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

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7mmp6k
• Date of registration: 24/04/2012
• Primary sponsor: Universidade Federal de São Paulo - São Paulo, SP, Brazil
• Public title: Ocular surface evaluation in ocular hypertension or inicial glaucoma patients treated with drops.
• Scientific title: 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
• Date of first enrolment: 03/03/2011
• Target sample size: 33
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7mmp6k/
• Study design: Therapeutic, parallel, with three arms, single-blinded,prospective, randomized clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Heloisa Giacometti
• Affiliation: Federal University of Sao Paulo

• Name: Heloisa Giacometti
• Affiliation: Federal University of Sao Paulo

Key inclusion & exclusion criteria

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


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

Age minimum: 18
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

H00-H59

Ocular hypertension or Open angle Glaucoma with no previous treatment.
H40.0
H40.1

Intervention(s)

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 +Timolol (LT);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 patients will be underwent routine ophthalmological examination, slit lamp biomicroscopy, Goldmann applanation tonometry and ocular surface evaluation before and after three months of treatment. Ocular surface evaluation will include biomicroscopic examination focusing on the lids, conjunctiva, cornea and tear film. The Schirmer II test will be performed, lissamine green vital staining scores will be recorded and tear film break-up time (TBUT) will be measured before impression cytology samples will be taken. The OSDI questionnaire will be also applied.
Patients were examined by two centers (Graefe Institute of Ophthalmology and Brasilia Base Hospital) following instructions provided by the Cornea and External Disease Department, UNIFESP.

Primary Outcome(s)

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

Secondary Outcome(s)

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).

Secondary ID(s)

0813/08

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo - São Paulo, SP, Brazil

Secondary Sponsor(s)

Universidade Federal de São Paulo - São Paulo, SP, Brazil