Dry EyePhase 1/2PRO-176/INCT04111965
Clinical Trial to Compare the Safety and Efficacy of Nanodrop®
A Phase 1/2 study testing Nanodrop® and Systane Balance in people with Dry Eye, run by Laboratorios Sophia S.A de C.V. at 6 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Nanodrop® and Systane Balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 6 sitesMexico
- Study dates
- 1 Dec 2020to 10 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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:
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Mexico6 sites
Catarata y Glaucoma de Occidente
Guadalajara, Jalisco, 44160
Clínica de Investigación en Reumatología y Obesidad S.C.
Guadalajara, Jalisco, 44650
Jose Navarro Partida
Guadalajara, Jalisco, 45160
Health Pharma Professional Research S.A. de C.V.
Mexico City, Mexico City, 03100
Asociación para Evitar la Ceguera en México, I.A.P.
Mexico City, Mexico City, 04030
Centro Potosino de Investigación Médica SC
San Luis Potosí City, 78250
About this study
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 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
Read more
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
- Being tested
- Nanodrop®, Systane Balance
- Keywords
- Dry eye, propylene glycol
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanodrop®Drug
Also called PRO-176, Propylene glycol 0.6%
minimum to meet 1 drop 4 times a day, both eyes
Systane BalanceDrug
Also called Propylene glycol 0.6%
minimum to meet 1 drop 4 times a day, both eyes
| Study group | Role | What they receive |
|---|---|---|
| Nanodrop® (PRO-176) | Experimental | - Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic. Receives: Drug: Nanodrop® |
| Systane® Balance | Active comparator | * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc.
* Route of administration: Ophthalmic. Receives: Drug: Systane Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: during the 29 days of evaluation, including the safety call
Secondary outcomes (5)
Visual Acuity (VA)
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.
Measured: will be evaluated at the end of the treatment (day 29, final visit)
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. A greater score is a worse outcome.
Measured: will be evaluated at the end of the treatment (day 29, final visit)
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. A higher score is a worse outcome.
Measured: will be evaluated at the end of the treatment (day 29, final visit)
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
Measured: will be evaluated at the end of the treatment (day 29, final visit)
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.
Measured: will be evaluated at the end of the treatment (day 29, final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Dec 2020
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo Baiza Durán, MD, Study director, Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111965
- Sponsor's protocol ID
- SOPH176-1218/I-II
- Acronym
- PRO-176/I
- Status last verified
- Jun 2025
- First submitted
- 30 Sep 2019
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37077305
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04111965
- Acronym / sponsor ID
- PRO-176/I / SOPH176-1218/I-II
- Conditions
- Dry Eye
- Keywords
- Dry eye, propylene glycol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Nanodrop® (PRO-176) | Experimental | Drug: Nanodrop®- Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic. |
| Systane® Balance | Active comparator | Drug: Systane Balance* Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanodrop®Also: PRO-176, Propylene glycol 0.6%minimum to meet 1 drop 4 times a day, both eyes | Drug | Nanodrop® (PRO-176) |
| Systane BalanceAlso: Propylene glycol 0.6%minimum to meet 1 drop 4 times a day, both eyes | Drug | Systane® Balance |
Primary outcome
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.
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
5 secondary outcomes
Visual Acuity (VA)
Time frame: will be evaluated at the end of the treatment (day 29, final visit)
Epithelial Defects (ED) Fluorescein Stain
Time frame: will be evaluated at the end of the treatment (day 29, final visit)
Epithelial Defects (ED) Green Lissamine
Time frame: will be evaluated at the end of the treatment (day 29, final visit)
Incidence of Expected Adverse Events
Time frame: will be evaluated at the end of the treatment (day 29, final visit)
Tear Breakup Time (TBUT)
Time frame: will be evaluated at the end of the treatment (day 29, final visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37077305Baiza-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leopoldo Baiza Durán, MD study director
Laboratorios Sophia S.A de C.V.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nanodrop® and Systane Balance in people with Dry Eye, run by Laboratorios Sophia S.A de C.V. at 6 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) (time frame: will be evaluated at the end of the treatment (day 29, final visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.