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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223909
Recruitment Status : Completed
First Posted : July 21, 2017
Results First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 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
Actual Primary Completion Date : October 16, 2018
Actual Study Completion Date : December 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 Defects With Rose of Bengal [ Time Frame: Final Visit (day 90) ]
    Percentage of the damaged epithelium of the ocular surface, reduction of staining according to the oxford scale.

  2. Tear Film Break-up Time (TBUT) [ Time Frame: Base line and Final Visit (day 90) ]
    Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps photos over time. A TBUT under 10 seconds is considered abnormal

  3. Schirmer Test [ Time Frame: Base line and Final Visit (day 90) ]
    Schirmer's test determines whether the eye produces enough tears to keep it moist. This test is used when a person experiences very dry eyes or excessive watering of the eyes. It poses no risk to the subject. A negative (more than 10 mm of moisture on the filter paper in 5 minutes) test result is normal. Both eyes normally secrete the same amount of tears.

  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 ]
    The OSDI, which was created to order to quickly assess the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

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

  7. Corneal Epithelization Defects With Fluorescein [ Time Frame: Final Visit (day 90) ]
    Percentage of the damaged epithelium of the ocular surface, reduction of staining according to the oxford scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT03223909


Locations
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Mexico
Fernando Rodriguez Sixtos Higuera
Irapuato, Guanajuato, Mexico, 36670
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
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Study Director: Leopoldo Baiza, MD Laboratorios Sophia S.A de C.V.
  Study Documents (Full-Text)

Documents provided by Laboratorios Sophia S.A de C.V.:
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Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT03223909    
Other Study ID Numbers: SOPH087-0415/IV
First Posted: July 21, 2017    Key Record Dates
Results First Posted: October 31, 2019
Last Update Posted: October 31, 2019
Last Verified: October 2019
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.

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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:
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Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Eye Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents