- |||||||||| Tyrvaya (varenicline nasal spray) / Oyster Point Pharma
Journal: Varenicline nasal spray (Tyrvaya) for dry eye disease. (Pubmed Central) - Feb 8, 2022
Trial completion date: Jan 2022 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 No abstract available
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
Clinical, Journal: Association of Killer Cell Immunoglobulin-like Receptor Genotypes and Haplotypes in Dry Eye Disease Patients Treated with Restasis and Systane. (Pubmed Central) - Feb 5, 2022
The higher frequencies of KIR genotype M, AF, AJ and haplotype 2 and 8 (P = .001, P = .03, P = .004, P = .000 and P = .023, respectively) and the lower frequencies of genotype AG and haplotype 1 (P = .000 and P = .000, respectively) were observed in complete responders (CR) than those in null or partial responders (NPR) of DED patients treated by RS. The patients with KIR genotype M, AF and AJ might be of advantage to therapy with RS, which are useful for improving novel personalized precise therapy strategy in DED patients.
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
Journal: The Effect of Topical 0.05% Cyclosporine in the Prevention of Recurrence Following Pterygium Surgery. (Pubmed Central) - Jan 11, 2022
To evaluate the effect of topical cyclosporine A (CsA) (Restasis, Abbvie, Lake Bluff, IL, USA) on recurrence rates and tear metrics after pterygium excision and limbal-conjunctival autografting (LCUA) technique in patients with primary pterygium...The average increase in Schirmer I and FTBUT values was significantly higher in Group 1 than in Group 2 (p<0.05). The use of topical CsA did not demonstrate any significant improvement in the recurrence rate of pterygium following LCUA surgery.
- |||||||||| mycophenolic acid/betamethasone sodium phosphate (SURF-100) / Harrow Health
Enrollment closed, Trial completion date, Trial primary completion date, Adverse events: A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease (clinicaltrials.gov) - Jan 11, 2022
P2, N=351, Active, not recruiting,
The use of topical CsA did not demonstrate any significant improvement in the recurrence rate of pterygium following LCUA surgery. Recruiting --> Active, not recruiting | Trial completion date: Jan 2022 --> Apr 2022 | Trial primary completion date: Dec 2021 --> Mar 2022
- |||||||||| isotretinoin oral / Generic mfg.
Journal: Rosacea: An Update in Diagnosis, Classification and Management. (Pubmed Central) - Oct 30, 2021
Topical metronidazole, topical ivermectin, and topical azelaic acid are appropriate for maintenance therapy. In conclusion, the updated phenotype approach, based on presenting clinical features, is the foundation for current diagnosis, classification, and treatment of rosacea.
- |||||||||| nimesulide / Generic mfg.
Preclinical, Journal: Effects of Eye Drops Containing Hyaluronic Acid-Nimesulide Conjugates in a Benzalkonium Chloride-Induced Experimental Dry Eye Rabbit Model. (Pubmed Central) - Sep 29, 2021
Currently, anti-inflammatory agents and immunosuppressive drugs, such as cyclosporine A, have been widely used to treat this chronic condition...Compared to commercial artificial tears and Restasis, the HA-nimesulide conjugates could promote goblet cell recovery and enhance the regeneration of the corneal epithelium...In the anti-inflammatory test, the HA-nimesulide conjugates could inhibit the production of pro-inflammatory cytokines and prostaglandin E (PGE2) in the lipopolysaccharide (LPS)-stimulated Raw 264.7 cell model. In conclusion, we demonstrated that HA-nimesulide conjugates had anti-inflammatory activity, and promoted goblet cell recovery and corneal epithelium regeneration when used as topical eye drops; accordingly, the HA-nimesulide conjugates could potentially be effective for the treatment of DES.
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
Enrollment change, Trial withdrawal: Novel Use of Restasis and PROSE Devices (clinicaltrials.gov) - Aug 18, 2021
P3, N=0, Withdrawn,
In conclusion, we demonstrated that HA-nimesulide conjugates had anti-inflammatory activity, and promoted goblet cell recovery and corneal epithelium regeneration when used as topical eye drops; accordingly, the HA-nimesulide conjugates could potentially be effective for the treatment of DES. N=10 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| cyclosporin A microemulsion / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
Journal: The Role Of Nano- Ophthalmology In Treating Dry Eye Disease. (Pubmed Central) - Aug 5, 2021
Antiinflammatory agents (steroids and cyclosporine A), hormonal therapy, antibiotics, nerve growth factors, essential fatty acids are used as treatment options of DED...Nanocarrier systems show a great promise to revolutionize drug delivery in DED, offering many advantages such as site specific and sustained delivery of therapeutic agents. This review presents an overview, pathophysiology, prevalence and etiology of DED, with an emphasis on preclinical and clinical studies involving the use of nanocarrier systems in treating DED.
- |||||||||| cyclosporin A microemulsion / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
Journal: Polymeric Micelles for the Enhanced Deposition of Hydrophobic Drugs into Ocular Tissues, without Plasma Exposure. (Pubmed Central) - Jun 3, 2021
Using the ocular relevant hydrophobic drug, cyclosporine A (CsA), a non-irritant ocular penetration enhancer is showcased, which may be used for the formulation of hydrophobic actives...Meanwhile, a similar dose of Restasis 0.05% yielded lower values of 4726 ng.h/g, 4813 ng.h/g and 1729 ng.h/g for the drug corneal, conjunctival and scleral levels, respectively...The MET polymer was non-irritant up to a concentration of 4% w/v. The MET polymer is a non-irritant ocular penetration enhancer that may be used to deliver hydrophobic drugs in optically clear topical ocular formulations.
- |||||||||| Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
Journal: Loteprednol 0.25% (Eysuvis) for dry eye disease. (Pubmed Central) - May 26, 2021
The MET polymer is a non-irritant ocular penetration enhancer that may be used to deliver hydrophobic drugs in optically clear topical ocular formulations. No abstract available
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
[VIRTUAL] Cyclosporine A Dispersion without Surfactants Reveals its True Efficacy in Dry Eye Syndrome () - May 13, 2021 - Abstract #ARVO2021ARVO_2536;
Given the fact that there is no surfactant used in the eyedrop, this demonstration exhibits the true intrinsic efficacies of CsA for DES which have been inevitably veiled in oils and surfactants. We expect that this formulation would provide a pain-free solution to chronic DES patients worldwide.
- |||||||||| cyclosporin A microemulsion / Generic mfg., cyclosporine / Generic mfg.
Journal: The value and application prospect of cyclosporine A in the treatment of dry eye (Pubmed Central) - Oct 21, 2020
Meanwhile we will analyze the pros and cons and the applied prospects of ophthalmic CsA with various forms, and generalize the indications, treatment suggestions and safety of CsA used in dry eye, in order to provide references for the clinical applications. (Chin J Ophthalmol, 2020, 56:787-795).
- |||||||||| Xiidra (lifitegrast) / Novartis, Cequa (nanomicellar cyclosporine) / Sun Pharma
[VIRTUAL] The Role of Systemic Inflammation in Severe Dry Eye Disease & Meibomian Gland Dysfunction (Track 1 - Academy at Home) - Oct 14, 2020 - Abstract #AAOPT2020AAOPT_913;
The management of dry eye is labor-intensive on the part of patients, and given the severity of the presentation of DED and the many years ahead of him, aggressive treatment now is necessary. The optometrist’s role in managing dry eye extends beyond the eyes and opens up to a wealth of co-management opportunities.
- |||||||||| cyclopentolate hydrochloride / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
[VIRTUAL] Oral Vitamin C as an Adjunctive Treatment in the Management of Recurrent Corneal Erosions (Track 1 - Academy at Home) - Oct 14, 2020 - Abstract #AAOPT2020AAOPT_855;
Examination reveals a recurrent corneal erosion. Beyond typical therapeutics, treatment includes adjunctive oral vitamin C. Case History 54 y/o AAFCC: itching/tearing OD x 3 daysPOHx: corneal abrasion OD (first noted 2016), multiple subsequent recurrent corneal erosions (RCEs) OD, dry eye syndrome (DES) OU, blepharitis OUMeds: Restasis, not used for past month Pertinent Findings VA sc: 20/20-2 OD, OSSlit lamp:OD: 2x3mm inferior-nasal RCE, (-)infiltrate, (-)cells/flare, (-)FBOS: 1+ inferior SPKOU: trace scurfAdditional:External photos at presentation, during resolution Differential Diagnosis Leading: RCEOthers: HSV epithelial keratitis, exposure keratopathy, neurotrophic keratitis, DES Diagnosis and Discussion RCE:Highest prevalence: ages 30-40Highest occurrence in patients with DES, diabetes, blepharitis, ocular rosaceaSigns/symptoms:Sudden sharp, unilateral eye pain immediately upon awakening with associated redness, tearing, photophobia, blurred vision (depending on size/location)Etiology:Mechanical trauma of superficial cornea in predisposed eyesPredisposing conditions: previous corneal abrasion, epithelial basement membrane dystrophy (EBMD), corneal dystrophies/degenerations, prior ocular surgeryMost common cause: prior abrading injury (45-64%)Second most common cause: EBMD (19-29%) Treatment, Management Traditional treatment (tx):Prophylactic topical antibiotic, preservative-free artificial tears/ointment, topical cycloplegic for pain control, hypertonic saline solution, bandage contact lens (BCL)If conservative therapy fails: diamond burr polishing, anterior stromal puncture, excimer laser phototherapeutic keratectomyNewer established tx options:Oral matrix metalloproteinase inhibitors, autologous serum tears, amniotic membranesOur tx plan:BCL, Polytrim qid OD, Refresh Celluvisc PFATs q1h OD, cyclopentolate bid OD, doxycycline 50 mg bid PO, vitamin C taken daily according to package instructions, Muro drops qid OD added at 1-day follow-upUnique tx in this case: oral vitamin C supplementationTaken in tablet or powder (e.g. Emergen-C) formVitamin C shown to have therapeutic value in minimizing corneal opacity secondary to infectious keratitis, and potential efficacy in promoting/accelerating corneal wound healing in cases of UV irradiation, alkali burns, neovascularization, and inflammation.Mechanism: promotion of collagen synthesis, extracellular matrix (ECM) organization, and increased stemness of epithelial stem/progenitor cellsAscorbic acid treatment shown to result in significantly higher synthesis of ECM components of corneal epithelial basement membrane (collagen IV, laminin, fibronectin) and stroma (collagen I), with consequent upregulation of stemness marker (p63 and SOX2) expression. Conclusion Given the multifaceted approach to treating RCE, it is important to provide detailed medication list for patient compliance.Although studies have yet to demonstrate the efficacy of systemic vitamin C in preventing/reducing scarring due to RCEs specifically, it is a promising adjunctive therapy with easy implementation and excellent safety profile.
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
[VIRTUAL] Troubleshooting Mid-Day Fog with Scleral Contact Lenses: Battling the Sjogren’s Marathon (Track 1 - Academy at Home) - Oct 14, 2020 - Abstract #AAOPT2020AAOPT_673;
Although not a contraindication to lens wear, fogging studies report 25% patient drop-out rates due to visual dissatisfaction and inconvenience factors3. Case History 47yo Hispanic femaleChief complaint: Intermittent blurred vision OS > OD with scleral lenses after 3 to 4 hours of wear even when applying lenses with one drop of Celluvisc added to the salineOcular history:-Sjogren’s Syndrome x 2009-History of filamentary keratitis and severe punctate epithelial erosion OU x 2014Medical history: Rheumatoid Arthritis x 2009Medications: Actemra®Other salient information:-Compliant with Restasis BID OU x 2014-Average lens wear time was 16 to 18 hours per day due to symptoms of dry eyes-Removed and reapplied lenses 4 times per day for relief of fogging-Patient reported stinging with Addipak and LacriPure non-preserved saline Pertinent Findings -BCVA: 20/20-2 OD, OS-Cornea: clear, intact, (-) superficial punctate keratitis OU, (-) filaments OU-Cloudy, white tear reservoir with scattered opaque debris OU between lenses and cornea after 3 hours of wear-Right Eye Scleral Lens Fit: 175um central clearance; midperiphery clearance: 115um nasal, 250um temporal, 135um superior, 225 inferior; adequate limbal clearance 360, good scleral alignment-Left Eye Scleral Lens Fit: 325um central clearance; midperiphery clearance: 150um nasal, 400um temporal, 300um superior, 325um inferior, adequate limbal clearance 360, impingement at 2 & 7 o’clock Differential Diagnosis Primary/Leading: Debris accumulation in tear reservoir leading to symptoms of blurred visionSecondary:-Stromal or epithelial corneal edema: lens reapplication will not resolve symptoms of fogging-Poor F1 surface wettability: appears similar to oil on water compared to a milk-like appearance in tear reservoir fogging-Poor lens hygiene or care: lens deposits, makeup debris, or scratches may cause a foggy appearance Diagnosis and Discussion Mid-day fog occurs at increased frequency in individuals diagnosed with keratitis sicca and other inflammatory conditions2This complication is usually caused by buildup of particulate matter in the tear reservoir between the cornea and scleral contact lens immediately after lens application or after several hours of lens wear1Indications for debris build-up:-Evaluate for excessive edge lift causing lens-to-eyelid interaction and possible giant papillary conjunctivitis.-Utilize NaFl dye to evaluate tear exchange and dye uptake under the lens-Examine for excessive lens movement. Treatment, Management -Reduced central clearance to approximately 100um after 4 hours of settling and steepened peripheral curves for a tighter scleral alignment-Switched saline solution to Nutrifill instead of Addipak-Patient reported symptoms of fogging abated and reported reapplication of lenses to only one time per day Conclusion -Avoid excessive central clearance and flat fitting scleral landing zones-Consider high-viscosity saline solutions with higher pH levels greater or equal to pH = 7.4-In this case, visual acuity remained stable. However, for full-time scleral lens wearers, the inconvenience caused by reapplying lenses and the associated cost of lens care solution may increase the drop-out rate of scleral lens wearers who experience mid-day fog-Continue co-management with her rheumatologist and dry eye specialist
- |||||||||| Restasis X (ciclosporin ophthalmic new formulation) / AbbVie, Xiidra (lifitegrast) / Novartis
[VIRTUAL] When Artifical Tears Won't Do the Trick (Track 1 - Academy at Home) - Oct 14, 2020 - Abstract #AAOPT2020AAOPT_650;
This patient is diagnosed with depression, another reason why neuropathic pain was considered. All in all, this case was unique because it displayed how a patient was systematically treated for dry eye and even then, symptoms still persisted.
- |||||||||| Xiidra (lifitegrast) / Novartis
[VIRTUAL] Thinking Outside the Dry Eye Box (Track 1 - Academy at Home) - Oct 14, 2020 - Abstract #AAOPT2020AAOPT_431;
At that visit the bandage contact lens was removed OS and an additional amniotic membrane and contact lens were placed ODPatient instructed to follow-up in 1 week for anterior segment assessment. Future treatment options include maintenance amniotic membranes and/or scleral lenses Conclusion DES is a multifactorial condition that has many different treatment optionsAmniotic membranes are a newer treatment for various ocular surface conditions that have shown tremendous promise by improving both the signs and symptoms of ocular surface diseaseAlthough the patient’s symptoms only improved mildly, there was improvement in the grade of corneal SPK and the patient’s best corrected visual acuity
- |||||||||| loteprednol etabonate / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
Enrollment open, Monotherapy: Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax (clinicaltrials.gov) - Oct 4, 2020
P4, N=30, Recruiting,
Future treatment options include maintenance amniotic membranes and/or scleral lenses Conclusion DES is a multifactorial condition that has many different treatment optionsAmniotic membranes are a newer treatment for various ocular surface conditions that have shown tremendous promise by improving both the signs and symptoms of ocular surface diseaseAlthough the patient’s symptoms only improved mildly, there was improvement in the grade of corneal SPK and the patient’s best corrected visual acuity Not yet recruiting --> Recruiting
- |||||||||| [VIRTUAL] A case report of ophthalmic sarcoidosis (Abstract Channel) - Sep 28, 2020 - Abstract #EURETINA2020EURETINA_1388;
Clinically, was found with interstitial uveitis and therapy with Methylprednisolone systematically and eye drops Dexamethasone were initiated. Many autoimmune diseases such as Sarcoidosis, are more likely to present with initial symptoms from the eyes.
- |||||||||| Cequa (nanomicellar cyclosporine) / Sun Pharma, cyclosporine / Generic mfg.
Journal: Ocular Distribution of Cyclosporine Following Topical Administration of OTX-101 in New Zealand White Rabbits. (Pubmed Central) - Jun 19, 2020
In the single-dose phase, rabbits received a single instillation of OTX-101 0.05% or CsA ophthalmic emulsion 0.05% (Restasis; Allergan, Irvine, CA) as a comparator. OTX-101 topical ophthalmic instillation resulted in extensive distribution of CsA in ocular tissues, particularly in target tissues for DED (cornea and conjunctiva), while systemic exposure was negligible.
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