Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial

Ingeborg Stalmans, Francesco Oddone, Maria Francesca Cordeiro, Anton Hommer, Giovanni Montesano, Luisa Ribeiro, Gordana Sunaric-Mégevand, Luca Rossetti

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Purpose: The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF). Methods: A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment. Results: Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p <0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF – BUDPF) was observed (p <0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: −4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p <0.01 for both drugs; p = 0.32 between the two drugs); −5.2 ± 0.5 and −3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p <0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs). Conclusions: This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.

Original languageEnglish
Pages (from-to)1151-1158
Number of pages8
JournalGraefe's Archive for Clinical and Experimental Ophthalmology
Volume254
Issue number6
DOIs
Publication statusPublished - 2016

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latanoprost
Cross-Over Studies
Intraocular Pressure
Research Personnel
Clinical Trials
Pharmaceutical Preparations
Safety
Ocular Hypertension
Bimatoprost
Open Angle Glaucoma
Hyperemia
Optic Nerve

Keywords

  • Bimatoprost
  • Cross-over
  • Latanoprost
  • Preservative-free
  • Prostaglandin

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial. / Stalmans, Ingeborg; Oddone, Francesco; Cordeiro, Maria Francesca; Hommer, Anton; Montesano, Giovanni; Ribeiro, Luisa; Sunaric-Mégevand, Gordana; Rossetti, Luca.

In: Graefe's Archive for Clinical and Experimental Ophthalmology, Vol. 254, No. 6, 2016, p. 1151-1158.

Research output: Contribution to journalArticle

Stalmans, Ingeborg ; Oddone, Francesco ; Cordeiro, Maria Francesca ; Hommer, Anton ; Montesano, Giovanni ; Ribeiro, Luisa ; Sunaric-Mégevand, Gordana ; Rossetti, Luca. / Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial. In: Graefe's Archive for Clinical and Experimental Ophthalmology. 2016 ; Vol. 254, No. 6. pp. 1151-1158.
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title = "Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial",
abstract = "Purpose: The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF). Methods: A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment. Results: Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p <0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF – BUDPF) was observed (p <0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: −4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p <0.01 for both drugs; p = 0.32 between the two drugs); −5.2 ± 0.5 and −3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p <0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs). Conclusions: This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.",
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AU - Oddone, Francesco

AU - Cordeiro, Maria Francesca

AU - Hommer, Anton

AU - Montesano, Giovanni

AU - Ribeiro, Luisa

AU - Sunaric-Mégevand, Gordana

AU - Rossetti, Luca

PY - 2016

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N2 - Purpose: The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF). Methods: A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment. Results: Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p <0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF – BUDPF) was observed (p <0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: −4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p <0.01 for both drugs; p = 0.32 between the two drugs); −5.2 ± 0.5 and −3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p <0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs). Conclusions: This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.

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