Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies
Raymond Fong,1 Megan E Cavet,2 Heleen H DeCory,2 Jason L Vittitow31Manhattan Eye, Ear and Throat Hospital and Lenox Hill Hospital, New York, NY, USA; 2Medical Affairs, Bausch + Lomb, Rochester, NY, USA; 3Clinical Affairs, Bausch + Lomb, Bridgewater, NJ, USAPurpose: To evaluate the efficacy and safet...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2019-08-01
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| Series: | Clinical Ophthalmology |
| Subjects: | |
| Online Access: | https://www.dovepress.com/loteprednol-etabonate-submicron-ophthalmic-gel-038-dosed-three-times-d-peer-reviewed-article-OPTH |
| _version_ | 1818901439309676544 |
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| author | Fong R Cavet ME DeCory HH Vittitow JL |
| author_facet | Fong R Cavet ME DeCory HH Vittitow JL |
| author_sort | Fong R |
| collection | DOAJ |
| description | Raymond Fong,1 Megan E Cavet,2 Heleen H DeCory,2 Jason L Vittitow31Manhattan Eye, Ear and Throat Hospital and Lenox Hill Hospital, New York, NY, USA; 2Medical Affairs, Bausch + Lomb, Rochester, NY, USA; 3Clinical Affairs, Bausch + Lomb, Bridgewater, NJ, USAPurpose: To evaluate the efficacy and safety of a submicron formulation of loteprednol etabonate (LE) gel 0.38% instilled three times daily (TID) compared with vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies.Patients and methods: Subjects ≥18 years of age with anterior chamber (AC) cells ≥grade 2 (6–15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. Primary endpoints were the proportion of subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy results, visual acuity, intraocular pressure (IOP), and tolerability (drop comfort and ocular symptoms).Results: The integrated intent-to-treat population included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly more subjects in the LE gel 0.38% TID group compared with the vehicle group had complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 48.8%) at day 8 (P<0.0001 for both). LE gel 0.38% TID was safe and well tolerated, with only 1 LE-treated subject experiencing an IOP elevation ≥10 mm Hg. Most treatment-related AEs were mild and occurred less frequently with LE gel 0.38% than with vehicle. The majority (>75%) of subjects in each treatment group reported no drop discomfort. There were no reports of blurred vision with LE gel.Conclusion: The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.Keywords: cataract surgery, postoperative pain, postoperative inflammation, loteprednol etabonate, submicron, integrated analysis |
| first_indexed | 2024-12-19T20:19:46Z |
| format | Article |
| id | doaj.art-ed55a3c09ee1443f974cda1fc0e060a2 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-12-19T20:19:46Z |
| publishDate | 2019-08-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-ed55a3c09ee1443f974cda1fc0e060a22022-12-21T20:07:02ZengDove Medical PressClinical Ophthalmology1177-54832019-08-01Volume 131427143847577Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studiesFong RCavet MEDeCory HHVittitow JLRaymond Fong,1 Megan E Cavet,2 Heleen H DeCory,2 Jason L Vittitow31Manhattan Eye, Ear and Throat Hospital and Lenox Hill Hospital, New York, NY, USA; 2Medical Affairs, Bausch + Lomb, Rochester, NY, USA; 3Clinical Affairs, Bausch + Lomb, Bridgewater, NJ, USAPurpose: To evaluate the efficacy and safety of a submicron formulation of loteprednol etabonate (LE) gel 0.38% instilled three times daily (TID) compared with vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies.Patients and methods: Subjects ≥18 years of age with anterior chamber (AC) cells ≥grade 2 (6–15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. Primary endpoints were the proportion of subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy results, visual acuity, intraocular pressure (IOP), and tolerability (drop comfort and ocular symptoms).Results: The integrated intent-to-treat population included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly more subjects in the LE gel 0.38% TID group compared with the vehicle group had complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 48.8%) at day 8 (P<0.0001 for both). LE gel 0.38% TID was safe and well tolerated, with only 1 LE-treated subject experiencing an IOP elevation ≥10 mm Hg. Most treatment-related AEs were mild and occurred less frequently with LE gel 0.38% than with vehicle. The majority (>75%) of subjects in each treatment group reported no drop discomfort. There were no reports of blurred vision with LE gel.Conclusion: The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.Keywords: cataract surgery, postoperative pain, postoperative inflammation, loteprednol etabonate, submicron, integrated analysishttps://www.dovepress.com/loteprednol-etabonate-submicron-ophthalmic-gel-038-dosed-three-times-d-peer-reviewed-article-OPTHCataract surgeryPostoperative painPostoperative inflammationLoteprednol etabonateSubmicronIntegrated analysis |
| spellingShingle | Fong R Cavet ME DeCory HH Vittitow JL Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies Clinical Ophthalmology Cataract surgery Postoperative pain Postoperative inflammation Loteprednol etabonate Submicron Integrated analysis |
| title | Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies |
| title_full | Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies |
| title_fullStr | Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies |
| title_full_unstemmed | Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies |
| title_short | Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies |
| title_sort | loteprednol etabonate submicron ophthalmic gel 0 38 dosed three times daily following cataract surgery integrated analysis of two phase iii clinical studies |
| topic | Cataract surgery Postoperative pain Postoperative inflammation Loteprednol etabonate Submicron Integrated analysis |
| url | https://www.dovepress.com/loteprednol-etabonate-submicron-ophthalmic-gel-038-dosed-three-times-d-peer-reviewed-article-OPTH |
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