Status:
COMPLETED
Clinical Trial to Compare the Safety and Efficacy of Nanodrop®
Lead Sponsor:
Laboratorios Sophia S.A de C.V.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2021
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04111965
Start Date
December 1 2020
End Date
December 10 2021
Last Update
July 16 2025
Active Locations (6)
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1
Catarata y Glaucoma de Occidente
Guadalajara, Jalisco, Mexico, 44160
2
Clínica de Investigación en Reumatología y Obesidad S.C.
Guadalajara, Jalisco, Mexico, 44650
3
Jose Navarro Partida
Guadalajara, Jalisco, Mexico, 45160
4
Health Pharma Professional Research S.A. de C.V.
Mexico City, Mexico City, Mexico, 03100