Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo.

Launched by LABORATORIOS SOPHIA S.A DE C.V. · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new eye drop solution called PRO-232 to see how safe it is compared to a placebo (a solution with no active ingredients). The main goal is to check if there are any unexpected side effects and to measure eye pressure after using the drops. This study is in its early phase, meaning it's one of the first steps in testing this treatment. The trial is not yet recruiting participants, but when it does, it will be looking for healthy adults aged 18 to 45 who can commit to attending scheduled visits and following the study guidelines.

To be eligible for this study, participants must be in good eye health, have clear vision, and meet specific health criteria, such as not having certain medical conditions or recent surgeries. Women who can become pregnant must use a reliable contraceptive method during the trial. Those who join can expect regular check-ins, and they’ll be monitored for any side effects after using the eye drops. It's essential for potential participants to know that they cannot currently be using other eye medications or have certain health issues, like glaucoma or recent eye surgery. This trial will help researchers understand if PRO-232 is a safe option for eye care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Having the ability to voluntarily give their signed informed consent.
• • Ophthalmologically and clinically healthy subjects.
• • Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
• • Age between 18 to 45 years.
• • Male or female gender.
• • 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 informed consent form \[ICF\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
• • Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
• • Corneal staining ≤ grade I on the Oxford Scale.
• • Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.
• Exclusion Criteria:
• • History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or 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.
• • Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.
• • History of eye surgery in the last 6 months.
• • Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
• • 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.
• • Active smoking (specified as the consumption of cigarettes regardless of the amount and frequency, 4 weeks prior to study inclusion and during the intervention period of this study).
• • Active alcoholism (specified as the consumption of alcoholic beverages, regardless of the amount and frequency, 72 hours prior to study inclusion and during the intervention period of 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.