Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.

Launched by LABORATORIOS SOPHIA S.A DE C.V. · Apr 17, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate the safety and tolerability of a new eye drop solution called PRO-190, comparing it to a well-known product called Systane Ultra®. The study focuses on individuals who suffer from dry eyes, looking to understand how well the new solution works and if it causes any unexpected side effects. The researchers will monitor changes in vision, eye comfort, and overall eye health during the trial.

To participate, you need to be at least 18 years old, in good health, and able to attend scheduled visits. You should not have worn contact lenses or have certain health conditions, such as diabetes or a history of eye diseases. Throughout the study, you'll use the eye drops as instructed and report any side effects. This is an important step to help determine if PRO-190 could be a safe and effective option for people with dry eyes in the future.

Gender

ALL

Eligibility criteria

• 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.