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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Design 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

      MAIN OBJECTIVE:

      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.).

      SPECIFIC OBJECTIVES:

      To evaluate the safety of the preservative-free ophthalmic formulation PRO-087 (by
      Laboratorios Sophia, S.A. de C.V.) on the corneal and conjunctival epithelium, intraocular
      pressure, and structures of anterior and posterior segment in patients with tear film
      dysfunction syndrome from mild to moderate.

      To determine the correlation between improvement of clinical status and perceived improvement
      of symptoms of each participant in each study group.

      To compare the qualitative and quantitative histological status of the ocular surface before
      and after the pharmacological intervention in each study group to determine the evolution
      under the intervention of PRO-087.

      To evaluate the quantitative rating of tear film production by the Schirmer Test throughout
      the study.

      To qualitatively assess the tear film production by measuring the tear film break-up time
      stained with fluorescein and cobalt filter.

      Blinding:

      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.

      patients with tear film dysfunction, classified as mild to moderate, will be included and
      randomized into 3 groups; the first being treated with PRO-087 ophthalmic solution, the
      second with Systane® Ultra ophthalmic solution, and the third with ophthalmic solution
      Systane® Ultra preservative free.

      Pharmacological Intervention

      The pharmacological intervention will be the instillation of the ophthalmic solution in the
      bottom of the conjunctival sac during the waking period, in any of the following study
      groups:

        1. Preservative free PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4
           hours for 90 days.

        2. Systane® Ultra ophthalmic solution. Dropper bottle. Multidose. 1 drop every 4 hours for
           90 days.

        3. Systane ® Ultra preservative free ophthalmic solution. Single-use vials. 1 drop every 4
           hours for 90 days.
    

Intervention name(s): PRO-087; Systane Ultra; Systane Ultra Preservative Free
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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,
Other intervention name(s): Chondroitin sulfate; sodium hyaluronate; polyethylene glycol 400, propylene glycol; Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%
Intervention MeSH terms: Hyaluronic Acid
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)
Primary purpose: Treatment
Keywords: dry eye; Chondroitin sulfate; Ocular lubricants