Clinical Trial to Compare the Safety and Efficacy of Nanodrop®

NCT04111965 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH176-1218/I-II
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 6

Brief Summary

Study design: Phase I-II clinical trial, comparative, non-inferiority with active control, parallel groups, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects of the Nanodrop® group, if there are less than 20% of unexpected Events (EA), related to the research product, recruitment is continued until the sample is completed for efficacy analysis objectives Security: Evaluate the safety of the ophthalmic application of Nanodrop® by quantifying the incidence of unexpected Adverse Events (EA) related to the research product (PI). Effectiveness: Demonstrate the non-inferiority of Nanodrop® compared to Systane® Balance, in the efficacy of the treatment of patients with dry eye, by means of the Ocular Surface Disease Index (OSDI). Hypothesis Security: H0 = Nanodrop® is safe in its ophthalmic application as it presents an incidence of unexpected adverse events related to the research drug, less than 20% of the population of Nanodrop® safety group. H1 = Nanodrop® is not safe in its ophthalmic application, as it presents an incidence of unexpected adverse events related to the research drug, exceeding 20% of the population of Nanodrop® safety group. Effectiveness: H0 = Nanodrop® is lower than Systane® Balance by more than 5 points in the OSDI test score. H1 = Nanodrop® is lower than Systane® Balance by 5 points or less in the OSDI test score. Number of subjects: n = 126 evaluable subjects 63 evaluable subjects per group (both eyes). Main inclusion criteria: Dry eye diagnosis Duration of intervention treatment: 28 days Approximate duration of the subject in the study: 35 days

Conditions

Dry Eye

Keywords

Dry eye; propylene glycol

Outcome Measures

Primary Outcomes (2)

• Ocular Surface Disease Index (OSDI)

  OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale.. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.

  will be evaluated at the end of the treatment (day 29, final visit)

• Percentage of Unexpected Adverse Events (AE) Related to the Research Product

  the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent

  during the 29 days of evaluation, including the safety call

Secondary Outcomes (5)

• Visual Acuity (VA)

  will be evaluated at the end of the treatment (day 29, final visit)

• Epithelial Defects (ED) Fluorescein Stain

  will be evaluated at the end of the treatment (day 29, final visit)

• Epithelial Defects (ED) Green Lissamine

  will be evaluated at the end of the treatment (day 29, final visit)

• Incidence of Expected Adverse Events

  will be evaluated at the end of the treatment (day 29, final visit)

• Tear Breakup Time (TBUT)

  will be evaluated at the end of the treatment (day 29, final visit)

Study Arms (2)

Nanodrop® (PRO-176)

EXPERIMENTAL

\- Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic.

Drug: Nanodrop®

Systane® Balance

ACTIVE COMPARATOR

* Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic.

Drug: Systane Balance

Interventions

Nanodrop® DRUG

minimum to meet 1 drop 4 times a day, both eyes

Also known as: PRO-176, Propylene glycol 0.6%

Nanodrop® (PRO-176)

Systane Balance DRUG

minimum to meet 1 drop 4 times a day, both eyes

Also known as: Propylene glycol 0.6%

Systane® Balance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have the ability to voluntarily grant your signed informed consent
• Power and willingness to comply with scheduled visits treatment plan and other study procedures
• Be willing to modify the activities of your lifestyle.
• Be of legal age
• Women of reproductive age should ensure continuation (initiated ≥ 30 days prior to the signing of the Informed Consent Form or ICF) of using a hormonal contraceptive method or intrauterine device (IUD) during the study period
• Present a dry eye diagnosis, defined by:
• OSDI ≥ 13 points plus one of the following:
• Corneal staining with more than 5 sites
• Conjunctival staining with more than 9 sites
• Breakup Time of lacrimal film (BUT) \<10 seconds:

You may not qualify if:

• In the case of women: being pregnant, breastfeeding or planning to get pregnant within the study period.
• Have participated in another clinical research study ≤ 30 days before the scrutiny visit.
• Having previously participated in this study.
• Present a Better Corrected Visual Acuity (MAVC) of 20/200 or worse in one of the eyes.
• Present an added ophthalmological diagnosis of:
• Allergic, viral or bacterial conjunctivitis. Anterior blepharitis. Demodex. Eye parasitic infections. Unresolved eye trauma. Healing diseases of the ocular surface. Corneal or conjunctival ulcers. Filamentous keratitis. Neurotrophic keratitis. Bullous keratopathy. Neoplastic diseases on the ocular surface or annexes. Diseases with fibrovascular proliferations on the conjunctival and / or corneal surface.
• Diseases in the retina and / or posterior segment that require treatment or threaten the visual prognosis.
• Glaucoma
• Have a management of your dry eye that requires the implementation of stage 2 treatments of the recommendations in the treatment and management by stages for the dry eye disease from the Dry Eye Workshop II of The Tear Film and Ocular Surface Society (DEWS II, TFOS).
• Have a history of drug addiction or current drug dependence or within the last two years prior to the signing of the Informed Consent Form.
• Have a history of ocular surgical procedure within the last 3 months prior to the signing of the Informed Consent Form.
• Having another medical condition, acute or chronic, that at the discretion of the researcher could increase the risk associated with participation in the study or administration of the product under investigation, or that could interfere with the interpretation of the results of the study.
• Present known hypersensitivity to the components of the products under investigation.
• Be or have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is an employee of the research site or the sponsor, and who participates directly in this study.

Sponsors & Collaborators

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

Study Sites (6)

Catarata y Glaucoma de Occidente

Guadalajara, Jalisco, 44160, Mexico

Location

Clínica de Investigación en Reumatología y Obesidad S.C.

Guadalajara, Jalisco, 44650, Mexico

Location

Jose Navarro Partida

Guadalajara, Jalisco, 45160, Mexico

Location

Health Pharma Professional Research S.A. de C.V.

Mexico City, Mexico City, 03100, Mexico

Location

Asociación para Evitar la Ceguera en México, I.A.P.

Mexico City, Mexico City, 04030, Mexico

Location

Centro Potosino de Investigación Médica SC

San Luis Potosí City, 78250, Mexico

Location

Related Publications (1)

• Baiza-Duran LM, Munoz-Villegas P, Sanchez-Rios A, Olvera-Montano O. Efficacy and Safety of an Ophthalmic DMPC-Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial. J Ophthalmol. 2023 Apr 10;2023:1431473. doi: 10.1155/2023/1431473. eCollection 2023.

  PMID: 37077305 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Propylene Glycol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Alejandra Sanchez-Ríos M.D.
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

:+52 (33) 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking will be done through the primary and secondary packaging. They will be identified by means of identical tags. Which, in compliance with current and applicable regulations, must contain at least: * Name, address and telephone number of the sponsor. * Pharmaceutical form and route of administration. * Lot Number. * Legend "Exclusively for clinical studies" * Date of Expiry.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I-II clinical trial, comparative, non-inferiority with active control, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: December 1, 2020
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (6)