Limits...
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.

Show MeSH

Related in: MedlinePlus

The mean OSDI during 8 weeks follow-up. +Significantly different from the baseline value (FML group: P < 0.001 at weeks 2, 4, and 8; CsA group: P = 0.007 at week 2, P < 0.001 at weeks 4 and 8). ∗Significant intergroup difference (P = 0.042 at week 4). CsA = cyclosporine, FML = fluorometholone, OSDI = Ocular Surface Disease Index, W = week.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4554178&req=5

Figure 4: The mean OSDI during 8 weeks follow-up. +Significantly different from the baseline value (FML group: P < 0.001 at weeks 2, 4, and 8; CsA group: P = 0.007 at week 2, P < 0.001 at weeks 4 and 8). ∗Significant intergroup difference (P = 0.042 at week 4). CsA = cyclosporine, FML = fluorometholone, OSDI = Ocular Surface Disease Index, W = week.

Mentions: The mean OSDI score in the FML group decreased significantly across all of the time points, compared with the baseline value (P < 0.001 for all) (Figure 4). However, the mean OSDI score in the FML group at week 4 did not differ significantly from that at week 8 (P = 0.573). The mean OSDI score in the CsA group was significantly lower at week 2 compared with the baseline value (P = 0.007). The mean OSDI score in the CsA group at week 8 was significantly lower that at week 4 (P < 0.001), whereas the mean OSDI score for the CsA group at week 2 did not differ significantly for that at week 4 (P = 0.164). At week 4, the mean OSDI score in the FML group was significantly lower than the CsA group (P = 0.042) (Figure 4). However, no significant difference in the mean OSDI score was observed between the 2 groups at weeks 2 and 8 (P = 0.116 and 0.456, respectively).


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

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

The mean OSDI during 8 weeks follow-up. +Significantly different from the baseline value (FML group: P < 0.001 at weeks 2, 4, and 8; CsA group: P = 0.007 at week 2, P < 0.001 at weeks 4 and 8). ∗Significant intergroup difference (P = 0.042 at week 4). CsA = cyclosporine, FML = fluorometholone, OSDI = Ocular Surface Disease Index, W = week.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 4: The mean OSDI during 8 weeks follow-up. +Significantly different from the baseline value (FML group: P < 0.001 at weeks 2, 4, and 8; CsA group: P = 0.007 at week 2, P < 0.001 at weeks 4 and 8). ∗Significant intergroup difference (P = 0.042 at week 4). CsA = cyclosporine, FML = fluorometholone, OSDI = Ocular Surface Disease Index, W = week.
Mentions: The mean OSDI score in the FML group decreased significantly across all of the time points, compared with the baseline value (P < 0.001 for all) (Figure 4). However, the mean OSDI score in the FML group at week 4 did not differ significantly from that at week 8 (P = 0.573). The mean OSDI score in the CsA group was significantly lower at week 2 compared with the baseline value (P = 0.007). The mean OSDI score in the CsA group at week 8 was significantly lower that at week 4 (P < 0.001), whereas the mean OSDI score for the CsA group at week 2 did not differ significantly for that at week 4 (P = 0.164). At week 4, the mean OSDI score in the FML group was significantly lower than the CsA group (P = 0.042) (Figure 4). However, no significant difference in the mean OSDI score was observed between the 2 groups at weeks 2 and 8 (P = 0.116 and 0.456, respectively).

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