Abstract
Purpose To compare the consecutive therapeutic effects of 0.05% emulsion and nanoemulsion cyclosporine (CsA) in dry eye patients after short-term treatment with unpreserved 0.1% fluorometholone (FML). Methods A prospective, randomized, and double-blinded study of dry eye patients was conducted in a single center. Patients were assigned to the nanoemulsion CsA (group 1) and emulsion CsA (group 2) groups. To relieve discomfort, unpreserved 0.1% FML was used in both groups for 4 weeks and then changed to 0.05% CsA for the next 8 weeks. Symptom assessment in dry eye (SANDE) score, tear secretion, tear film breakup time (TBUT), corneal staining score (CSS), meibomian gland dysfunction (MGD) grade, and meibomian gland (MG) expression were evaluated at baseline and at 4 and 12 weeks after treatment. Results Twenty-four patients completed the treatment (9 and 15 patients in groups 1 and 2); in both the groups, SANDE score, TBUT, MGD grade, and MG expression were significantly improved after treatment with unpreserved 0.1% FML (each p < 0.005), and the therapeutic effects were enhanced with changes in nanoemulsion or emulsion CsA compared with baseline (each p < 0.001). TBUT and CSS after treatment in group 1 were significantly improved compared to those in group 2 (p=0.003 and 0.020, respectively). Conclusion Consecutive therapeutic effects of nanoemulsion or emulsion CsA after short-term treatment with unpreserved FML were excellent in patients with dry eyes. Topical nanoemulsion CsA showed better improvement in TBUT and OSS than CsA. This trial is registered with KCT0006070.
Highlights
According to the TFOS DEWS II, dry eye disease (DED) is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film accompanied by ocular symptoms in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles [1,2,3]
Fifteen patients no longer wanted to participate in this trial, nine patients were unable to be contacted, and two patients were excluded from the clinical trial because of acute viral conjunctivitis (Figure 1). e mean age of patients in groups 1 and 2 was 58.6 ± 11.4 and 62.1 ± 6.4 years, respectively (p 0.279). e best-corrected visual acuity (BCVA), intraocular pressure, meibomian gland dysfunction (MGD) grade, and meibomian gland (MG) expression at baseline were not significantly different between the two groups (p > 0.05) (Table 1)
In groups 1 and 2, Symptom assessment in dry eye (SANDE) score, tear film breakup time (TBUT), MGD grade, and MG expression were significantly improved after treatment with unpreserved 0.1% FML for the initial 4 weeks and intraocular pressure did not increase significantly (p 0.873/0.723, Table 2)
Summary
According to the TFOS DEWS II, dry eye disease (DED) is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film accompanied by ocular symptoms in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles [1,2,3]. Inhibition of IL-2 formation blocks T-cell proliferation and suppresses T-cell-mediated immune responses [6, 7] In this manner, topical CsA is known to reduce the activated lymphocytes of the conjunctiva, inhibit the factors associated with inflammation and cell death, and increase the density of goblet cells in the conjunctiva; it is used as a therapeutic agent for dry eye patients to improve tear production [5, 6]. Us, we compared the consecutive therapeutic effects of 0.05% nanoemulsion and emulsion CsA after common short-term treatment with unpreserved fluorometholone (FML) in DED patients. Differences were considered statistically significant at p < 0.05
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