Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV) (087LATAMFIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03223909
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : April 27, 2018
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

Brief 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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: PRO-087 Drug: Systane Ultra Drug: Systane Ultra Preservative Free Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
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.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Systane ® Ultra Preservative Free on Tear Film Dysfunction Syndrome From Mild to Moderate
Actual Study Start Date : October 13, 2016
Estimated Primary Completion Date : July 16, 2018
Estimated Study Completion Date : September 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Systane

Arm Intervention/treatment
Experimental: PRO-087 PF
Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.
Drug: PRO-087
0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate
Other Names:
  • Chondroitin sulfate
  • sodium hyaluronate

Active Comparator: Systane Ultra

Systane Ultra ophthalmic solution, Dropper bottle, Multidose.

1 drop every 4 hours for 90 days.

Drug: Systane Ultra
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.
Other Name: polyethylene glycol 400, propylene glycol

Active Comparator: Systane Ultra PF

Systane Ultra, preservative free ophthalmic solution, single-use vials.

1 drop every 4 hours for 90 days.

Drug: Systane Ultra Preservative Free
Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,
Other Name: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%

Primary Outcome Measures :
  1. visual acuity [ Time Frame: Change from Baseline visual acuity at 90 days ]
    Best-corrected visual acuity

Secondary Outcome Measures :
  1. Corneal epithelization [ Time Frame: Change from Baseline Corneal epithelization at 90 days ]
    Percentage of the damaged epithelium of the ocular surface, reduction of staining according to the oxford scale.

  2. Tear film break-up time [ Time Frame: Change from Baseline Tear film break-up time at 90 days ]
    Increase in the residence of the teal film, measured in seconds. Increase of 30% from baseline or equal or more than 10 sec.

  3. Schirmer test [ Time Frame: Change from Baseline Schirmer test at 90 days ]
    Increase of more than 30%

  4. Adverse events [ Time Frame: 90 days ]
    Presence of adverse events modifying some of the abovementioned criteria or others, evaluated as serious.

  5. Ocular Surface Disease Index (OSDI) [ Time Frame: Change from Baseline OSDI at 90 days ]
    Reduction of 20% of the total score from the baseline score.

  6. Goblet cells population [ Time Frame: Change from Baseline Goblet cells population at 90 days ]
    Increase of 20% from baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03223909

Contact: Ricardo Llamas, PhD +52 (33) 3001 4200 ext 1259
Contact: Oscar Olvera, MD +52 (33) 3001 4200 ext 1074

Fernando Rodriguez Sixtos Higuera Recruiting
Irapuato, Guanajuato, Mexico, 36670
Contact: Karla mendez, MD    462 6243572   
Contact: Saul perez, MD    462 6243572   
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Study Director: Leopoldo Baiza, MD Laboratorios Sophia S.A de C.V.

Responsible Party: Laboratorios Sophia S.A de C.V. Identifier: NCT03223909     History of Changes
Other Study ID Numbers: SOPH087-0415/IV
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: For security and laws implemented by the regulatory entity can not share personal data of research subjects.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laboratorios Sophia S.A de C.V.:
dry eye
Chondroitin sulfate
Ocular lubricants

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Pathologic Processes
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents