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

Official title

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-240 Ophthalmic Solution Compared to Optive® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers

Overview

This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.

Detailed description

The variables to be evaluated include:

Primary (safety):

\- Incidence of unexpected advere events (AE's)

Secondary:

* Changes in the ocular comfort index (OCI) score * Changes in intraocular pressure (IOP) * Changes in Best Corrected Visual Acuity (BCVA) * Adherence to treatment * Changes in tear film breakup time * Changes in fluorescein staining * Changes in lissamine green staining

Interventions

• Drug PRO-240
  -Propylene glycol 0.3%, Polyethylene glycol 400 0.5%, and Glycerin 0.2%. Ophthalmic solution.
• Drug Optive®
  \- Carboxymethylcellulose 0.5%, and Glycerin 0.9%. Ophthalmic solution.

Primary outcome measures

• Incidence of unexpected adverse events related to the interventions [Time frame: Days 0: (Basal Visit), 8 (Final Visit) and 11 (Safety Call)]

Secondary outcome measures (7)

• Changes in the Ocular Comfort Index score [Time frame: Days: 0 (Basal Visit), and 8 (Final Visit)]
• Adherence to treatment (adherence) Adherence to treatment (adherence) [Time frame: Days: 8 (Final Visit)]
• Changes in Best Corrected Visual Acuity (BCVA) [Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)]
• Changes in tear film breakup time [Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)]
• Changes in intraocular pressure (IOP) [Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)]
• Changes in the integrity of the ocular surface (fluorescein staining) [Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)]
• Changes in lissamine green staining of the conjunctival surface [Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06375343 · SOPH240-0923/I

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗