Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension

A 12-week, randomised, double-masked trial

Douglas G. Day, Thomas R. Walters, Gail Schwartz, Thomas K. Mundorf, Charlie Liu, Rhett M. Schiffman, Marina Bejanian

Research output: Contribution to journalArticle

Abstract

Background/Aim: To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods: In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results: 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points ( p<0.001), were safe and well tolerated. Conclusions: Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

Original languageEnglish (US)
Pages (from-to)989-993
Number of pages5
JournalBritish Journal of Ophthalmology
Volume97
Issue number8
DOIs
StatePublished - Aug 1 2013

Fingerprint

Ocular Hypertension
compound A 12
Ophthalmic Solutions
Glaucoma
Intraocular Pressure
Bimatoprost
Safety
Double-Blind Method
Population

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension : A 12-week, randomised, double-masked trial. / Day, Douglas G.; Walters, Thomas R.; Schwartz, Gail; Mundorf, Thomas K.; Liu, Charlie; Schiffman, Rhett M.; Bejanian, Marina.

In: British Journal of Ophthalmology, Vol. 97, No. 8, 01.08.2013, p. 989-993.

Research output: Contribution to journalArticle

Day, Douglas G. ; Walters, Thomas R. ; Schwartz, Gail ; Mundorf, Thomas K. ; Liu, Charlie ; Schiffman, Rhett M. ; Bejanian, Marina. / Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension : A 12-week, randomised, double-masked trial. In: British Journal of Ophthalmology. 2013 ; Vol. 97, No. 8. pp. 989-993.
@article{d5e3191609244b5d8c189bd3de507b90,
title = "Bimatoprost 0.03{\%} preservative-free ophthalmic solution versus bimatoprost 0.03{\%} ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: A 12-week, randomised, double-masked trial",
abstract = "Background/Aim: To evaluate efficacy and safety of bimatoprost 0.03{\%} preservative-free (PF) ophthalmic solution versus bimatoprost 0.03{\%} (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods: In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results: 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95{\%} CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95{\%} CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points ( p<0.001), were safe and well tolerated. Conclusions: Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.",
author = "Day, {Douglas G.} and Walters, {Thomas R.} and Gail Schwartz and Mundorf, {Thomas K.} and Charlie Liu and Schiffman, {Rhett M.} and Marina Bejanian",
year = "2013",
month = "8",
day = "1",
doi = "10.1136/bjophthalmol-2012-303040",
language = "English (US)",
volume = "97",
pages = "989--993",
journal = "British Journal of Ophthalmology",
issn = "0007-1161",
publisher = "BMJ Publishing Group",
number = "8",

}

TY - JOUR

T1 - Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension

T2 - A 12-week, randomised, double-masked trial

AU - Day, Douglas G.

AU - Walters, Thomas R.

AU - Schwartz, Gail

AU - Mundorf, Thomas K.

AU - Liu, Charlie

AU - Schiffman, Rhett M.

AU - Bejanian, Marina

PY - 2013/8/1

Y1 - 2013/8/1

N2 - Background/Aim: To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods: In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results: 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points ( p<0.001), were safe and well tolerated. Conclusions: Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

AB - Background/Aim: To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods: In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results: 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points ( p<0.001), were safe and well tolerated. Conclusions: Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

UR - http://www.scopus.com/inward/record.url?scp=84880029235&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84880029235&partnerID=8YFLogxK

U2 - 10.1136/bjophthalmol-2012-303040

DO - 10.1136/bjophthalmol-2012-303040

M3 - Article

VL - 97

SP - 989

EP - 993

JO - British Journal of Ophthalmology

JF - British Journal of Ophthalmology

SN - 0007-1161

IS - 8

ER -