Phase 4
Completed N=326
Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV)
Source: ClinicalTrials.gov NCT03223909 ↗Enrolled (actual)
326
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Visual Acuity — 0.187; 0.215; 0.219; 0.172 LogMAR — p=0.080
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
0.187; 0.215; 0.219; 0.172; 0.187; 0.176 | 0.080 |
| SECONDARY Corneal Epithelization Defects With Rose of Bengal |
80.6; 73.4; 77.8; 18.1; 25; 19.1 | 0.468 |
| SECONDARY Tear Film Break-up Time (TBUT) |
7.08; 7.10; 7.10; 8.28; 8.46; 8.52 | 0.0001 sig |
| SECONDARY Schirmer Test |
9.48; 9.05; 9.25; 10.19; 12.21; 12.16 | 0.003 sig |
| SECONDARY Adverse Events |
19.2; 21.1; 20.6 | 0.930 |
| SECONDARY Ocular Surface Disease Index (OSDI) |
16.59; 15.74; 16.31; 5.99; 7.47; 6.32 | 0.548 |
| SECONDARY Goblet Cells Population |
341.2; 338.5; 327.4; 447.3; 413.5; 442.6 | 0.170 |
| SECONDARY Corneal Epithelization Defects With Fluorescein |
52.8; 53.1; 53.7; 36.8; 36.7; 10.4 | 0.085 |
Eligibility Criteria
Inclusion Criteria
- >18 to 5 sec. and 4 mm and 30 pints Corneal staining > grade III on the Oxford scale
- Non perforated corneal ulcer
- Perforated corneal ulcer
- Autoimmune corneal ulcer
- Ocular surface scarring diseases
- Ocular surface or annexes metaplastic lesions
- Fibro vascular proliferation lesions on the conjunctival and/or corneal surface (i.e.: pterygium)
- Concomitant chronic inflammatory diseases on any ocular structure
- Acute or infectious inflammatory disease
- Corneal disease potentially requiring a treatment during the following 3 months
- Use of topical or systemic drug products classified as forbidden
- Ocular surgical procedures 3 months before the protocol inclusion
- Treatments or procedures indicated on the tear film dysfunction treatment, as punctal silicone plugs.
- Posterior segment diseases requiring a treatment or threatening the visual prognosis
- Retinal diseases potentially requiring treatment during the following 3 months
- History of penetrating keratoplasty.
- Soft or hard contact lenses use during the last month from inclusion day
Data sourced from ClinicalTrials.gov (NCT03223909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.