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Completed

NCT Number: NCT04111965

Clinical Trial to Compare the Safety and Efficacy of Nanodrop®

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Catarata y Glaucoma de Occidente, Guadalajara, Jalisco, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

Exclusion criteria

  • 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.
  • Be a user of soft or hard contact lenses. You can enter if you can suspend your use during the study, you must turn 15 days without using the contact lens before inclusion.
  • 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.

Treatment and study plan

Nanodrop®

Drug

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

Other names: PRO-176, Propylene glycol 0.6%

Systane Balance

Drug

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

Other names: Propylene glycol 0.6%

Primary outcomes

  1. Ocular Surface Disease Index (OSDI)

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

    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.

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

    Time frame: during the 29 days of evaluation, including the safety call

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

Secondary outcomes

  1. Visual Acuity (VA)

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

    Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.

  2. Epithelial Defects (ED) Fluorescein Stain

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

    The epithelial defects will be evaluated by fluorescein, it is a discrete variable that will be realized by direct observation, It will be qualified according to the Eye Staining Rating (CTO) of the International Alliance of Clinical Collaboration of Sjögren (SICCA).According to the CTO, grade 0 corresponds to the absence of dotted epithelial erosions (EEP); Grade 1 is defined as the presence of 1-5 EEP; Grade 2 corresponds to 6-30 EEP; and> 30 EEP will be classified as grade 3. Additionally a qualification point will be added if: 1) EEP is presented in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches are observed, including linear stains. A greater score is a worse outcome.

  3. Epithelial Defects (ED) Green Lissamine

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

    The epithelial defects will be evaluated by green lissamine, it is a discrete variable that will be realized by direct observation, It will be qualified according to the Eye Staining Rating (CTO) of the International Alliance of Clinical Collaboration of Sjögren (SICCA). In the CTO, grade 0 is defined as the presence of 0 to 9 lissamine green staining points in the interpalpebral bulbar conjunctiva (qualifying the temporal and nasal portion separately); grade 1 is defined by the presence of 10 to 32 points; grade 2 by 33 to 100; and grade 3 for> 100 points. Due to the difficulty of counting individual points in a moving eye, any area ≥ 4mm2 of confluent points is considered> 100 points. A higher score is a worse outcome.

  4. Incidence of Expected Adverse Events

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

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

  5. Tear Breakup Time (TBUT)

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

    brake up time of the tear film One of the first aspects of the tear film that changes when there is an alteration to the ocular surface is its stability. In general, if the corneal or conjunctival surface is damaged, it is unlikely that a stable tear film can be maintained.

    The most common method to evaluate tear film stability is the evaluation of TBUT with fluorescein. Once the fluorescein is instilled, with the cobalt blue filter the patient is asked not to blink after having blinked 1 to 2 times. The colored precorneal fluorescein layer will change to less fluorescent or non-fluorescent regions. The time that elapses from the last blink to the appearance of these regions is the TBUT. It will be reported in seconds.

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

Phase I-II Clinical Trial to Compare the Safety and Efficacy of Nanodrop® Against Systane® Balance in the Treatment of Dry Eye Patients

Acronym: PRO-176/I

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 2, 2019
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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