Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagr… (NCT04702776) | Clinical Trial Compass
CompletedPhase 4
Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye.
Mexico182 participantsStarted 2021-12-09
Plain-language summary
Phase IV, non inferiority, controlled, open, multicenter clinical study to compare the efficacy of the Ophthalmic Solution Humylub Ofteno® PF against Hyabak® and Lagricel Ofteno® PF applied quater in die (QID) for 30 days in patients with mild to moderate dry eye disease.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Being capable of voluntarily grant a signed informed consent.
* Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
* Age ≥ 18 years old
* Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.
* Presenting a mild to moderate dry eye disease diagnosis, defined as:
* OSDI score ≥ 13, plus one of the following:
* More than 5 dots of corneal staining
* More than 9 dots of conjunctival staining
* Tear break-up time \< 10 seconds
Exclusion Criteria:
* \- Pregnancy, breastfeeding or planning to become pregnant during the time of the study
* Having participated in clinical trials within 30 days prior to the eligibility visit.
* Having participated previously in this study.
* BCVA equal or worse than 20/200, in either eye.
* Diagnosis of any of the following:
* Allergic, viral or bacterial conjunctivitis
* Anterior blepharitis
* Parasite infestation of any ocular or annex structures (Demodex, for example)
* Unresolved history of ocular trauma
* Scarring diseases of the ocular surface
* Corneal or conjunctival ulcers
* Filamentary keratitis
* Neurotrophic keratitis
* Bullous keratopathy
* Neoplastic diseases of the ocular surface or ocular annexes
* Diseases presenting fibrovascular proliferations on t…