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Ocular surface evaluation in ocular hypertension or inicial glaucoma patients treated with drops.

Ocular surface evaluation in patients treated with prostaglandin analogues or timolol maleate monotherapy compared to patients treated with fixed combination of prostaglandin analogues and timolol maleate 0,5% monotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7mmp6k
Enrollment
Unknown
Registered
2012-04-24
Start date
2011-03-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular hypertension or Open angle Glaucoma with no previous treatment.

Interventions

33 Patients will be allocated in 3 groups includind 11 patients in each, following permuted- block randomization method (Block size=3
allocation rate 1:1:1). These patients will be treated with fixed combination of prostaglandin/timolol maleate monotherapy ( one daily drop) for 3 months, distributed as follows:Group 1- Latanoprost +
Group 2- Bimatoprost + Timolol (BT) and Group 3-Travoprost + Timolol (TT), independently of age, sex or residence. Clinical data collected will include patients’ demographic data (age and sex). All pa
drug
Q45.060
D02.033.100.624.915
D10.251.355.255.550.700

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Glaucoma or ocular hypertension patients with no previous topical hypotensive treatment.

Exclusion criteria

Exclusion criteria: Previous ocular surgery, active ocular inflammation or clinically diagnosed dry eye.

Design outcomes

Secondary

MeasureTime frame
Ocular Surface Changes induced by medications used evaluated by break-up time ( TBUT: normal values over 15 seconds), Schirmmer test (normal above 15mm),Green Lissamine vital stainig ( graduated from zero to 9)and changes of score values of OSDI form between inicial and final evaluation. Celular architecture will be evaluated using impression cytology technique and inflammatory parameters will be detected by immunohistochemistry ( HLA-DR and IL-6).

Primary

MeasureTime frame
IOP Reduction evaluated by ocular tonometry with Goldman Tonometry always at same time (8 am), comparing IOP measurements media pre and post-treatment

Countries

Brazil

Contacts

Public ContactHeloisa Giacometti

Federal University of Sao Paulo

heloisaruss@onda.com.br41-30156222

Outcome results

None listed

Source: REBEC (via WHO ICTRP)