Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV)
Status:
Completed
Trial end date:
2018-12-16
Target enrollment:
Participant gender:
Summary
Efficacy and Safety of the Ophthalmic Solution PRO-087 versus Systane ® Ultra and Systane ®
Ultra Preservative Free on the Tear Film Dysfunction Syndrome from Mild to Moderate Clinical
trial To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by
Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological
characteristics of the ocular surface, as well as its distribution and the characteristics of
the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra
Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).
Controlled, randomized, double-blind, masked clinical study, comparing the safety and
efficacy of preservative-free PR0-087 vs Systane Ultra with preservative and Systane Ultra
preservative free, in subjects with mild to moderate tear film dysfunction syndrome, for a
period of 90 days plus 15 days of remote surveillance, in which one of the three agents will
be administered (PR0-087, Systane® Ultra or Systane® Ultra preservative free) with a q.i.d.
dosage. in both eyes, with regular follow-up visits (5 overall).
Best-corrected visual acuity Intraocular pressure Ocular surface Anterior segment examination
Posterior segment examination Tear film break-up time Schirmer test Corneal epithelization
Goblet cells count Adverse events Subjects with a clinical diagnosis of mild to moderate tear
film dysfunction syndrome between 18 and 90 years old, without concomitant eye diseases nor
requiring different treatments of any of the three interventions in this study They will be
randomized in 3 groups where PRO-087, Systane® Ultra o Systane® Ultra preservative free will
be administered.