- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
Journal: Cornea Classic: "Grading of Corneal and Conjunctival Staining in the Context of Other Dry Eye Tests," Bron, Evans, and Smith, 2003. (Pubmed Central) - Jul 1, 2024 Although there has been a recent explosion of research in the field since 2002 with the approval of the first prescription topical treatment (Restasis, Allergan Inc, Irvine CA), dry eye lags behind other ophthalmic conditions where clinically meaningful outcome measures are closely tied with the metrics by which their therapeutics are evaluated...The landmark article by Bron, Evans, and Smith published in Cornea in 2003 provides excellent guidance to clinicians to highlight and quantify ocular surface parameters in patients with dry eye. Validation studies correlating conjunctival or corneal staining with tangible quality-of-life parameters and metrics to measure those are needed to verify ocular surface staining as a clinically meaningful dry eye outcome to be used in clinical practice and clinical trials.
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
Clinical, P2 data: Improved Signs and Symptoms of Dry Eye Disease for Restasis (Pubmed Central) - Jun 3, 2024 SAHARA showed 6-month superiority of LHT to CsA in clinical signs and non-inferiority in symptom scores. This extension shows that patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy.
- |||||||||| ciclosporine/trehalose (HUC2-007) / Huons
Trial completion, Head-to-Head: HU007 in Patients with Dry Eye Syndrome (clinicaltrials.gov) - May 12, 2024 P3, N=328, Completed, This extension shows that patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy. Recruiting --> Completed
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
Journal: A Randomized, Controlled Trial Comparing Tearcare (Pubmed Central) - Mar 25, 2024 Not yet recruiting --> Completed | Trial completion date: Aug 2022 --> Sep 2023 | Trial primary completion date: Jul 2022 --> Jul 2023 No abstract available
- |||||||||| NovaTears (perfluorohexyloctane) / Novaliq, Bausch Health, AFT Pharma
Early Adoption and Utilization of Perfluorohexyloctane for Treatment of Dry Eye Disease () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_239; Early adopters of PHO were slightly younger and had a higher proportion of patients with a DED diagnosis compared to other agents. PHO tended to have more treatment-experienced patients in the 12 months prior to initiation, potentially highlighting a subgroup of the patient population who were waiting for a new treatment option for evaporative DED in addition to inflammation.
- |||||||||| cyclosporine A (SCAI-001) / SCAI Therap
Trial completion: Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis (clinicaltrials.gov) - Feb 5, 2024 P2, N=116, Completed, PHO tended to have more treatment-experienced patients in the 12 months prior to initiation, potentially highlighting a subgroup of the patient population who were waiting for a new treatment option for evaporative DED in addition to inflammation. Active, not recruiting --> Completed
- |||||||||| doxycycline / Generic mfg., isotretinoin / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
Review, Journal: Treatment of ocular rosacea: a systematic review. (Pubmed Central) - Jan 20, 2024 Active, not recruiting --> Completed Treatment options for ocular rosacea include lid hygiene, topical and oral antibiotics, cyclosporine ophthalmic emulsion, oral vitamin
- |||||||||| Xiidra (lifitegrast) / Novartis
Journal: Dry Eye Disease: Focus on Prescription Therapy. (Pubmed Central) - May 30, 2023 Pharmacists have an opportunity to provide patient education regarding lifestyle modifications to mitigate DED and provide counseling on available products. Emerging therapies may provide advances in DED treatment.
- |||||||||| ciclosporine/trehalose (HUC2-007) / Huons
Enrollment open, Head-to-Head: HU007 in Patients with Dry Eye Syndrome (clinicaltrials.gov) - Mar 31, 2023 P3, N=328, Recruiting, CsA released more rapidly from CsA-Lips in comparison with self-made emulsion and Restasis Not yet recruiting --> Recruiting
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients (clinicaltrials.gov) - Jun 8, 2022 P4, N=438, Completed, Oyster Point Pharma, Inc sponsored the Phase 3 OC-01 (varenicine solution) clinical study from which analysis data are obtained. Not yet recruiting --> Completed | Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Sep 2020 --> Jul 2021
- |||||||||| cyclosporine ophthalmic emulsion / Generic mfg.
Journal: First Generic Cyclosporine Drops for Dry Eye. (Pubmed Central) - Jun 4, 2022 Not yet recruiting --> Completed | Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Sep 2020 --> Jul 2021 The Food and Drug Administration has approved the first generic version of Restasis, the cyclosporine ophthalmic emulsion eye drops used to treat dry eye.The generic version is expected to provide cost savings for patients, especially those whose insurance does not cover Restasis.
- |||||||||| loteprednol etabonate / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
Trial completion, Trial completion date, Trial primary completion date, Monotherapy: Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax (clinicaltrials.gov) - May 11, 2022 P4, N=30, Completed, The Food and Drug Administration has approved the first generic version of Restasis, the cyclosporine ophthalmic emulsion eye drops used to treat dry eye.The generic version is expected to provide cost savings for patients, especially those whose insurance does not cover Restasis. Recruiting --> Completed | Trial completion date: Oct 2021 --> Feb 2022 | Trial primary completion date: Jun 2021 --> Feb 2022
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