Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®

Launched by LABORATORIOS SOPHIA S.A DE C.V. · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new eye drop solution called PRO-240 to see how safe it is and how well it works compared to a commonly used product called Optive®. The trial focuses on people with dry eye disease, which can cause discomfort and blurry vision. Researchers will look at any unexpected side effects, changes in vision, and whether participants experience any stinging after using the drops.

To join this study, participants need to be at least 18 years old and generally healthy with a good level of vision. They must be willing to attend scheduled visits and follow the study guidelines. However, individuals with certain health conditions, recent eye surgery, or those using specific medications may not be eligible. Participants will be monitored closely throughout the trial to ensure their safety and to gather important information about the new eye drops.

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 ≥18 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 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.