Randomized, double-blind, parallel group clinical trial to evaluate the efficacy and safety of PRGF eye drops as a treatment for dry eye disease in patients with glaucoma

Conditions

Glaucoma, Dry eye disease

Brief summary

- Change in the degree of ocular staining at 6 months using the Oxford scale. - Evolution of symptomatology at 6 months according to the Ocular Surface Disease Index (OSDI).

Detailed description

- Change in the degree of ocular staining at 3 months using the Oxford scale., Change in symptomatology at 3 months according to the Ocular Surface Disease Index (OSDI)., Change in the amount of tears produced at 3 and 6 months using the Schirmer test., Change in tear breakup time (TBUT) at 3 and 6 months., - Evolution of conjunctival hyperemia at 3 and 6 months using the McMonnies photographic scale., - Evolution of corrected distance visual acuity in both eyes at 3 and 6 months., - Change in the concentration of inflammation biomarkers S100A8 and MMP-9 in tears at 3 and 6 months post-treatment., Demographic and identification variables - Patient code - Age - Sex - Toxic habits (alcohol, tobacco), Safety variables - Global tolerance assessed by the investigator at 3 and 6 months. - Patient-assessed global tolerance at 3 and 6 months. - Type and frequency of ocular adverse events. - Type and frequency of systemic adverse events.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPlasma rich in growth factors

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
- Change in the degree of ocular staining at 6 months using the Oxford scale. - Evolution of symptomatology at 6 months according to the Ocular Surface Disease Index (OSDI).	—

Secondary

Measure	Time frame
- Change in the degree of ocular staining at 3 months using the Oxford scale., Change in symptomatology at 3 months according to the Ocular Surface Disease Index (OSDI)., Change in the amount of tears produced at 3 and 6 months using the Schirmer test., Change in tear breakup time (TBUT) at 3 and 6 months., - Evolution of conjunctival hyperemia at 3 and 6 months using the McMonnies photographic scale., - Evolution of corrected distance visual acuity in both eyes at 3 and 6 months., - Change in the concentration of inflammation biomarkers S100A8 and MMP-9 in tears at 3 and 6 months post-treatment., Demographic and identification variables - Patient code - Age - Sex - Toxic habits (alcohol, tobacco), Safety variables - Global tolerance assessed by the investigator at 3 and 6 months. - Patient-assessed global tolerance at 3 and 6 months. - Type and frequency of ocular adverse events. - Type and frequency of systemic adverse events.	—

Measure

Time frame

- Change in the degree of ocular staining at 3 months using the Oxford scale., Change in symptomatology at 3 months according to the Ocular Surface Disease Index (OSDI)., Change in the amount of tears produced at 3 and 6 months using the Schirmer test., Change in tear breakup time (TBUT) at 3 and 6 months., - Evolution of conjunctival hyperemia at 3 and 6 months using the McMonnies photographic scale., - Evolution of corrected distance visual acuity in both eyes at 3 and 6 months., - Change in the concentration of inflammation biomarkers S100A8 and MMP-9 in tears at 3 and 6 months post-treatment., Demographic and identification variables - Patient code - Age - Sex - Toxic habits (alcohol, tobacco), Safety variables - Global tolerance assessed by the investigator at 3 and 6 months. - Patient-assessed global tolerance at 3 and 6 months. - Type and frequency of ocular adverse events. - Type and frequency of systemic adverse events.

—

Countries

Spain

Outcome results

None listed