Patient Experience Study Evaluating The Effect of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and QOL in Patients With Mild to Moderate DED and High Digital Device Use

Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) in adult participants with dry eye symptoms and who are high digital device users.
NGE-UD is an over-the-counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of NGE-UD on Day 1 for the acute phase of the study, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Around 50 adult participants will be enrolled at one site in the United States.
There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site as per standard of care.

Start Date17 Jun 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT01368198 / CompletedNot Applicable

The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.

Start Date01 Mar 2011

Sponsor / Collaborator

Alcon Research Ltd.

NCT00698945 / CompletedPhase 4

Randomized, Investigator Masked Comparison of Istalol™ 0.5% QD (Timolol Maleate/Sorbitol Complex, ISTA Pharmaceutical) to Brimonidine Tartrate 0.1% BID as Adjunctive Therapy to Latanoprost 0.005% in Adults With Ocular Hypertension (OHT) or Open-Angle Glaucoma (OAG)

To assess the additional benefit of common adjunctive classes on the diurnal IOP curve in patients assessed as needing additional treatment to reach target intraocular pressure (IOP). To demonstrate superiority of IOP control with Istalol 0.5% QD compared to Brimonidine Tartrate 0.2% BID as adjunctive therapy in adults with uncontrolled IOP's (determined by P.I. based on target pressures) currently treated with Latanoprost 0.05% in the study eye(s).

Start Date01 Jun 2008

Sponsor / Collaborator

Nikkei BP Consulting, Inc.

100 Clinical Results associated with Carboxymethylcellulose Sodium/Glycerol

100 Translational Medicine associated with Carboxymethylcellulose Sodium/Glycerol

100 Patents (Medical) associated with Carboxymethylcellulose Sodium/Glycerol

Literatures (Medical) associated with Carboxymethylcellulose Sodium/Glycerol

01 Jan 2021·Ophthalmologica

Evaluation of Carboxymethylcellulose Sodium plus Glycerin (Optive®) in Ocular Discomfort after Anti-Vascular Endothelial Growth Factor Intravitreal Injection Therapy: A Prospective Study

Article

Author: Delacour, Celine ; Souied, Eric H ; Semoun, Oudy ; Capuano, Vittorio ; Miere, Alexandra ; Jung, Camille ; Karcenty, Mickael ; Gueunoun, Sacha

Objective: The aim of this study was to evaluate the efficacy of a mix of carboxymethylcellulose and glycerin (Optive®) after intravitreal injection therapy (IVT) with anti-vascular endothelial growth factor for reducing ocular discomfort in patients. Methods: We prospectively included patients who were naïve to any IVT. No artificial tear treatment was prescribed after the first IVT. After the second IVT, all patients instilled 3 drops per day of Optive® for 3 days. Every patient answered a questionnaire concerning the ocular discomfort at 72 h after both IVTs and a questionnaire about tolerance to treatment after the second IVT. Results: We included 45 patients (mean age 72.3 years [range 23–94], 25 females); 14 (34.1%) reported a feeling of grittiness after the first IVT but not after the second (p = 0.01); 12 (29.3%) complained of global discomfort after the first IVT but not after the second (p = 0.14); and 11 (26.8%) reported a watery eye after the first IVT but not after the second (p = 0.21); 37/45 (82%) patients felt ocular discomfort after IVT. Conclusion: Most patients felt ocular discomfort after IVT. Instillation of Optive® significantly alleviated the feeling of grittiness for more than half of the patients.

01 Aug 2019·Regulatory Toxicology and PharmacologyQ4 · MEDICINE

Medical devices biocompatibility assessment on HCE: Evidences of delayed cytotoxicity of preserved compared to preservative free eye drops

Q4 · MEDICINE

Article

Author: Ceriotti, Laura ; Meloni, Marisa ; Balzaretti, Silvia

A multiple endpoint analysis (MEA) approach on human reconstructed corneal epithelium (HCE) model has been applied to assess the biocompatibility (cytotoxicity and irritation potential) of medical devices (MD): ophthalmology literature clearly shows the need to better assess these products to exclude any potential chronic damage to the ocular surface. Preserved eye drops (Artelac Multidose, Optive multidose and Artelac Rebalance Multidose) and the same without preservative (Artelac Edo, Optive Unidose, Artelac Rebalance Unidose) and Thealoz Duo were tested after acute (24 h + 16 h post incubation) and repeated (2 applications/day for 72 h) exposure using BAK 0.01% as positive control on HCE. Cellular viability, trans-epithelial electrical resistance measurements, LDH release and occludin gene expression were evaluated for each product to discriminate the potential toxicity of preservatives. The BAK 0.01% toxicity on HCE was confirmed following both exposures. The analysis of the same parameters reveals that the 72 h exposure was suitable to identify toxicity and damages to the ocular surface even for 'soft' preserved MD. The results confirm the reliability, sensitivity and predictivity of the MEA on HCE in detecting subclinical signs of cellular toxicity: 'soft' preservatives resulted toxics suggesting that delayed toxicity should be integral part of the biocompatibility assessment of ophthalmic formulations intended for long-term use.

04 May 2018·Current Eye ResearchQ4 · MEDICINE

The Effect of Optive and Optive Advanced Artificial Tears on the Healthy Tear Film

Q4 · MEDICINE

Article

Author: Markoulli, Maria ; Tan, Jacqueline ; Sobbizadeh, Amanda ; Briggs, Nancy ; Coroneo, Minas

PURPOSETo evaluate the impact of Optive (Allergan, Irvine, CA) and Optive Advanced (Allergan, Irvine, CA) on tear film stability and quality during a one-hour observation period when compared to saline (Pfizer, Perth, WA).METHODSThis was a double-masked, cross-over study. Twenty participants attended three visits, randomly receiving either Optive, Optive Advanced or saline. Oculus Keratograph 5M (Oculus, Arlington, WA, USA), non-invasive keratograph break-up time (NIKBUT), Lipiview (TearScience Inc, Morrisville, NC, USA), lipid layer thickness (LLT) and comfort were measured prior to and 5, 15 and 60 min after drop instillation.RESULTSOptive Advanced demonstrated a significant increase in LLT between baseline (57.5 ± 12.3 nm) and both 5 min (67.5 ± 18.8 nm, p = 0.04) and 15 min (68.9 ± 17.3 nm, p = 0.04) but not 60 min (61.6 ± 14.3 nm, p = 0.47). Optive and saline were not different between timepoints for LLT (p > 0.05). There was no difference between timepoints for any of the drops for NIKBUT (p = 0.75). Comfort was significantly better at 5 min compared to baseline for Optive (8.3 ± 1.2 and 7.3 ± 1.4, respectively, p = 0.03) but not different for Optive Advance or saline (p > 0.05).CONCLUSIONSOptive Advanced increased LLT for 15 min following instillation, returning to baseline within one hour. This did not however, translate into an improvement in tear film stability over this time period. Only Optive demonstrated an improvement in comfort.

100 Deals associated with Carboxymethylcellulose Sodium/Glycerol

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Indication	Country/Location	Organization	Date
Dry Eye Syndromes	-	Allergan, Inc.	-

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