Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV) (087LATAMFIV)
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|ClinicalTrials.gov Identifier: NCT03223909|
Recruitment Status : Completed
First Posted : July 21, 2017
Results First Posted : October 31, 2019
Last Update Posted : October 31, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|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.|
|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|
Experimental: PRO-087 PF
Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.
0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate
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%
- Visual Acuity [ Time Frame: Change from Baseline visual acuity at 90 days ]Best-corrected visual acuity
- 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.
- 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
- 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.
- Adverse Events [ Time Frame: 90 days ]Presence of adverse events modifying some of the abovementioned criteria or others, evaluated as serious.
- 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.
- Goblet Cells Population [ Time Frame: Change from Baseline Goblet cells population at 90 days ]Increase of 20% from baseline
- 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.
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
|Fernando Rodriguez Sixtos Higuera|
|Irapuato, Guanajuato, Mexico, 36670|
|Study Director:||Leopoldo Baiza, MD||Laboratorios Sophia S.A de C.V.|