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

• Status: Completed
• Trial end date: 2018-12-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Hyaluronic Acid; Ophthalmic Solutions; Pharmaceutical Solutions

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