A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease
Joseph Tauber,1 Barry A Schechter,2 Jason Bacharach,3 Melissa M Toyos,4 Robert Smyth-Medina,5 Sidney L Weiss,6 Jodi I Luchs7 1Tauber Eye Center, Kansas City, MO, USA; 2Florida Eye Microsurgical Institute, Boynton Beach, FL, USA; 3North Bay Eye Associates, Petaluma, CA, USA; 4Toyos Clinic, Nashville...
Main Authors: | , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Dove Medical Press
2018-10-01
|
Series: | Clinical Ophthalmology |
Subjects: | |
Online Access: | https://www.dovepress.com/a-phase-iiiii-randomized-double-masked-vehicle-controlled-dose-ranging-peer-reviewed-article-OPTH |
id |
doaj-d3081699ac5545039b3bca544fc4d571 |
---|---|
record_format |
Article |
spelling |
doaj-d3081699ac5545039b3bca544fc4d5712020-11-25T02:28:55ZengDove Medical PressClinical Ophthalmology1177-54832018-10-01Volume 121921192941053A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye diseaseTauber JSchechter BABacharach JToyos MMSmyth-Medina RWeiss SLLuchs JIJoseph Tauber,1 Barry A Schechter,2 Jason Bacharach,3 Melissa M Toyos,4 Robert Smyth-Medina,5 Sidney L Weiss,6 Jodi I Luchs7 1Tauber Eye Center, Kansas City, MO, USA; 2Florida Eye Microsurgical Institute, Boynton Beach, FL, USA; 3North Bay Eye Associates, Petaluma, CA, USA; 4Toyos Clinic, Nashville, TN, USA; 5North Valley Eye Medical Group, Mission Hills, CA, USA; 6i-Novion, Inc, Randolph, NJ, USA; 7South Shore Eye Care, Wantagh, NY, USA Purpose: The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED).Patients and methods: This was a 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging clinical trial. Subjects were adults aged ≥18 years, with a total conjunctival staining score of ≥3 and ≤9, and global DED symptom score ≥40 (0–100 visual analogue scale). Following a 14-day vehicle run-in, subjects were randomized in a 1:1:1 ratio to twice daily treatment with OTX-101 0.09%, OTX-101 0.05%, or vehicle for 84 days. Co-primary efficacy end points were changes, from baseline to Day 84, in the total lissamine green conjunctival staining score in the designated study eye and in the global symptom score (both eyes). Secondary end points included total corneal fluorescein staining score, tear breakup time, and Schirmer’s test score.Results: In total, 455 subjects were randomized. Subjects treated with active drug experienced greater improvement in conjunctival staining than vehicle-treated patients (P<0.01 for both concentrations). All groups demonstrated improvements in global symptom score, but there were no differences among groups. Nominally significant differences were found between the active drug arms and vehicle for corneal staining scores and Schirmer’s test scores. Most treatment-emergent adverse events were mild in severity; no serious ocular adverse events were reported.Conclusions: Both concentrations of OTX-101 met the co-primary sign end point (conjunctival staining) but not the co-primary symptom end point. OTX-101 0.09% demonstrated a notable impact on multiple signs of DED relative to vehicle and was well-tolerated. Keywords: dry eye disease, cyclosporine, inflammation, Schirmer’s testhttps://www.dovepress.com/a-phase-iiiii-randomized-double-masked-vehicle-controlled-dose-ranging-peer-reviewed-article-OPTHDry eye diseasecyclosporineinflammationSchirmer test |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Tauber J Schechter BA Bacharach J Toyos MM Smyth-Medina R Weiss SL Luchs JI |
spellingShingle |
Tauber J Schechter BA Bacharach J Toyos MM Smyth-Medina R Weiss SL Luchs JI A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease Clinical Ophthalmology Dry eye disease cyclosporine inflammation Schirmer test |
author_facet |
Tauber J Schechter BA Bacharach J Toyos MM Smyth-Medina R Weiss SL Luchs JI |
author_sort |
Tauber J |
title |
A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease |
title_short |
A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease |
title_full |
A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease |
title_fullStr |
A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease |
title_full_unstemmed |
A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease |
title_sort |
phase ii/iii, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of otx-101 in the treatment of dry eye disease |
publisher |
Dove Medical Press |
series |
Clinical Ophthalmology |
issn |
1177-5483 |
publishDate |
2018-10-01 |
description |
Joseph Tauber,1 Barry A Schechter,2 Jason Bacharach,3 Melissa M Toyos,4 Robert Smyth-Medina,5 Sidney L Weiss,6 Jodi I Luchs7 1Tauber Eye Center, Kansas City, MO, USA; 2Florida Eye Microsurgical Institute, Boynton Beach, FL, USA; 3North Bay Eye Associates, Petaluma, CA, USA; 4Toyos Clinic, Nashville, TN, USA; 5North Valley Eye Medical Group, Mission Hills, CA, USA; 6i-Novion, Inc, Randolph, NJ, USA; 7South Shore Eye Care, Wantagh, NY, USA Purpose: The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED).Patients and methods: This was a 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging clinical trial. Subjects were adults aged ≥18 years, with a total conjunctival staining score of ≥3 and ≤9, and global DED symptom score ≥40 (0–100 visual analogue scale). Following a 14-day vehicle run-in, subjects were randomized in a 1:1:1 ratio to twice daily treatment with OTX-101 0.09%, OTX-101 0.05%, or vehicle for 84 days. Co-primary efficacy end points were changes, from baseline to Day 84, in the total lissamine green conjunctival staining score in the designated study eye and in the global symptom score (both eyes). Secondary end points included total corneal fluorescein staining score, tear breakup time, and Schirmer’s test score.Results: In total, 455 subjects were randomized. Subjects treated with active drug experienced greater improvement in conjunctival staining than vehicle-treated patients (P<0.01 for both concentrations). All groups demonstrated improvements in global symptom score, but there were no differences among groups. Nominally significant differences were found between the active drug arms and vehicle for corneal staining scores and Schirmer’s test scores. Most treatment-emergent adverse events were mild in severity; no serious ocular adverse events were reported.Conclusions: Both concentrations of OTX-101 met the co-primary sign end point (conjunctival staining) but not the co-primary symptom end point. OTX-101 0.09% demonstrated a notable impact on multiple signs of DED relative to vehicle and was well-tolerated. Keywords: dry eye disease, cyclosporine, inflammation, Schirmer’s test |
topic |
Dry eye disease cyclosporine inflammation Schirmer test |
url |
https://www.dovepress.com/a-phase-iiiii-randomized-double-masked-vehicle-controlled-dose-ranging-peer-reviewed-article-OPTH |
work_keys_str_mv |
AT tauberj aphaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT schechterba aphaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT bacharachj aphaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT toyosmm aphaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT smythmedinar aphaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT weisssl aphaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT luchsji aphaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT tauberj phaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT schechterba phaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT bacharachj phaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT toyosmm phaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT smythmedinar phaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT weisssl phaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease AT luchsji phaseiiiiirandomizeddoublemaskedvehiclecontrolleddoserangingstudyofthesafetyandefficacyofotx101inthetreatmentofdryeyedisease |
_version_ |
1724835633276387328 |