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

NCT06375343 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SOPH240-0923/I
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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®.

Conditions

Dry Eye Disease; Dry Eye Sensation; Ocular Surface Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of unexpected adverse events related to the interventions

  Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.

  Days 0: (Basal Visit), 8 (Final Visit) and 11 (Safety Call)

Secondary Outcomes (7)

• Changes in the Ocular Comfort Index score

  Days: 0 (Basal Visit), and 8 (Final Visit)

• Adherence to treatment (adherence) Adherence to treatment (adherence)

  Days: 8 (Final Visit)

• Changes in Best Corrected Visual Acuity (BCVA)

  Days: 0 (Basal Visit) and 8 (Final Visit)

• Changes in tear film breakup time

  Days: 0 (Basal Visit) and 8 (Final Visit)

• Changes in intraocular pressure (IOP)

  Days: 0 (Basal Visit) and 8 (Final Visit)

Study Arms (2)

PRO-240

EXPERIMENTAL

* Propylene glycol 0.3% - Polyethylene glycol 400 0.5% - Glycerin 0.2%. Ophthalmic solution. * Dosage: 1 drop QID \[4\] (four times per day) for 7 days in both eyes. * Route of administration: Ophthalmic

Drug: PRO-240

Optive®

ACTIVE COMPARATOR

* Carboxymethylcellulose 0.5%; Glycerin 0.9%. Ophthalmic solution. * Dosage: 1 drop QID \[4\] (four times per day) for 7 days in both eyes. * Route of administration: Ophthalmic

Drug: Optive®

Interventions

PRO-240 DRUG

-Propylene glycol 0.3%, Polyethylene glycol 400 0.5%, and Glycerin 0.2%. Ophthalmic solution.

PRO-240

Optive® DRUG

\- Carboxymethylcellulose 0.5%, and Glycerin 0.9%. Ophthalmic solution.

Optive®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Alejandra Sanchez-Rios, MD

CONTACT

33 3001 4200; alejandra.sanchez@sophia.com.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I, controlled, comparative, single-blind, single-center, comparative clinical trial.

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 19, 2024
• Study Start: January 30, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share