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Efficacy of azithromycin 1% and 1.5% ophthalmic solutions compared to tobramycin 0.3% eye drops: A systematic review and meta-analysis

ABSTRACT: Background: Azithromycin 1% and 1.5% ophthalmic preparations are used widely in clinical practice for the treatment of signs and symptoms of eye diseases. The aim of this study was to render conclusive evidence by comparing the efficacy of azithromycin 1% and 1.5% over tobramycin 0.3% ophthalmic solutions for the treatment of eye diseases in a short duration in terms of bacterial resolution, the cure rate, and resolving clinical sign and symptoms. Methods: Systematic searches were performed in the electronic database (MEDLINE, Embase, Emcare, CINAHL, Scopus, PubMed, ProQuest, and Web of Science) and other sources. Multicenter randomized controlled trial studies conducted in English were identified and screened. Analysis of individual studies was conducted using the OpenMeta-analyst and Review Manager Version 5.3 software. Results: Eleven studies were included in the systematic review and meta-analysis. In clinical cure rate, azithromycin 1% and 1.5% eye drops were more effective than tobramycin 0.3% eye drops in short duration dosing (?5?days) with a twice-a-day regimen (relative risk?=?1.13; 95% confidence interval: 1.008, 1.28), whereas on increased duration (>5?days), azithromycin is almost similarly as effective as tobramycin (relative risk?=?1.007; 95% confidence interval: 0.96, 1.05). There was no significant difference in efficacy of bacterial resolution of azithromycin (1%, 1.5%) eye drops compared to tobramycin (0.3%) eye drops (relative risk?=?0.99; 95% confidence interval: 0.96, 1.018). Azithromycin eye drops are effective in improving the signs and symptoms of eye disease. Conclusion: Azithromycin 1% or 1.5% is more effective in the clinical cure rate of eye disease than tobramycin 0.3% eye drops in ?5?days of treatment. It is also the best choice of treatment for improving the signs and symptoms of eye disease. So that we recommend clinicians to use azithromycin 1% or 1.5% eye drops. Systematic Review Registration: PROSPERO 2019 CRD42019139911

SUBMITTER: Alemu B

PROVIDER: S-EPMC7502802 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:PurposeTo evaluate the safety and efficacy of ophthalmic MIM-D3, a tyrosine kinase TrkA receptor agonist, in patients with dry eye.DesignA prospective, two-center, randomized, double-masked, placebo-controlled Phase 2 study.MethodsA total of 150 dry eye patients were randomized 1:1:1 to study medication (1% MIM-D3, 5% MIM-D3, or placebo) and dosed twice daily (BID) for 28 days. Key eligibility criteria included exacerbation in corneal staining and ocular discomfort in the Controlled Adverse Environment (CAE(SM)) on two visits, separated by 1 week of BID dosing with artificial tears. Safety and efficacy were evaluated at baseline, throughout treatment, and for 2 weeks post-treatment. The pre-specified primary outcome measures were fluorescein corneal staining post-CAE at day 28 and diary worst symptom scores over 28 days. Secondary outcomes included the pre-, post-, and the change from pre- to post-CAE fluorescein and lissamine green staining in both corneal and conjunctival regions, as well as individual diary symptoms.ResultsThe prespecified primary endpoints were not met. Compared with placebo, fluorescein corneal staining at day 28 was significantly improved (P < 0.05) in the 1% MIM-D3 group for the assessment of change from pre-CAE to post-CAE. In addition, following CAE exposure, patients in the 1% MIM-D3 group showed significant improvements versus placebo (P < 0.05) in inferior fluorescein and lissamine green staining after 14 and 28 days. Compared with placebo, patients in the 5% MIM-D3 group reported significantly lower daily diary scores for ocular dryness (P < 0.05). In a subgroup defined by higher symptom scores during the run-in period, significant treatment effects (P < 0.05) were observed for diary symptoms for both MIM-D3 doses. Ocular adverse events were mild and not considered to be treatment-related.ConclusionTreatment with topical ophthalmic MIM-D3 demonstrated protection against the effects of a CAE challenge on dry eye signs, reduced patient-reported diary symptoms, with a favorable safety profile.

Project description:BACKGROUND:Dry eye may be caused or exacerbated by deficient lipid secretion. Recently, lipid-containing artificial tears have been developed to alleviate this deficiency. Our study compared the efficacy, safety, and acceptability of lipid-containing eye drops with that of aqueous eye drops. METHODS:A non-inferiority, randomized, parallel-group, investigator-masked multicenter trial was conducted. Subjects with signs and symptoms of dry eye were randomized to use one of two lipid-containing artificial tears, or one of two aqueous artificial tears. Subjects instilled assigned drops in each eye at least twice daily for 30 days. The primary efficacy analysis tested non-inferiority of a preservative-free lipid tear formulation (LT UD) to a preservative-free aqueous tear formulation (AqT UD) for change in Ocular Surface Disease Index (OSDI) score from baseline at day 30. Secondary measures included OSDI at day 7, tear break-up time (TBUT), corneal and conjunctival staining, Schirmer's test, acceptability and usage questionnaires, and safety assessments. RESULTS:A total of 315 subjects were randomized and included in the analyses. Subjects reported instilling a median of three doses of study eye drops per day in all groups. At days 7 and 30, all groups showed statistically significant improvements from baseline in OSDI (P<0.001) and TBUT (P?0.005). LT UD was non-inferior to AqT UD for mean change from baseline in OSDI score at day 30. No consistent or clinically relevant differences for the other efficacy variables were observed. Acceptability was generally similar across the groups and there was a low incidence of adverse events. CONCLUSION:In this heterogeneous population of dry eye subjects, there were no clinically significant differences in safety, effectiveness, and acceptability between lipid-containing artificial tears and aqueous eye drops. The results suggest that lipid-containing artificial tears can be used to counteract lipid deficiency that is common in dry eye, without compromising overall acceptability.

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Efficacy of azithromycin 1% and 1.5% ophthalmic solutions compared to tobramycin 0.3% eye drops: A systematic review and meta-analysis

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