fluorometholone
Regulatory sources consulted
Approved indications
- Inflammatory and pruritic manifestations of dermatitis, neurodermatitis, eczema, psoriasis, nontuberculous discoid lupus, and lichen planus.
Contraindications
Absolute
- Hypersensitivity to fluorometholone, urea, or excipients; cutaneous tuberculosis or syphilis, vaccination reaction, bacterial, viral, or fungal infection, rosacea, or perioral dermatitis.
Clinical warnings
- Major warning · Use the smallest effective amount for the shortest possible time. Large areas, prolonged use, an impaired skin barrier, and occlusion increase absorption and may cause reversible HPA-axis suppression, Cushing syndrome, hyperglycemia, or glucosuria; children are more susceptible. — CIMA/AEMPS, ficha técnica 53774
- Avoid eye contact. Stop if irritation or sensitization occurs. Treat any skin infection; if it does not respond promptly, stop the corticosteroid until it is controlled. — CIMA/AEMPS, ficha técnica 53774
- Major warning · Avoid the eyes, nearby areas, and mucous membranes. Excessive, occlusive, or periocular application may promote glaucoma. Psoriasis requires close supervision. — CIMA/AEMPS, ficha técnica 53774
- Major warning · Urea has been associated with skin irritation, erythema, and ischemic necrosis; frequency is not established. — CIMA/AEMPS, ficha técnica 53774
Pregnancy and lactation
Avoid during pregnancy unless benefit justifies risk; particularly avoid the first trimester, large areas, prolonged use, or occlusion. During breastfeeding, decide whether to stop breastfeeding or stop treatment and do not apply to the breast.
Recent literature (PubMed)
Corneal injuries can occur secondary to traumatic, chemical, inflammatory, metabolic, autoimmune, and iatrogenic causes. Ocular infection may frequently occur concurrent to corneal injury; however, antimicrobial agents are excluded from this present review. While practitioners may primarily rely on clinical examination techniques to assess these injuries, several pharmacological agents, such as fluorescein, lissamine green, and rose bengal, can be used to formulate a diagnosis and develop effective treatment strategies. Practitioners may choose from several analgesic medications to help with patient comfort without risking further injury or delaying ocular healing. Atropine, cyclopentolate, scopolamine, and homatropine are among the most frequently used medications for this purpose. Additional topical analgesic agents may be used judiciously to augment patient comfort to facilitate diagnosis. Steroidal anti-inflammatory agents are frequently used as part of the therapeutic regimen. A variety of commonly used agents, including prednisolone acetate, loteprednol, difluprednate, dexamethasone, fluorometholone, and methylprednisolone are discussed. While these medications are effective for controlling ocular inflammation, side effects, such as elevated intraocular pressure and cataract formation, must be monitored by clinicians. Non-steroidal medications, such as ketorolac, bromfenac, nepafenac, and diclofenac, are additionally used for their efficacy in controlling ocular inflammation without incurring side effects seen with steroids. However, these agents have their own respective side effects, warranting close monitoring by clinicians. Additionally, ophthalmologists routinely employ several agents in an off-label manner for supplementary control of inflammation and treatment of corneal injuries. Patients with corneal injuries not infrequently have significant ocular surface disease, either as a concurrent pathology or as an exacerbation of previously existing disease.
The prevalence of rejection is 10-30% in penetrating keratoplasty (PKP) case, and the rate is higher in cases of high-risk patients. Although using topical corticosteroids is a standard method for management the rejection of post-PKP patients, it may not be sufficiently potent in high-risk patients. Topical administration of tacrolimus (TAC) may be effective in suppression rejection after corneal transplantation. This study aimed to investigate the efficacy and safety of topical TAC in high-risk PKP patients in Japan. This study was a single centre, single-blinded, randomized controlled trial. Patients with a history of PKP, graft rejection, atopic dermatitis, or deep corneal neovascularisation who underwent PKP were enrolled. They were randomly assigned to receive 0.1% TAC ophthalmic suspension or artificial tear (AT) up to week 52 after surgery. All participants received 0.1% betamethasone up to week 13 after surgery then they received 0.1% fluorometholone up to week 52. The incidence of immunological rejection during the observation period was the main outcome measure in this study. Thirty patients were enrolled in this study, and 12 eyes in the TAC group and 13 eyes in the AT group completed the study, respectively. Five out of 30 patients discontinued participation after providing informed consent. No serious adverse effects were developed in patients who received 0.1% TAC ophthalmic suspension. No rejection episodes occurred in the TAC group, while one eye in the AT group had rejection. Graft clarity, best spectacle-corrected visual acuity, intraocular pressure, and corneal endothelial cell density were not significantly different between the TAC and AT groups. Our results demonstrated that good tolerability of 0.1% TAC ophthalmic suspension. However, we failed to demonstrate its efficacy in preventing immunological rejection in high-risk patients undergoing PKP. This study was first registered in the University Hospital Medical Information Network (UMIN000029
Cytomegalovirus (CMV) corneal endotheliitis often causes severe visual impairment owing to irreversible corneal endothelial dysfunction. Given the side effects of systemic antiviral therapy, development of an approved topical antiviral agent for CMV corneal endotheliitis is desirable. This study evaluated the efficacy and safety of topical 0.15% GCV gel, ROH-101, in the treatment of CMV corneal endotheliitis in Japanese patients. Open-label, multicenter, uncontrolled, phase 3 study (jRCT2051210064). The study was conducted from August 2021 to December 2022, with a 2-week run-in period with 0.1% fluorometholone eye drops alone, a 12-week treatment period with additional ROH-101, and a 24-week post-treatment observation period after discontinuation of ROH-101. The primary endpoint was the proportion of patients achieving a CMV DNA copy number in the aqueous humor of less than 103 copies/mL at week 12. The clinical findings and safety were assessed over the treatment and post-treatment observation periods. Twelve eyes of 12 patients with PCR-proven CMV corneal endotheliitis were enrolled. Treatment was discontinued in 1 eye owing to an adverse event. The other 11 eyes completed 12 weeks of treatment with 63.6% achieving the primary endpoint. The clinical findings, such as corneal edema, coin-shaped lesions, and anterior chamber inflammation, improved in all 11 eyes and did not worsen in 8 eyes that completed the post-treatment observation period. Endothelial cell density was well maintained, and none of the 11 eyes showed corneal endothelial dysfunction. Mild adverse drug reactions were reported in 3 eyes (8.3%). ROH-101 was a safe and efficacious treatment in Japanese patients diagnosed with CMV corneal endotheliitis.
To evaluate the efficacy of preventive treatment against allograft rejection after endothelial keratoplasty (EK), we conducted a systematic review and meta-analysis. PubMed, Cochrane Library, Embase and ScienceDirect databases were searched until May 2021. We computed a random-effect meta-analysis on graft rejection rate stratified by the intervention (i.e. Descemet membrane EK (DMEK) and Descemet stripping (Automated) EK (DS(A)EK) or ultrathin (UT)-DSAEK), and postoperative treatment. Meta-regressions were performed to compare intervention, treatment and influence of putative confusion factors. We included 49 studies and 12 893 EK (6867 DMEK and 6026 DS(A)EK/UT-DSAEK). Topical steroids were merged in two efficacy regimens: standard steroids (prednisolone acetate 1% or dexamethasone 0.1%) and soft steroids (fluorometholone 0.1% or loteprednol etabonate 0.5%). Globally, DMEK had a lower graft rejection rate than DS(A)EK/UT-DSAEK (coefficient - 3.3, 95 CI, -4.60 to -1.90; p < 0.001). No significant differences were observed between standard and soft steroids to prevent graft rejection after DMEK. After EK, the rate of ocular hypertension was 20% (95 CI, 14 to 26%) with the use of standard steroids and 7% (5 to 9%) with soft steroids. Comparisons of treatments were not feasible in DS(A)EK/UT-DSAEK due to a lack of studies. Descemet membrane endothelial keratoplasty (DMEK) has less risk of graft rejection compared with DS(A)EK/UT-DSAEK. Furthermore, soft steroids seemed to be a valuable alternative to standard steroids to prevent graft rejection after DMEK, involving a safe profile against ocular hypertension. Further studies are needed to compare other drugs in the prevention of graft rejection after EK.
This study aimed to compare the anti-inflammatory efficacy and safety of 0.1% Fluorometholone (FML) versus (vs.) 0.5% Loteprednol etabonate (LE) following photorefractive keratectomy (PRK). A triple-blinded randomized controlled trial was conducted on both eyes of 100 patients with stable refraction who were candidates for PRK. Both eyes in each subject were randomly allocated to the FML or LE groups. The product to be tested was 0.1% FML eye drops packaged in droppers vs. the 0.5% LE sterile ophthalmic suspension (Lotemax®) packaged in identical droppers. The main clinical outcomes were changes in best-corrected distance visual acuity (BCDVA) and corneal optical density. The second clinical outcomes were a change in intraocular pressure (IOP) after the intervention. There was no significant difference regarding mean corneal optical density changes between the two groups, one (P = 0.55) and three months (P = 0.98) after the intervention. The mean ± SD BCDVA after one month of the intervention was 0.79 ± 0.11 and 0.84 ± 0.11 in LE and FML groups, retrospectively (P = 0.02). There was no significant difference regarding mean BCDVA between the two groups three months after intervention (P = 0.21). The IOP showed no significant difference between the two groups after one (P = 0.18) and three months (P = 0.53) of the intervention. The results of this clinical trial demonstrate that LE and FML treatment was effective with no clinically meaningful effect on IOP following a short course of treatment.