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Clinical Trial to Compare the Safety and Efficacy of Nanodrop® (PRO-176/I)

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

Nanodrop®

Systane Balance

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, propylene glycol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Health Pharma Professional Research S.A. de C.V.
Asociación para Evitar la Ceguera en México, I.A.P.
Catarata y Glaucoma de Occidente
Clínica de Investigación en Reumatología y Obesidad S.C.
Jose Navarro Partida
Centro Potosino de Investigación Médica SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nanodrop® (PRO-176)

Systane® Balance

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 (ratings: 0-100). Similar to the index for ocular surface diseases, the ocular comfort index (OCI) evaluates symptoms. It contains items that focus on the discomfort associated with alterations of the ocular surface. Each of these questions has two parts, which concern separately the frequency and severity of symptoms.

Incidence of unexpected events 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

Secondary Outcome Measures

visual acuity (VA)

Visual acuity (VA) is a test of visual function. It will be evaluated at baseline, without refractive correction with the Snellen chart.Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3meters from the subject to be evaluated. The snellen chart consists of a booklet with 11 lines composed of letters, each line has a different size and a different weighting. the subject is placed at a safe distance and 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.

Epithelial Defects (ED) Fluorescein stain

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

epithelial Defects (ED) Green lissamine

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

Incidence of expected adverse events

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

Tear breakup time (TBUT)

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.

Full Information

NCT ID

NCT04111965

First Posted

September 30, 2019

Last Updated

December 26, 2022

Sponsor

Laboratorios Sophia S.A de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT04111965

Brief Title

Clinical Trial to Compare the Safety and Efficacy of Nanodrop®

Acronym

PRO-176/I

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

December 10, 2021 (Actual)

Study Completion Date

December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry eye, propylene glycol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nanodrop® (PRO-176)

Arm Type

Experimental

Arm Description

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

Arm Title

Systane® Balance

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nanodrop®

Other Intervention Name(s)

PRO-176, Propylene glycol 0.6%

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Systane Balance

Other Intervention Name(s)

Propylene glycol 0.6%

Intervention Description

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

Primary Outcome Measure Information:

Title

Ocular Surface Disease Index (OSDI)

Description

Time Frame

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

Title

Incidence of unexpected events related to the research product

Description

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

Time Frame

during the 29 days of evaluation, including the safety call

Secondary Outcome Measure Information:

Title

visual acuity (VA)

Description

Time Frame

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

Title

Epithelial Defects (ED) Fluorescein stain

Description

Time Frame

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

Title

epithelial Defects (ED) Green lissamine

Description

Time Frame

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

Title

Incidence of expected adverse events

Description

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

Time Frame

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

Title

Tear breakup time (TBUT)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leopoldo Baiza Durán, MD

Organizational Affiliation

Laboratorios Sophia S.A de C.V.

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Ciudad de mexico

State/Province

Ciudad De México

ZIP/Postal Code

03100

Country

Mexico

Facility Name

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

City

Ciudad de mexico

State/Province

Ciudad De México

ZIP/Postal Code

04030

Country

Mexico

Facility Name

Catarata y Glaucoma de Occidente

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Clínica de Investigación en Reumatología y Obesidad S.C.

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Jose Navarro Partida

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

45160

Country

Mexico

Facility Name

Centro Potosino de Investigación Médica SC

City

San Luis Potosí

ZIP/Postal Code

78250

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Trial to Compare the Safety and Efficacy of Nanodrop®

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