Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV)
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Syndrome
Intervention: PRO-087; Systane Ultra; Systane Ultra Preservative Free
Intervention description: 0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate; Is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative.; Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled, double-blind, randomized, clinical trial comparing the safety and efficacy parameters between a group of subjects with a diagnose of mild to moderate tear film dysfunction syndrome under a regimen of ophthalmic solution lubricant drops PRO-087 versus subject under Systane® Ultra or Systane® Ultra preservative free, with the same diagnosis, with a follow-up of 90 days.
Masking: Double (Participant, Investigator)
Masking description: The double-blind study is a procedure in which the patient and the treating doctor ignore to which intervention group the study patient was assigned. To achieve the blinding of both the drug in research and both comparator drugs, these will be labeled in the same way (masking). Besides the figure of an unblinded pharmacist, who is responsible for the delivery of the medication to the patient, will be added. Blinding codes are protected by an outsider appointed by the study sponsor. The codes are also available in the research center (fully sealed), so that they can be consulted by the investigator in case a subject presents a serious adverse event, prior authorization from the study sponsor; the blinding also continues rigorous during the data analysis and interpretation.
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: dry eye; Chondroitin sulfate; Ocular lubricants

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 to < 90 years old

          -  Both sexes

          -  Mild to moderate tear film dysfunction clinical diagnose

          -  Mild to moderate clinical stage of the disease

               -  TBUT > 5 sec. and < 10 sec.

               -  Schirmer: > 4 mm and < 14 mm

               -  OSDI < 30 points

               -  Corneal staining < grade III on the Oxford scale

          -  Availability to go to each revision when indicated.

        Exclusion Criteria:

        General Criteria

          1. Subjects with topical and/or systemic medication or mechanical devices that interfere
             determinedly on the results of the study (such as topical immunomodulators, punctal
             plugs, corticosteroids, preservative artificial tears, contact lenses).

          2. Subjects (females) with active sexual life that do not use a contraceptive method.

          3. Female subjects who are pregnant or lactating

          4. Female subjects with a positive urine pregnancy test

          5. Positive drug addictions* (verbal interrogatory)

          6. Subjects who have participated on any other research clinical trials on the last 40
             days

          7. Subjects legal or mentally disabled to give an informed consent for participating on
             this study

          8. Subjects who can't comply with the appointments or with every protocol requirement.

        Criteria related with ophthalmic ailments

          1. Serious tear film dysfunction syndrome TBUT < 5 s Schirmer: < 4 mm OSDI > 30 pints
             Corneal staining > grade III on the Oxford scale

          2. Non perforated corneal ulcer

          3. Perforated corneal ulcer

          4. Autoimmune corneal ulcer

          5. Ocular surface scarring diseases

          6. Ocular surface or annexes metaplastic lesions

          7. Fibro vascular proliferation lesions on the conjunctival and/or corneal surface (i.e.:
             pterygium)

          8. Concomitant chronic inflammatory diseases on any ocular structure

          9. Acute or infectious inflammatory disease

         10. Corneal disease potentially requiring a treatment during the following 3 months

         11. Use of topical or systemic drug products classified as forbidden

         12. Ocular surgical procedures 3 months before the protocol inclusion

         13. Treatments or procedures indicated on the tear film dysfunction treatment, as punctal
             silicone plugs.

         14. Posterior segment diseases requiring a treatment or threatening the visual prognosis

         15. Retinal diseases potentially requiring treatment during the following 3 months

         16. History of penetrating keratoplasty.

         17. Soft or hard contact lenses use during the last month from inclusion day