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Topical fluorometholone treatment for ocular dryness in patients with Sjögren syndrome: a randomized clinical trial in China.

Lin T, Gong L - Medicine (Baltimore) (2015)

Bottom Line: After 8 weeks of therapy, the conjunctival goblet cell density was significantly higher in both the groups (P < 0.001 for both) compared with the baseline values.Conjunctival congestion was reduced in both the groups throughout the study, and the severity in the FML group was significantly less at week 4 compared with that in the CsA group (P = 0.035).Treatment using topical 0.1% FML provided faster improvement in the symptoms of ocular dryness in SS patients compared with topical 0.5% CsA.

View Article: PubMed Central - PubMed

Affiliation: From the Department of Ophthalmology (TL, LG), Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.

ABSTRACT
The purpose of the study was to evaluate the efficacy of an ophthalmic solution containing 0.1% fluorometholone (FML) and 0.1% sodium hyaluronate (HA) for the treatment of ocular dryness in Sjögren syndrome (SS) patients.Forty SS patients were randomly assigned to the FML or cyclosporin A (CsA) treatment groups. The FML group was treated with 0.1% FML and 0.1% HA, and the CsA group was treated with 0.5% CsA and 0.1% HA. Primary outcomes were corneal fluorescein staining (CFS), the Ocular Surface Disease Index (OSDI) score, conjunctival goblet cell density, and the severity of conjunctival congestion. Patients were also evaluated based on tear film breakup time (TFBUT) and the Schirmer test. After 8 weeks of treatment, the mean CFS scores were significantly lower in both the groups, compared with the baseline values, and the CFS score of the FML group at week 2 was significantly lower than that of the CsA group (P = 0.042). The OSDI scores improved significantly in both the groups throughout the study, and the OSDI score in the FML group at week 4 was significantly lower than that of the CsA group (P = 0.042). After 8 weeks of therapy, the conjunctival goblet cell density was significantly higher in both the groups (P < 0.001 for both) compared with the baseline values. Conjunctival congestion was reduced in both the groups throughout the study, and the severity in the FML group was significantly less at week 4 compared with that in the CsA group (P = 0.035). The TFBUT in the FML group at week 8 was significantly longer than in the CsA group (P = 0.04). Treatment using topical 0.1% FML provided faster improvement in the symptoms of ocular dryness in SS patients compared with topical 0.5% CsA.

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Related in: MedlinePlus

Number of conjunctival goblet cells in the CsA and FML patients at baseline and after 8 weeks of treatment. (A) Conjunctival goblet cells were stained with periodic acid-Schiff (PAS) stain. The arrow indicates a PAS-positive cell (bar = 100 μm). a: Conjunctival goblet cells in the FML group before treatment. b: Conjunctival goblet cells after 8 weeks of FML treatment. c: Conjunctival goblet cells in the CsA group before treatment. d: Conjunctival goblet cells after 8 weeks of CsA treatment. (B) Density of PAS-positive conjunctival goblet cells. +Significantly different from the baseline value (FML group: P < 0.001 at weeks 4 and 8; CsA group: P < 0.001 at weeks 4 and 8). No significant intergroup difference was observed at any time point (P = 0.653 at week 4; P = 0.934 at week 8). CsA = cyclosporine, FML = fluorometholone, W = week.
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Figure 5: Number of conjunctival goblet cells in the CsA and FML patients at baseline and after 8 weeks of treatment. (A) Conjunctival goblet cells were stained with periodic acid-Schiff (PAS) stain. The arrow indicates a PAS-positive cell (bar = 100 μm). a: Conjunctival goblet cells in the FML group before treatment. b: Conjunctival goblet cells after 8 weeks of FML treatment. c: Conjunctival goblet cells in the CsA group before treatment. d: Conjunctival goblet cells after 8 weeks of CsA treatment. (B) Density of PAS-positive conjunctival goblet cells. +Significantly different from the baseline value (FML group: P < 0.001 at weeks 4 and 8; CsA group: P < 0.001 at weeks 4 and 8). No significant intergroup difference was observed at any time point (P = 0.653 at week 4; P = 0.934 at week 8). CsA = cyclosporine, FML = fluorometholone, W = week.

Mentions: The cytology examinations revealed that a significantly higher number of PAS-positive cells were present in both the treatment groups at weeks 4 and 8, compared with the baseline values (Figure 5A). After 8 weeks of treatment, the conjunctival goblet cell density was also significantly higher in both the groups, increasing by 41.00 ± 37.79 cells/mm2 in the FML group (P < 0.001) and 39.4 ± 34 cells/mm2 in the CsA group (P < 0.001), compared with the baseline values (Figure 5B). However, no significant intergroup difference in conjunctival goblet cell density was observed at week 4 (P = 0.653) or week 8 (P = 0.934). The severity of conjunctival congestion was reduced in both the groups throughout the study period, compared with that at baseline (Table 2). Although no significant intergroup difference in the severity of conjunctival congestion was observed at weeks 2 and 8, the conjunctival congestion was significantly less severe in the FML group at week 4 (P = 0.035), compared with that in the CsA group, indicating that the beneficial effect of the FML treatment was manifested more quickly at the conjunctiva than that of the CsA treatment.


Topical fluorometholone treatment for ocular dryness in patients with Sjögren syndrome: a randomized clinical trial in China.

Lin T, Gong L - Medicine (Baltimore) (2015)

Number of conjunctival goblet cells in the CsA and FML patients at baseline and after 8 weeks of treatment. (A) Conjunctival goblet cells were stained with periodic acid-Schiff (PAS) stain. The arrow indicates a PAS-positive cell (bar = 100 μm). a: Conjunctival goblet cells in the FML group before treatment. b: Conjunctival goblet cells after 8 weeks of FML treatment. c: Conjunctival goblet cells in the CsA group before treatment. d: Conjunctival goblet cells after 8 weeks of CsA treatment. (B) Density of PAS-positive conjunctival goblet cells. +Significantly different from the baseline value (FML group: P < 0.001 at weeks 4 and 8; CsA group: P < 0.001 at weeks 4 and 8). No significant intergroup difference was observed at any time point (P = 0.653 at week 4; P = 0.934 at week 8). CsA = cyclosporine, FML = fluorometholone, W = week.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4554178&req=5

Figure 5: Number of conjunctival goblet cells in the CsA and FML patients at baseline and after 8 weeks of treatment. (A) Conjunctival goblet cells were stained with periodic acid-Schiff (PAS) stain. The arrow indicates a PAS-positive cell (bar = 100 μm). a: Conjunctival goblet cells in the FML group before treatment. b: Conjunctival goblet cells after 8 weeks of FML treatment. c: Conjunctival goblet cells in the CsA group before treatment. d: Conjunctival goblet cells after 8 weeks of CsA treatment. (B) Density of PAS-positive conjunctival goblet cells. +Significantly different from the baseline value (FML group: P < 0.001 at weeks 4 and 8; CsA group: P < 0.001 at weeks 4 and 8). No significant intergroup difference was observed at any time point (P = 0.653 at week 4; P = 0.934 at week 8). CsA = cyclosporine, FML = fluorometholone, W = week.
Mentions: The cytology examinations revealed that a significantly higher number of PAS-positive cells were present in both the treatment groups at weeks 4 and 8, compared with the baseline values (Figure 5A). After 8 weeks of treatment, the conjunctival goblet cell density was also significantly higher in both the groups, increasing by 41.00 ± 37.79 cells/mm2 in the FML group (P < 0.001) and 39.4 ± 34 cells/mm2 in the CsA group (P < 0.001), compared with the baseline values (Figure 5B). However, no significant intergroup difference in conjunctival goblet cell density was observed at week 4 (P = 0.653) or week 8 (P = 0.934). The severity of conjunctival congestion was reduced in both the groups throughout the study period, compared with that at baseline (Table 2). Although no significant intergroup difference in the severity of conjunctival congestion was observed at weeks 2 and 8, the conjunctival congestion was significantly less severe in the FML group at week 4 (P = 0.035), compared with that in the CsA group, indicating that the beneficial effect of the FML treatment was manifested more quickly at the conjunctiva than that of the CsA treatment.

Bottom Line: After 8 weeks of therapy, the conjunctival goblet cell density was significantly higher in both the groups (P < 0.001 for both) compared with the baseline values.Conjunctival congestion was reduced in both the groups throughout the study, and the severity in the FML group was significantly less at week 4 compared with that in the CsA group (P = 0.035).Treatment using topical 0.1% FML provided faster improvement in the symptoms of ocular dryness in SS patients compared with topical 0.5% CsA.

View Article: PubMed Central - PubMed

Affiliation: From the Department of Ophthalmology (TL, LG), Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.

ABSTRACT
The purpose of the study was to evaluate the efficacy of an ophthalmic solution containing 0.1% fluorometholone (FML) and 0.1% sodium hyaluronate (HA) for the treatment of ocular dryness in Sjögren syndrome (SS) patients.Forty SS patients were randomly assigned to the FML or cyclosporin A (CsA) treatment groups. The FML group was treated with 0.1% FML and 0.1% HA, and the CsA group was treated with 0.5% CsA and 0.1% HA. Primary outcomes were corneal fluorescein staining (CFS), the Ocular Surface Disease Index (OSDI) score, conjunctival goblet cell density, and the severity of conjunctival congestion. Patients were also evaluated based on tear film breakup time (TFBUT) and the Schirmer test. After 8 weeks of treatment, the mean CFS scores were significantly lower in both the groups, compared with the baseline values, and the CFS score of the FML group at week 2 was significantly lower than that of the CsA group (P = 0.042). The OSDI scores improved significantly in both the groups throughout the study, and the OSDI score in the FML group at week 4 was significantly lower than that of the CsA group (P = 0.042). After 8 weeks of therapy, the conjunctival goblet cell density was significantly higher in both the groups (P < 0.001 for both) compared with the baseline values. Conjunctival congestion was reduced in both the groups throughout the study, and the severity in the FML group was significantly less at week 4 compared with that in the CsA group (P = 0.035). The TFBUT in the FML group at week 8 was significantly longer than in the CsA group (P = 0.04). Treatment using topical 0.1% FML provided faster improvement in the symptoms of ocular dryness in SS patients compared with topical 0.5% CsA.

Show MeSH
Related in: MedlinePlus