A study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension
Douglas J Rhee1, James H Peace2, Sushanta Mallick3, Theresa A Landry3, Michael VW Bergamini3, and the Study Group*1Massachusetts Eye and Ear Infirmary, Harvard University, Boston, MA, USA; 2Diabetic Eye Medical Clinic, Inglewood, CA, USA; 3Alcon Laboratories, Inc., Ft. Worth, TX, USA; *Study Group m...
Guardado en:
| Autores principales: | , , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Dove Medical Press
2008
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/10e7bb7c3abb42b98af0adbb5a0790c5 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:10e7bb7c3abb42b98af0adbb5a0790c5 |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:10e7bb7c3abb42b98af0adbb5a0790c52021-12-02T05:00:50ZA study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension1177-54671177-5483https://doaj.org/article/10e7bb7c3abb42b98af0adbb5a0790c52008-06-01T00:00:00Zhttp://www.dovepress.com/a-study-of-the-safety-and-efficacy-of-travoprost-0004timolol-05-ophtha-a1786https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Douglas J Rhee1, James H Peace2, Sushanta Mallick3, Theresa A Landry3, Michael VW Bergamini3, and the Study Group*1Massachusetts Eye and Ear Infirmary, Harvard University, Boston, MA, USA; 2Diabetic Eye Medical Clinic, Inglewood, CA, USA; 3Alcon Laboratories, Inc., Ft. Worth, TX, USA; *Study Group members listed in AppendixBackground/Aims: To compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% in fixed combination with the unfixed combination of latanoprost 0.005% and timolol 0.5% in open-angle glaucoma or ocular hypertension patients with IOP levels below 18 mmHg on the unfixed combination of latanoprost 0.005% and timolol 0.5%.Methods: Following a 30-day open-label run-in with latanoprost QD PM and timolol QD AM, subjects with intraocular pressure below 18 mmHg were randomized to continue concomitant latanoprost QD PM and timolol QD AM or switch to travoprost 0.004%/timolol 0.5% QD AM and vehicle QD PM in masked fashion and were followed for 3 months. The primary efficacy endpoint was mean IOP reduction from baseline.Results: There were no clinically relevant or statistically significant differences in mean IOP, mean IOP change from baseline, or percentage IOP change from baseline between the two treatment groups. Between-group differences in mean IOP were within ±0.3 mmHg at all time points (p ≥ 0.384), and between-group differences in mean IOP change from baseline were within ±0.4 mmHg at all time points. Overall, 88% of patients whose IOP was less than 18 mmHg on the unfixed combination of latanoprost and timolol remained well controlled on the same regimen in the masked portion of the study, compared with 92% who remained well controlled after switching to travoprost/timolol.Conclusion: Travoprost 0.004%/timolol 0.5% administered once daily and concomitant administration of timolol 0.5% and latanoprost 0.005% produce similar maintenance of IOP-lowering effect in patients who were previously well controlled on concomitant administration of latanoprost and timolol. Patients who are well controlled on latanoprost and timolol concomitant therapy can be switched to once-daily therapy with travoprost 0.004%/timolol 0.5% with no expected compromise in the safety and efficacy of their treatment.Keywords: travoprost, timolol, glaucoma, intraocular pressure, fixed combination Douglas J RheeJames H PeaceSushanta MallickTheresa A LandryMichael VW Bergaminithe Study Group*Dove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2008, Iss Issue 2, Pp 313-319 (2008) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Ophthalmology RE1-994 |
| spellingShingle |
Ophthalmology RE1-994 Douglas J Rhee James H Peace Sushanta Mallick Theresa A Landry Michael VW Bergamini the Study Group* A study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension |
| description |
Douglas J Rhee1, James H Peace2, Sushanta Mallick3, Theresa A Landry3, Michael VW Bergamini3, and the Study Group*1Massachusetts Eye and Ear Infirmary, Harvard University, Boston, MA, USA; 2Diabetic Eye Medical Clinic, Inglewood, CA, USA; 3Alcon Laboratories, Inc., Ft. Worth, TX, USA; *Study Group members listed in AppendixBackground/Aims: To compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% in fixed combination with the unfixed combination of latanoprost 0.005% and timolol 0.5% in open-angle glaucoma or ocular hypertension patients with IOP levels below 18 mmHg on the unfixed combination of latanoprost 0.005% and timolol 0.5%.Methods: Following a 30-day open-label run-in with latanoprost QD PM and timolol QD AM, subjects with intraocular pressure below 18 mmHg were randomized to continue concomitant latanoprost QD PM and timolol QD AM or switch to travoprost 0.004%/timolol 0.5% QD AM and vehicle QD PM in masked fashion and were followed for 3 months. The primary efficacy endpoint was mean IOP reduction from baseline.Results: There were no clinically relevant or statistically significant differences in mean IOP, mean IOP change from baseline, or percentage IOP change from baseline between the two treatment groups. Between-group differences in mean IOP were within ±0.3 mmHg at all time points (p ≥ 0.384), and between-group differences in mean IOP change from baseline were within ±0.4 mmHg at all time points. Overall, 88% of patients whose IOP was less than 18 mmHg on the unfixed combination of latanoprost and timolol remained well controlled on the same regimen in the masked portion of the study, compared with 92% who remained well controlled after switching to travoprost/timolol.Conclusion: Travoprost 0.004%/timolol 0.5% administered once daily and concomitant administration of timolol 0.5% and latanoprost 0.005% produce similar maintenance of IOP-lowering effect in patients who were previously well controlled on concomitant administration of latanoprost and timolol. Patients who are well controlled on latanoprost and timolol concomitant therapy can be switched to once-daily therapy with travoprost 0.004%/timolol 0.5% with no expected compromise in the safety and efficacy of their treatment.Keywords: travoprost, timolol, glaucoma, intraocular pressure, fixed combination |
| format |
article |
| author |
Douglas J Rhee James H Peace Sushanta Mallick Theresa A Landry Michael VW Bergamini the Study Group* |
| author_facet |
Douglas J Rhee James H Peace Sushanta Mallick Theresa A Landry Michael VW Bergamini the Study Group* |
| author_sort |
Douglas J Rhee |
| title |
A study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension |
| title_short |
A study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension |
| title_full |
A study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension |
| title_fullStr |
A study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension |
| title_full_unstemmed |
A study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension |
| title_sort |
study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension |
| publisher |
Dove Medical Press |
| publishDate |
2008 |
| url |
https://doaj.org/article/10e7bb7c3abb42b98af0adbb5a0790c5 |
| work_keys_str_mv |
AT douglasjrhee astudyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT jameshpeace astudyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT sushantamallick astudyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT theresaalandry astudyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT michaelvwbergamini astudyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT thestudygroup astudyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT douglasjrhee studyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT jameshpeace studyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT sushantamallick studyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT theresaalandry studyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT michaelvwbergamini studyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension AT thestudygroup studyofthesafetyandefficacyoftravoprost0004timolol05ophthalmicsolutioncomparedtolatanoprost0005andtimolol05dosedconcomitantlyinpatientswithopenangleglaucomaorocularhypertension |
| _version_ |
1718400813100957696 |