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.|
|ClinicalTrials.gov Identifier: NCT03223909|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
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|
|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|
|Estimated Primary Completion Date :||November 16, 2017|
|Estimated Study Completion Date :||December 16, 2017|
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 [ 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.
- 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.
- Schirmer test [ Time Frame: Change from Baseline Schirmer test at 90 days ]Increase of more than 30%
- 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 ]Reduction of 20% of the total score from the baseline score.
- Goblet cells population [ Time Frame: Change from Baseline Goblet cells population at 90 days ]Increase of 20% from baseline
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
|Contact: Ricardo Llamas, PhD||+52 (33) 3001 4200 ext firstname.lastname@example.org|
|Contact: Oscar Olvera, MD||+52 (33) 3001 4200 ext email@example.com|
|Fernando Rodriguez Sixtos Higuera||Recruiting|
|Irapuato, Guanajuato, Mexico, 36670|
|Contact: Karla mendez, MD 462 6243572 firstname.lastname@example.org|
|Contact: Saul perez, MD 462 6243572 email@example.com|
|Study Director:||Leopoldo Baiza, MD||Laboratorios Sophia S.A de C.V.|