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- | libvatrep oral (SAF312) / Novartis
Journal: Ocular Pharmacology and Toxicology of TRPV1 Antagonist SAF312 (Libvatrep). (Pubmed Central) - Sep 8, 2023
SAF312 is a potent, selective, and noncompetitive antagonist of hTRPV1 with an acceptable preclinical safety profile for use in future clinical trials. SAF312, which was safe and well tolerated without causing delay in wound healing after PRK in rabbits, may be a potential therapeutic agent for ocular surface pain.
- ||| libvatrep eye drop (SAF312 eye drops) / Bausch Health
Trial completion, Surgery: Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - Jul 3, 2023
P2, N=153, Completed, Sponsor: Novartis Pharmaceuticals
SAF312, which was safe and well tolerated without causing delay in wound healing after PRK in rabbits, may be a potential therapeutic agent for ocular surface pain. Active, not recruiting --> Completed
- | libvatrep oral (SAF312) / Novartis
Journal: Topical Ocular TRPV1 Antagonist SAF312 (Libvatrep) for Postoperative Pain After Photorefractive Keratectomy. (Pubmed Central) - Mar 15, 2023
SAF312 was well tolerated and effective in reducing ocular pain post-PRK. Topical SAF312 presents a new therapeutic option for patients undergoing PRK.
- || libvatrep eye drop (SAF312 eye drops) / Bausch Health
Enrollment closed, Surgery: Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - Feb 8, 2023
P2, N=135, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Topical SAF312 presents a new therapeutic option for patients undergoing PRK. Recruiting --> Active, not recruiting
- ||| libvatrep eye drop (SAF312 eye drops) / Novartis
Clinical, PK/PD data: Monish Jain et al. @NovartisScience evaluated the safety, tolerability, pharmacokinetics, and effect on corneal sensitivity of topical ocular SAF312 in healthy participants. https://t.co/GeeYT3gnjx (Twitter) - Nov 18, 2022
- | libvatrep oral (SAF312) / Novartis
Journal: Topical Ocular TRPV1 Antagonist SAF312 (Libvatrep) Demonstrates Safety, Low Systemic Exposure, and No Anesthetic Effect in Healthy Participants. (Pubmed Central) - Nov 18, 2022
SAF312 was well tolerated, with no ocular or systemic safety concerns; had no anesthetic effect, and demonstrated rapid topical absorption with low systemic exposure. This work bridges the gap between basic research and clinical care by providing FIH data of SAF312, supporting the further investigation as a potential treatment for ocular surface pain.
- libvatrep eye drop (SAF312 eye drops) / Novartis
PO080 - Chronic Ocular Surface Pain: Patient Journey and Results From Topical Ocular SAF312 (Libvatrep) Clinical Trials () - Aug 26, 2022 - Abstract #AAO2022AAO_1779;
This work bridges the gap between basic research and clinical care by providing FIH data of SAF312, supporting the further investigation as a potential treatment for ocular surface pain. Early data show SAF312 is well tolerated and can effectively manage ocular pain in the immediate post-PRK period.
- || libvatrep eye drop (SAF312 eye drops) / Bausch Health
Trial completion date, Trial primary completion date, Surgery: Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - Feb 9, 2022
P2, N=150, Recruiting, Sponsor: Novartis Pharmaceuticals
Early data show SAF312 is well tolerated and can effectively manage ocular pain in the immediate post-PRK period. Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
- SAF312 eye drops / Novartis
[VIRTUAL] Topical ocular TRPV1 antagonist SAF312 demonstrated safety, low systemic exposure, and no anesthetic effect in healthy volunteers () - May 13, 2021 - Abstract #ARVO2021ARVO_3648;
Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023 Topical ocular SAF312 was well tolerated with no ocular or systemic safety concerns up to a supratherapeutic (8x daily) dose of the maximum concentration (2.5%); it had no anesthetic effect on the cornea and demonstrated a rapid topical absorption with low systemic exposure in healthy volunteers.
- SAF312 eye drops / Novartis
[VIRTUAL] Topical ocular TRPV1 antagonist SAF312 was well tolerated and effectively reduced pain after photorefractive keratectomy (PRK) () - May 13, 2021 - Abstract #ARVO2021ARVO_2510;
P2
Topical SAF312 was well tolerated and effective in reducing ocular pain in the immediate post-PRK period. SAF312 is currently under evaluation for postop corneal induced chronic pain (NCT04630158).
- ||| libvatrep eye drop (SAF312 eye drops) / Bausch Health
Enrollment open, Surgery: Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - Mar 18, 2021
P2, N=150, Recruiting, Sponsor: Novartis Pharmaceuticals
SAF312 is currently under evaluation for postop corneal induced chronic pain (NCT04630158). Not yet recruiting --> Recruiting
- |||| libvatrep eye drop (SAF312 eye drops) / Bausch Health
New P2 trial, Surgery: Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - Nov 15, 2020
P2, N=150, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- | libvatrep eye drop (SAF312 eye drops) / Bausch Health
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Surgery: Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery (clinicaltrials.gov) - Feb 27, 2018
P2, N=40, Completed, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Recruiting --> Completed | N=30 --> 40 | Trial completion date: Feb 2018 --> Feb 2018 | Trial primary completion date: Jan 2018 --> Jan 2018
- | libvatrep eye drop (SAF312 eye drops) / Bausch Health
Enrollment open, Trial primary completion date, Surgery: Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery (clinicaltrials.gov) - Jul 25, 2017
P2, N=30, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed | N=30 --> 40 | Trial completion date: Feb 2018 --> Feb 2018 | Trial primary completion date: Jan 2018 --> Jan 2018 Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2017 --> Dec 2017
- | libvatrep eye drop (SAF312 eye drops) / Bausch Health
New P2 trial, Surgery: Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery (clinicaltrials.gov) - Nov 9, 2016
P2, N=30, Not yet recruiting, Sponsor: Novartis Pharmaceuticals