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

Dry Eye Clinical Trial

Official title:

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379685
• Other study ID #: SOPH190-0923/I
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 30, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Laboratorios Sophia S.A de C.V.
• Contact: Alejandra Sanchez-Rios, MD
• Phone: 33 3001 4200
• Email: alejandra.sanchez[@]sophia.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Dry Eyes Chronic
• Keratoconjunctivitis Sicca

Intervention

Drug:
• PRO-190
Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution.
• Systane Ultra®
Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Unexpected Related Adverse Reactions	Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.	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.
Secondary	Changes in the ocular comfort index (OCI) score in between interventions	Changes in the Ocular Comfort Index (OCI) score in between interventions, the subjects will be questioned regarding this symptoms' incidence.	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.
Secondary	Changes in Best Corrected Visual Acuity (BCVA)	The BCVA will be evaluated through Snellen chart.	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.
Secondary	Changes in tear film breakup time	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.	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.
Secondary	Changes in intraocular pressure (IOP)	Previous instillation of topical anesthetic, the IOP will be measured through a Goldmann tonometer during visits.	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.
Secondary	Changes in the integrity of the ocular surface (fluorescein staining)	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.	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.
Secondary	Changes in lissamine green staining	Direct observation with slit lamp, graded according to (changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance [SICCA].)	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.