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A pooled data analysis of three randomised, double-masked six-month clinical studies comparing the intraocular pressure reducing effect of latanoprost and timolol
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience.
2000 (English)In: European Journal of Ophthalmology, ISSN 1120-6721, Vol. 10, no 2, 95-104 p.Article in journal (Refereed) Published
Abstract [en]


To compare the intraocular pressure (IOP) reduction by latanoprost and timolol, and to study factors of prognostic value for assessing this reduction.


We analyzed 829 patients included in three phase 111 studies comparing six months' treatment with 0.005% latanoprost once daily and 0.5% timolol twice daily in patients with open-angle glaucoma or ocular hypertension. Analysis of covariance controlled for differences in baseline IOP and sex was used to assess the IOP reduction.


Latanoprost reduced diurnal IOP (average of morning, noon and afternoon assessments) by 7.7 mmHg (31%) and timolol by 6.5 mmHg (26%) after six months of treatment. Thus the diurnal IOP was reduced 1.2 mmHg (18%) more with latanoprost than with timolol (p<0.001). Latanoprost-treated patients showed a further decrease in morning IOP of 0.7 mmHg (9%, p<0.001) from the initial morning IOP reduction obtained at two weeks. No such further decrease in IOP was seen with timolol. Higher baseline diurnal IOP resulted in a larger diurnal reduction during treatment with both drugs (p<0.001). Diurnal IOP in women was reduced 0.7 mmHg (11%) less than males with both drugs (p<0.001).


Latanoprost was more effective than timolol in reducing mean diurnal IOP. The effect after two weeks was maintained for timolol while with latanoprost there was a further, significant IOP reduction from two weeks to six months. Baseline IOP was the only factor of clinical importance found to be of prognostic value for assessing the IOP reduction.

Place, publisher, year, edition, pages
2000. Vol. 10, no 2, 95-104 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-90322PubMedID: 10887918OAI: oai:DiVA.org:uu-90322DiVA: diva2:162634
Available from: 2003-04-07 Created: 2003-04-07 Last updated: 2013-03-21Bibliographically approved
In thesis
1. Pooling Data from Similar Randomized Clinical Trials Comparing Latanoprost with Timolol; Medical Results and Statistical Aspects
Open this publication in new window or tab >>Pooling Data from Similar Randomized Clinical Trials Comparing Latanoprost with Timolol; Medical Results and Statistical Aspects
2003 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Two different principles were studied. 1st - statistical analysis techniques were used to obtain medical results from a patient population. 2nd - the patient population was used to study the statistical analysis techniques.

Medical conclusions: latanoprost and timolol treatment showed a statistically significant and clinically useful mean IOP-reduction in a typical worldwide clinical trial population. Latanoprost reduced the IOP 1.6 mm Hg more than timolol. The IOP-reduction was maintained with timolol and slightly enforced with latanoprost up to 6 months of treatment. The mean IOP-reduction was maintained during 2 years of latanoprost treatment. The overall risk of withdrawal due to insufficient IOP-reduction with latanoprost was 8%.

The statistical methodological issues are of a general and reoccurring character in trial design of the IOP-reduction: should the statistical hypothesis testing be based on the mean intraocular pressure (IOP) or the proportion of patients who reach a specific IOP level, should the estimate of the IOP or IOP-reduction be based on single eyes, mean of bilaterally eligible and identically treated eyes or the difference between an eye with active treatment and a placebo treated contralateral eye, and is mean of replicated recordings useful? Statistical methodological conclusions: the most effective response variable varies with the selected patient population. Therefore, the trial design process should include a comparison of the variability, test power and required sample size for the possible response variables in a sample of the target population. At minimum a statistical consideration should be done.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2003. 54 p.
Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 0282-7476 ; 1235
Ophtalmology, mean intraocular pressure, target intraocular pressure, latanoprost, timolol, open-angle glaucoma, ocular hypertension, trial design, Oftalmiatrik
National Category
Research subject
urn:nbn:se:uu:diva-3392 (URN)91-554-5570-0 (ISBN)
Public defence
2003-05-03, Grönwallsalen, Uppsala University Hospital, entrance 70, Uppsala, 13:15
Available from: 2003-04-07 Created: 2003-04-07Bibliographically approved

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