Miebo (Perfluorohexyloctane) is a novel, non-aqueous, single entity, preservative free, ophthalmic drop. This drop was recently approved by the Food and Drug Administration (FDA) for the treatment of Meibomian Gland Disease (MGD).
All published data on Miebo has been done in non-contact lens wearers. As contact lens dropout rates seem to be an ongoing problem for practitioners, we are performing this study utilizing this novel new drug with contact lens patients to determine if the drops assist comfort in typical soft contact lens wearing patients. If the study determines that Miebo assists in the overall comfort of contact lens patients this could be a possible way to help keep patients in their contact lenses longer.

Start Date21 Sep 2023

Sponsor / Collaborator

The Gordon Schanzlin New Vision Institute, Inc.

NCT05624320

/ WithdrawnPhase 4

Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes

AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. There are many other applications AGN-190584 could be used for and further studies will show the effectiveness for each.

Start Date01 Dec 2022

Sponsor / Collaborator

The Gordon Schanzlin New Vision Institute, Inc.

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100 Clinical Results associated with The Gordon Schanzlin New Vision Institute, Inc.

0 Patents (Medical) associated with The Gordon Schanzlin New Vision Institute, Inc.

Literatures (Medical) associated with The Gordon Schanzlin New Vision Institute, Inc.

01 Feb 2024·Ophthalmology and Therapy

Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO)

Article

Author: Schanzlin, David ; Mantelli, Flavio ; Massaro-Giordano, Mina ; Goisis, Giovanni ; Pasedis, Georgea ; Berdy, Gregg ; Hamrah, Pedram ; Holland, Edward

INTRODUCTIONCenegermin is approved for treatment of neurotrophic keratopathy (NK) and has been studied in patients with stage 2 or 3 NK. This study evaluated the efficacy and safety of cenegermin in adults with stage 1 NK.METHODSThis was a phase IV, multicenter, prospective, open-label, uncontrolled trial. Adults with stage 1 NK (Mackie criteria) and decreased corneal sensitivity (≤ 4 cm) received 1 drop of cenegermin 20 mcg/ml in the affected eye(s) 6 times/day for 8 weeks with a 24-week follow-up.RESULTSOf 37 patients, corneal epithelial healing was observed in 84.8% (95% confidence interval [CI] 68.1-94.9%; P < 0.001) at week 8; 95.2% (95% CI 76.2-99.9%; P < 0.001) of those patients remained healed at the end of the 24-week follow-up (week 32). At week 8, 91.2% (95% CI 76.3-98.1%; P < 0.001) of patients experienced improved corneal sensitivity; this improvement was observed in 82.1% (95% CI 63.1-93.9%; P < 0.001) of patients at week 32. Mean best-corrected distance visual acuity change from baseline at week 8 was - 0.10 logMAR (standard deviation [SD], 0.15; 95% CI - 0.16 to - 0.05; P < 0.001) and at week 32 was - 0.05 logMAR (SD, 0.16; 95% CI - 0.11 to 0.01; P = 0.122). At weeks 8 and 32, 15.2% (95% CI 5.1-31.9%; P < 0.001) and 10.7% (95% CI 2.3-28.2%; P < 0.001) of patients, respectively, had a 15-letter gain from baseline. At least one adverse event (AE) was reported by 73.0% and 45.7% of patients during the treatment and follow-up periods, respectively. The most common treatment-related, treatment-emergent AEs were eye pain (37.8%), blurred vision (10.8%), and eyelid pain (8.1%); these were mostly mild or moderate and were only reported during the treatment period.CONCLUSIONSThese results support the potential use of cenegermin for treating patients with stage 1 NK, and future confirmatory studies would be beneficial to elaborate on these findings.TRIAL REGISTRATIONDEFENDO; NCT04485546.

Journal of Cataract & Refractive Surgery

Effectiveness and safety of a thermo-mechanical action device versus thermal pulsation device in the treatment of meibomian gland dysfunction

Article

Author: Berdy, Gregg J. ; Verachtert, Anthony ; Parkhurst, Gregory D. ; Echegoyen, Julio ; Sadri, Ehsan ; Klein, Ifat ; Agmon, Yael G.

Purpose:To evaluate the safety and effectiveness of thermo-mechanical action (Tixel C, Novoxel) compared with thermal pulsation (LipiFlow, Johnson & Johnson) in meibomian gland dysfunction (MGD).Setting:Private clinics and University clinic, USADesign:Prospective, randomized (1:1), evaluator-masked, multicenter studyMethods:Subjects with Ocular Surface Disease Index (OSDI) between 23 and 79, fluorescein tear break-up time (TBUT) <10 s and Meibomian Gland Score (MGS) ≤12 in each eye received bilateral thermo-mechanical action (TMA) or thermal pulsation (TP). The treatment consisted of three sessions, two weeks apart, for TMA and one session for TP. TBUT, OSDI, MGS, and corneal and conjunctival staining (CCS) were assessed at baseline and at Weeks 4 and 12 post-last treatment session. The primary effectiveness endpoint was change in TBUT at Week 4.Results:Among the 106 treated subjects (N=53 per group), TBUT improved significantly (p<0.001) by 3.0±3.2 and 3.1±4.3 seconds after TMA and 2.7±2.7 and 3.3±3.6 seconds after TP, at Week 4 and Week 12, respectively. The change in TBUT for TMA was non-inferior to TP (linear mixed-effects model, p<0.001). OSDI, MGS and CCS significantly improved from baseline (p<0.001), with no significant between-group differences (p>0.05). OSDI improved by 26.4±21.1 and 28.6±22.4 after TMA and 18.8±21.0 and 21.9±18.5 after TP, at Week 4 and Week 12, respectively. No device-related adverse event occurred in either group.Conclusion:TMA safely and effectively improved clinical signs and symptoms of evaporative dry eye disease associated with MGD over a 12-week period, comparable to TP.

Clinical Ophthalmology

A Randomized, Controlled Trial Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA) [Response To Letter]

Article

Author: Saenz, Bobby ; Perez, Victor L ; Chester, Thomas ; Ayres, Brandon D ; Ehegoyen, Julio ; Loh, Jennifer ; Bloomenstein, Marc R ; Kannarr, Shane R ; Rodriguez, Tomasita C ; Dickerson, Jaime E

100 Deals associated with The Gordon Schanzlin New Vision Institute, Inc.

100 Translational Medicine associated with The Gordon Schanzlin New Vision Institute, Inc.

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