary ContactAlejandra Sanchez-Rios, MD
Outcome results
None listed