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

  • Glaucoma
  • Published:
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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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Authors and Affiliations

  1. Department of Ophthalmology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium

    Ingeborg Stalmans

  2. Glaucoma Research Unit, G.B.Bietti Eye Foundation - IRCCS, Via Livenza 3, 00198, Rome, Italy

    Francesco Oddone

  3. ICORG - Imperial College Ophthalmologic Research Group, Western Eye Hospital, 171 Marylebone Road, London, NW1 5QH, UK

    Maria Francesca Cordeiro

  4. Hommer Ophthalmology Institute, Albertgasse 39, A-1080, Vienna, Austria

    Anton Hommer

  5. Centre for Clinical Trials at San Paolo Hospital, University of Milan, via di Rudinì, 8, 20142, Milan, Italy

    Giovanni Montesano & Luca Rossetti

  6. AIBILI - Association for Innovation and Biomedical Research on Light and Image, Centre for Clinical Trials, Azinhaga Santa Comba, Celas, 3000-548, Coimbra, Portugal

    Luisa Ribeiro

  7. Clinical Research Center, Mèmorial A de Rotschild, 22 Chemin Beau Soleil, 1208, Geneva, Switzerland

    Gordana Sunaric-Mégevand

Authors
  1. Ingeborg Stalmans
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  2. Francesco Oddone
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  3. Maria Francesca Cordeiro
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  4. Anton Hommer
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  5. Giovanni Montesano
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  6. Luisa Ribeiro
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  7. Gordana Sunaric-Mégevand
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  8. Luca Rossetti
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Corresponding author

Correspondence to Ingeborg Stalmans.

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Funding

This investigator-initiated study was sponsored by the EVICR.net—European Vision Institute Clinical Research Network. Allergan provided financial support in the form of an unrestricted grant to EVICR.net.

Conflict of interest

Some of the authors have received financial support from companies that have interest in the subject of this study: consultancy fees (FC, GSM, TH, FO, LR, IS from Allergan and FC, IS, GSM from Théa pharma), honoraria for lectures (FC, GSM, TH, LR, IS from Allergan and FC, IS from Théa Pharma), and educational grants (LR, IS from Allergan, LR from Théa Pharma). The contribution of the IRCCS Fondazione Bietti in this paper was supported by the Italian Ministry of Health and by Fondazione Roma.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Stalmans, I., Oddone, F., Cordeiro, M.F. et al. Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial. Graefes Arch Clin Exp Ophthalmol 254, 1151–1158 (2016). https://doi.org/10.1007/s00417-016-3299-9

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  • DOI: https://doi.org/10.1007/s00417-016-3299-9

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