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

Joon Ho Park; Jun Hun Lee; Young Jeung Park; Hong Kyun Kim

doi:10.3341/jkos.2013.54.2.215

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Park, Lee, Park, and Kim: Efficacy and Safety of Topical Unpreserved 0.1% Fluorometholone Ophthalmic Solution on Dry Eye Syndrome

Original Article

J Korean Ophthalmol Soc 2007;54(2):215-223.

Published online: 24 August 2007

DOI: https://doi.org/10.3341/jkos.2013.54.2.215

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

Joon Ho Park, MD¹, Jun Hun Lee, MD¹, Young Jeung Park, MD, PhD², Hong Kyun Kim, MD, PhD¹

¹Department of Ophthalmology, Kyungpook National University School of Medicine, Daegu, Korea

²Cheil Eye Hospital, Daegu, Korea

Address reprint requests to Hong Kyun Kim, MD, PhD, Department of Ophthalmology, Kyungpook National University Hospital, #130 Dongdeok-ro, Jung-gu, Daegu 700-721, Korea Tel: 82-53-420-5801, Fax: 82-53-426-6552, E-mail: okeye@knu.ac.kr

Received 20 April 201225 September 2012 Accepted 21 January 2013

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Dry eye syndrome, Tear film parameters, Topical unpreserved 0.1% fluorometholone

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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.

Table 1.

Clinical characteristics and tear film and ocular surface parameters of the patients

Group	Trial 1		p-value	Trial 2		p-value
Group	Group 1 (n = 19)	Group 2 (n = 25)	p-value	Group 3 (n = 14)	Group 1 (n = 22)	p-value	Group 2 (n = 26)
Age (mean ± SD, year)	50.0 ± 8.23	51.66 ± 8.38	51.1 ± 2.95	0.752^†	50.0 ± 9.32	48.0 ± 10.42	0.604^‡
Sex, n				0.075^∗			0.516^∗
Male	2	3	0		2	4
Female	17	23	14		20	22
OSDI (mean ± SD)	53.21 ± 19.21	51.71 ± 19.76	54.15 ± 18.87	0.926^†	60.15 ± 28.07	59.15 ± 19.27	0.605^‡
TF-BUT (mean ± SD, sec)	2.82 ± 1.24	2.72 ± 0.84	2.86 ± 1.51	0.927^†	2.65 ± 1.38	2.44 ± 1.42	0.504^‡
OSS (mean ± SD, score)	3.93 ± 1.38	3.64 ± 1.68	3.86 ± 1.56	0.838^†	5.55 ± 3.25	5.6 ± 2.53	0.836^‡
Tosm (mean ± SD, mosm)	310.64 ± 14.49	310.83 ± 15.11	315.71 ± 29.28	0.414^†	322.57 ± 13.29	319.62 ± 16.97	0.392^‡

OSDI = ocular surface disease index; TF-BUT = tear film break-up time; OSS = oxford stain score; Tosm = tear osmolarity; SD = standard deviation.

^∗By Fisher's exact test; ^†By ANOVA test; ^‡By Two-sample t test.

Table 2.

Changes in the tear film and ocular surface parameters in Trial 1

	Group I	Group II	Group III	p-value
OSDI (mean ± SD)
2 weeks	48.42 ± 19.57	36.69 ± 13.14	36.23 ± 18.28	0.056
4 weeks	40.09 ± 14.23	32.59 ± 15.22	43.36 ± 11.87	0.058
8 weeks	40.53 ± 17.21	31.53 ± 11.30	41.37 ± 14.45	0.059
12 weeks	38.54 ± 16.06	30.23 ± 13.52	41.64 ± 16.90	0.058
TF-BUT (mean ± SD, sec)
2 weeks	3.17 ± 0.88	3.91 ± 1.31	3.93 ± 1.21	0.104
4 weeks	3.69 ± 1.45	4.09 ± 1.60	3.85 ± 1.10	0.689
8 weeks	4.06 ± 1.39	4.26 ± 1.41	4.00 ± 1.04	0.829
12 weeks	4.00 ± 1.41	4.21 ± 1.44	3.92 ± 1.07	0.816
OSS (mean ± SD, score)
2 weeks	3.25 ± 1.73	1.84 ± 0.62	2.71 ± 0.47	<0.001^∗,†
4 weeks	3.34 ± 1.54	1.76 ± 0.83	2.86 ± 1.10	<0.001^∗,†
8 weeks	3.07 ± 1.49	1.60 ± 1.00	2.43 ± 1.28	0.002^∗
12 weeks	2.79 ± 1.31	1.76 ± 1.10	2.29 ± 0.91	0.026^∗
Tosm (mean ± SD, mosm)
4 weeks	306 ± 14.40	295.2 ± 19.11	306.67 ± 12.70	0.382
8 weeks	299.6 ± 14.36	288.33 ± 7.64	306.75 ± 15.22	0.254
12 weeks	294.0 ± 10.98	283.33 ± 5.77	301.50 ± 6.36	0.108

OSDI = ocular surface disease index; TF-BUT = tear film break-up time; OSS = oxford stain score; Tosm = tear osmolarity; SD = standard deviation.

^∗Significant (p < 0.05) difference between control group and UFL group; ^†Significant difference between UFL group and PFL group.

Table 3.

Abnormal response to eyedrops

	UFL	PFL
FB sensation	1	1
Stinging/Burning sensation	1	1
Pain/Discomfort	0	3
Tearing	0	0
Itching	0	0
	8% (2/22)	35.7% (5/14)

FB = foreign body; UFL = unpreserved 0.1% fluorometholone; PFL = preserved 0.1% fluorometholone.

Table 4.

Changes in the tear film and ocular surface parameters in Trial 2

	Group I	Group II	p-value
OSDI (mean ± SD)
2 weeks	45.99 ± 21.63	43.82 ± 23.22	0.761
4 weeks	41.41 ± 20.59	44.79 ± 20.27	0.578
8 weeks	39.71 ± 21.71	42.48 ± 19.67	0.713
12 weeks	42.86 ± 21.51	37.36 ± 17.29	0.406
TF-BUT (mean ± SD, sec)
2 weeks	3.90 ± 2.17	3.56 ± 1.72	0.594
4 weeks	4.15 ± 1.93	3.59 ± 1.97	0.401
8 weeks	4.00 ± 1.72	4.17 ± 2.12	0.814
12 weeks	4.00 ± 1.46	4.30 ± 2.36	0.691
OSS (mean ± SD, score)
2 weeks	5.00 ± 2.92	5.05 ± 2.16	0.334
4 weeks	5.05 ± 2.16	4.12 ± 2.12	0.208
8 weeks	4.94 ± 3.34	3.91 ± 3.60	0.446
12 weeks	3.93 ± 2.12	3.30 ± 3.27	0.561
Tosm (mean ± SD, mosm)
4 weeks	302.18 ± 18.93	296.25 ± 16.49	0.431
8 weeks	305.89 ± 16.20	296.55 ± 12.18	0.158
12 weeks	302.89 ± 12.22	297.5 ± 12.40	0.354

OSDI = ocular surface disease index; TF-BUT = tear film break-up time; OSS = oxford stain score; Tosm = tear osmolarity; SD = standard deviation.

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