TY - JOUR
T1 - Comparison of preserved bimatoprost 0.01% with preservative-free tafluprost
T2 - A randomised, investigator-masked, 3-month crossover, multicentre trial, SPORT II
AU - Lemmens, Sophie
AU - Rossetti, Luca
AU - Oddone, Francesco
AU - Sunaric-Mégevand, Gordana
AU - Hommer, Anton
AU - Vandewalle, Evelien
AU - Francesca Cordeiro, Maria
AU - McNaught, Andrew
AU - Montesano, Giovanni
AU - Stalmans, Ingeborg
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This investigator-initiated study was sponsored by UZ Leuven, Belgium. Allergan provided financial support in the form of an unrestricted grant to UZ Leuven (grant number IIT-2017-10133). Dalton & Associates, Inc., provided writing and editorial support; this support was funded by Allergan.
Funding Information:
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Some of the authors have received financial support from companies that have interest in the subject of this study: consultancy fees (MFC, GSM, TH, AM, FO, LR, IS from Allergan, MFC, AM, IS, GSM from Théa Pharma and LR, IS from Alcon, LR, FO from Omikron and FO, IS from Santen; LR from Centervue, NTC and Sooft; AM and IS from Aerie, IS from EyeD Pharma, EyeTechCare), honoraria for lectures (FC, GSM, TH, LR, IS from Allergan, MFC, FO, IS from Théa Pharma, MFC, FO, LR, IS from Santen, LR, FO from Omikron, FO from Novartis and LR from Alcon, Centervue and Visufarma) and educational grants (LR, GM, FO, IS from Allergan, FO, LR from Omikron, Santen). The contribution of the IRCCS Fondazione Bietti in this paper was supported by the Italian Ministry of Health and by Fondazione Roma.
Publisher Copyright:
© The Author(s) 2021.
PY - 2022/3
Y1 - 2022/3
N2 - Importance: This study compares the efficacy and tolerability of a preservative-free prostaglandin analogue (tafluprost 15 mg/ml) to a prostaglandin analogue that uses 0.02% of benzalkonium chloride (bimatoprost 0.1 mg/ml). Background: Different prostaglandin analogues have been commercially approved, with differences in tolerability. Design: Prospective, randomised, investigator-masked, 3-month crossover, multicentre trial. Participants: Sixty-four patients with ocular hypertension or open-angle glaucoma were randomised to two groups, after a 4-week washout period from their current topical drop regimen. Methods: Participants were randomised to tafluprost (Group 1; n = 33) or bimatoprost (Group 2; n = 31). At month 3, each group switched to the opposite treatment. IOP was evaluated at multiple timepoints. Main outcome measures: The primary outcome was difference in mean IOP between the two groups at the final visit. Secondary outcomes included change from baseline IOP at month 3 and month 6, difference in mean IOP at month 3 and difference in IOP at all timepoints. Safety outcomes included best-corrected visual acuity (BCVA), adverse events, ocular tolerability, optic nerve assessment and slit lamp biomicroscopy. Results: Both medications significantly lowered IOP at month 6 compared to baseline: 5.4 mmHg (27%) for tafluprost and 6.8 mmHg (33%) for bimatoprost (p < 0.0001). No significant differences in any of the safety measures (including conjunctival hypearemia) were detected. Conclusions and relevance: Bimatoprost produced a statistically significant greater IOP reduction compared to tafluprost with minimal to no difference in side effects. This should be borne in mind when weighing up the pros and cons of preserved versus preservative-free prostaglandin analogue therapy. ClinicalTrials.gov Identifier: NCT02471105.
AB - Importance: This study compares the efficacy and tolerability of a preservative-free prostaglandin analogue (tafluprost 15 mg/ml) to a prostaglandin analogue that uses 0.02% of benzalkonium chloride (bimatoprost 0.1 mg/ml). Background: Different prostaglandin analogues have been commercially approved, with differences in tolerability. Design: Prospective, randomised, investigator-masked, 3-month crossover, multicentre trial. Participants: Sixty-four patients with ocular hypertension or open-angle glaucoma were randomised to two groups, after a 4-week washout period from their current topical drop regimen. Methods: Participants were randomised to tafluprost (Group 1; n = 33) or bimatoprost (Group 2; n = 31). At month 3, each group switched to the opposite treatment. IOP was evaluated at multiple timepoints. Main outcome measures: The primary outcome was difference in mean IOP between the two groups at the final visit. Secondary outcomes included change from baseline IOP at month 3 and month 6, difference in mean IOP at month 3 and difference in IOP at all timepoints. Safety outcomes included best-corrected visual acuity (BCVA), adverse events, ocular tolerability, optic nerve assessment and slit lamp biomicroscopy. Results: Both medications significantly lowered IOP at month 6 compared to baseline: 5.4 mmHg (27%) for tafluprost and 6.8 mmHg (33%) for bimatoprost (p < 0.0001). No significant differences in any of the safety measures (including conjunctival hypearemia) were detected. Conclusions and relevance: Bimatoprost produced a statistically significant greater IOP reduction compared to tafluprost with minimal to no difference in side effects. This should be borne in mind when weighing up the pros and cons of preserved versus preservative-free prostaglandin analogue therapy. ClinicalTrials.gov Identifier: NCT02471105.
KW - Prostaglandin
KW - bimatoprost
KW - crossover
KW - preservative-free
KW - tafluprost
UR - http://www.scopus.com/inward/record.url?scp=85103621056&partnerID=8YFLogxK
U2 - 10.1177/11206721211006573
DO - 10.1177/11206721211006573
M3 - Article
AN - SCOPUS:85103621056
VL - 32
SP - 968
EP - 975
JO - European Journal of Ophthalmology
JF - European Journal of Ophthalmology
SN - 1120-6721
IS - 2
ER -