J Korean Ophthalmol Soc.  2013 Feb;54(2):215-223. 10.3341/jkos.2013.54.2.215.

Efficacy and Safety of Topical Unpreserved 0.1% Fluorometholone Ophthalmic Solution on Dry Eye Syndrome

• Park JH
• Lee JH
• Park YJ
• Kim HK

• KMID: 2216655
• DOI: http://doi.org/10.3341/jkos.2013.54.2.215

Abstract

PURPOSE
To evaluate the efficacy and safety of topical unpreserved 0.1% fluorometholone (FML) ophthalmic solution in patients with dry eye syndrome.
METHODS
Patients with mild to moderate dry eye syndrome were divided into the control group (Group I), topical unpreserved 0.1% FML group (Group II), and topical preserved 0.1% FML group (Group III). Intraocular pressure (IOP), Ocular Surface Disease Index (OSDI), tear film break-up time (TF-BUT), Oxford stain score (OSS), and tear osmolarity (Tosm) were evaluated at 2 weeks, 4 weeks, 8 weeks, and 12 weeks (Trial 1). Patients with severe dry eye syndrome were divided into 1% methylprednisolone (MP) group (Group I) and 0.1% unpreserved FML group (Group II). Same parameters were evaluated in both groups (Trial 2).
RESULTS
In clinical trial I, OSS scores of Group II were lower than other groups (p < 0.05). For severe dry eye patients in clinical trial 2, there were no significant differences in all parameters between the 2 groups.
CONCLUSIONS
Topical unpreserved 0.1% fluorometholone was shown to be an effective and relatively safe treatment in patients with dry eye syndrome.

Keyword

Dry eye syndrome; Tear film parameters; Topical unpreserved 0.1% fluorometholone

MeSH Terms

Dry Eye Syndromes
Eye
Fluorometholone
Humans
Intraocular Pressure
Methylprednisolone
Osmolar Concentration
Tears
Fluorometholone
Methylprednisolone

Figure

• 

  Figure 1. Trial 1 study flow chart. OSDI = ocular surface disease index; TF-BUT = tear film break-up time; OSS = oxford stain score.

• 

  Figure 2. Trial 2 study flow chart. UFL = unpreserved 0.1% Fluorometholone; MP = Methylprednisolone; OSDI = ocular surface disease index; TF-BUT = tear film break-up time; OSS = oxford stain score.

• 

  Figure 3. Changes in the tear film and ocular surface parameters in Trial 1. OSS scores of Group II are lower than other groups at 2 weeks and 4 weeks (p < 0.05). The other parameters were not significant between the 3 groups. Pairwise comparison p-values are represented by ∗significant (p < 0.05) difference between control group and UFL group; †significant difference between UFL group and PFL group. UFL = unpreserved 0.1% fluorometholone; PFL = preserved 0.1% fluorometholone; OSDI = ocular surface disease index; TF-BUT = tear film break-up time; OSS = oxford stain score; Tosm = tear osmolarity.

• 

  Figure 4. Changes in the tear film and ocular surface parameters in Trial 2. There were no significant differences in all parameters between the 2 groups. UFL = unpreserved 0.1% fluorometholone; MP = methylprednisolone; OSDI = ocular surface disease index; TF-BUT = tear film break-up time; OSS = oxford stain score; Tosm = tear osmolarity.

• 

  Figure 5. Changes in the intraocular pressure in Trial 2. Group 1 showed higher mean IOP at 4 weeks than group 2. But the value was not statistically significant (p = 0.077). UFL = un-preserved 0.1% fluorometholone; M P = methylprednisolone; IOP = intraocular pressure.

Reference

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