Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution
Victor H Gonzalez,1 David L Wirta,2 Martin Uram,3 Audrey Schupp,4 Michelle Widmann,5 Gary D Novack6,7 1Valley Research Institute, McAllen, TX, USA; 2Eye Research Foundation, Newport Beach, CA, USA; 3American Genomics, LLC, Hobe Sound, FL, USA; 4CMC Turnkey Solutions, Bailey, CO, USA; 5Cal Clinical S...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2023-05-01
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| Series: | Clinical Ophthalmology |
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| Online Access: | https://www.dovepress.com/two-randomized-double-masked-placebo-controlled-studies-of-the-local-a-peer-reviewed-fulltext-article-OPTH |
| _version_ | 1827949859390357504 |
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| author | Gonzalez VH Wirta DL Uram M Schupp A Widmann M Novack GD |
| author_facet | Gonzalez VH Wirta DL Uram M Schupp A Widmann M Novack GD |
| author_sort | Gonzalez VH |
| collection | DOAJ |
| description | Victor H Gonzalez,1 David L Wirta,2 Martin Uram,3 Audrey Schupp,4 Michelle Widmann,5 Gary D Novack6,7 1Valley Research Institute, McAllen, TX, USA; 2Eye Research Foundation, Newport Beach, CA, USA; 3American Genomics, LLC, Hobe Sound, FL, USA; 4CMC Turnkey Solutions, Bailey, CO, USA; 5Cal Clinical Solutions, Apex, NC, USA; 6PharmaLogic Development, Inc., San Rafael, CA, USA; 7Department of Ophthalmology & Vision Science, University of California, Davis, School of Medicine, Sacramento, CA, USACorrespondence: Gary D Novack, PharmaLogic Development, Inc., 17 Bridgegate Drive, San Rafael, CA, 94903, USA, Tel +1 415 472-2181, Email gary_novack@pharmalogic.comBackground: We wanted to develop a new topical ocular anesthetic with good bioavailability in anterior segment tissues. Given concerns about contamination and sterility in multi-dose products, we selected a unit-dose, nonpreserved presentation of AG-920 (articaine ophthalmic solution) in blow-fill-seal containers (similar to currently marketed pharmacological therapies for dry eye disease).Methods: Consistent with US Food and Drug Administration guidance, two pivotal, Phase 3, randomized, placebo-controlled, double-masked, parallel design studies conducted at two US private practices in 240 healthy subjects. A single dose of AG-920 or identical looking placebo into one (study) eye (2 drops 30 s apart). Subjects underwent a conjunctival pinch procedure and assessment of the pain associated with the pinch. The main outcome measure was the proportion of subjects with rating of “No pain at 5 minutes”.Results: AG-920 provided a rapid onset of local anesthesia (less than one minute) with clinically and statistically significantly greater effect in AG-920 (68% and 83%) than placebo (3% and 18% for Study 1 and Study 2, respectively, P< 0.0001). The most frequent adverse event was instillation site pain (27% vs 3%) followed by conjunctival hyperemia (probably related to the pinch, 9% vs 10%) in the AG-920 and placebo groups, respectively.Conclusion: AG-920 was found to be have a rapid onset and useful duration of local anesthesia with no major safety issues, and may be useful for the eye-care professional. Registered with clinicaltrials.gov as NCT04513652 and NCT04829344.Keywords: local anesthesia, articaine, controlled trial |
| first_indexed | 2024-04-09T13:16:25Z |
| format | Article |
| id | doaj.art-2f37a94c9e1749a9bc4954f4d21d3d10 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-04-09T13:16:25Z |
| publishDate | 2023-05-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-2f37a94c9e1749a9bc4954f4d21d3d102023-05-11T18:59:32ZengDove Medical PressClinical Ophthalmology1177-54832023-05-01Volume 171357136583659Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic SolutionGonzalez VHWirta DLUram MSchupp AWidmann MNovack GDVictor H Gonzalez,1 David L Wirta,2 Martin Uram,3 Audrey Schupp,4 Michelle Widmann,5 Gary D Novack6,7 1Valley Research Institute, McAllen, TX, USA; 2Eye Research Foundation, Newport Beach, CA, USA; 3American Genomics, LLC, Hobe Sound, FL, USA; 4CMC Turnkey Solutions, Bailey, CO, USA; 5Cal Clinical Solutions, Apex, NC, USA; 6PharmaLogic Development, Inc., San Rafael, CA, USA; 7Department of Ophthalmology & Vision Science, University of California, Davis, School of Medicine, Sacramento, CA, USACorrespondence: Gary D Novack, PharmaLogic Development, Inc., 17 Bridgegate Drive, San Rafael, CA, 94903, USA, Tel +1 415 472-2181, Email gary_novack@pharmalogic.comBackground: We wanted to develop a new topical ocular anesthetic with good bioavailability in anterior segment tissues. Given concerns about contamination and sterility in multi-dose products, we selected a unit-dose, nonpreserved presentation of AG-920 (articaine ophthalmic solution) in blow-fill-seal containers (similar to currently marketed pharmacological therapies for dry eye disease).Methods: Consistent with US Food and Drug Administration guidance, two pivotal, Phase 3, randomized, placebo-controlled, double-masked, parallel design studies conducted at two US private practices in 240 healthy subjects. A single dose of AG-920 or identical looking placebo into one (study) eye (2 drops 30 s apart). Subjects underwent a conjunctival pinch procedure and assessment of the pain associated with the pinch. The main outcome measure was the proportion of subjects with rating of “No pain at 5 minutes”.Results: AG-920 provided a rapid onset of local anesthesia (less than one minute) with clinically and statistically significantly greater effect in AG-920 (68% and 83%) than placebo (3% and 18% for Study 1 and Study 2, respectively, P< 0.0001). The most frequent adverse event was instillation site pain (27% vs 3%) followed by conjunctival hyperemia (probably related to the pinch, 9% vs 10%) in the AG-920 and placebo groups, respectively.Conclusion: AG-920 was found to be have a rapid onset and useful duration of local anesthesia with no major safety issues, and may be useful for the eye-care professional. Registered with clinicaltrials.gov as NCT04513652 and NCT04829344.Keywords: local anesthesia, articaine, controlled trialhttps://www.dovepress.com/two-randomized-double-masked-placebo-controlled-studies-of-the-local-a-peer-reviewed-fulltext-article-OPTHlocal anesthesia – articaine – controlled trial |
| spellingShingle | Gonzalez VH Wirta DL Uram M Schupp A Widmann M Novack GD Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution Clinical Ophthalmology local anesthesia – articaine – controlled trial |
| title | Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution |
| title_full | Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution |
| title_fullStr | Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution |
| title_full_unstemmed | Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution |
| title_short | Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution |
| title_sort | two randomized double masked placebo controlled studies of the local anesthetic effect of articaine ophthalmic solution |
| topic | local anesthesia – articaine – controlled trial |
| url | https://www.dovepress.com/two-randomized-double-masked-placebo-controlled-studies-of-the-local-a-peer-reviewed-fulltext-article-OPTH |
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