Skip to main content
. 2015 Jun 1;2015(6):CD009566. doi: 10.1002/14651858.CD009566.pub2

Höffling‐Lima 2001.

Methods Parallel‐group RCT
Participants 40 participants with allergic conjunctivitis
Interventions Two treatment arms: ketotifen 0.05%; olopatadine 0.1%. Duration of treatment 30 days
Outcomes Participants' assessment of severity of ocular symptoms: itching, burning, watering, discharge, photophobia (4‐point scale; 0 = none, 3 = severe)
Investigator assessment of ocular signs
Time points: at days 1, 2, 7, 14, and 30 after treatment
Country Brazil
Number randomised, gender (male:female) 40 participants randomised, 34 participants analysed. M:F 15:19
Age mean (SD), median, range Mean (range) 27 years (5‐73)
Notes Study conducted from 1 February to 30 June 1999. Source of funding not stated. The authors declared no commercial interest in the drugs evaluated and did not receive any direct or indirect benefit or financial support for this study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation (p.416 ‐ methods): "A masked and randomised clinical study was conducted..."
"the introduction of treatment was randomized beforehand..."
Allocation concealment (selection bias) Unclear risk The method used to conceal the allocation sequence was not described
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Data were nearly fully reported, with 15% lost to follow‐up, and reasons were given
Selective reporting (reporting bias) Low risk Evidence was available of proper outcome reporting
Other bias Low risk No apparent evidence of other risk of bias
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Masking of participants (p.416 ‐ methods): "A masked and randomised clinical study was conducted..."
"... and bottles with topical medications were masked by ophthalmos laboratory."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Masking of investigator (p.417 ‐ methods): "only the medical monitors delivered the drugs to patients..."