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From:
Published online Jan 20, 2012. doi: 10.1186/1471-2431-12-8
Table 1
Paediatric licensing status and number of RCTs related to ocular medications
Pharmaco-therapeutic GroupDrug nameLicence StatusRCTs

ITUKUSAPublishedNon-published
ANTI-ALLERGY MEDICATIONS14/12*8/8*11/10*345

Anti-histamine agentAzelastine≥ 4 yrs≥ 12 yrs≥ 3 yrs4-

Emedastine≥ 3 yrs≥ 3 yrs≥ 3 yrs1-

Epinastine≥ 12 yrs≥ 12 yrs≥ 3 yrs--

Ketotifen≥ 3 yrs≥ 3 yrs≥ 3 yrs53

LevocabastineallNA**NA6-

Olopatadine≥ 3 yrs≥ 3 yrs≥ 3 yrs41

Mast cell stabilizerSpaglumic acidallNANA--

Lodoxamideall≥ 4 yrs> 2 yrs1-

Nedocromil sodium≥ 6 yrs≥ 6 yrs≥ 3 yrs5-

Sodium cromogligatens**allNA6-

PemirolastNANA≥ 3 yrs--

Decongestant (Sympathomimetic agent)Naphazoline≥ 10 yrsNAnl-1

Oxymetazoline≥ 3 yrsNA≥ 6 yrs--

Tetryzoline≥ 3 yrsNA≥ 6 yrs--

ANTI-ALLERGY COMBINATIONS3/31/12/200

Anti-histamine agent + DecongestantAntazoline + XylometazolineNA≥ 5 yrsNA--

Chlorpheniramine + Tetryzoline≥ 3 yrsNANA--

Pheniramine + Tetryzoline≥ 3 yrsNANA--

Mast cell stabilizer + DecongestantCromoglicate + Tetryzoline≥ 3 yrsNANA--

Astringent + DecogestantZinc sulfate + TetryzolineNANA≥ 6 yrs--

Decogestant + LubricantsTetryzoline + Povidone + Dextran 70 + Polyethylene glycol 400NANA≥ 6 yrs--

ANTI-GLAUCOMA MEDICATIONS23/614/16/143

Beta-blockerTimolol> 1 mnl**nl42

Carbonic anhydrase inhibitorDorzolamideallnlns-

Sympathomimetic agent (selective α2 - agonist)Apraclonidine≥ 12 yrs≥ 12 yrsnl--

Brimonidine≥ 12 yrsNA≥ 2 yrs-1

ClonidinensNANA--

Parasympathomimetic (colinergic) agentAceclidine≥ 3 yrsNANA--

Pilocarpine≥ 3 yrsnlNl--

ANTI-GLAUCOMA COMBINATIONS2/11/02/210

Beta-blocker + Carbonic anhydrase inhibitorTimolol + Dorzolamide≥ 2 yrsnl≥ 2 yrs1-

Beta-blocker + Sympathomimetic agentTimolol + BrimonidinenlNA≥ 2 yrs--

ANTI-INFLAMMATORY MEDICATIONS16/88/55/2166

Non-Steroidal Anti-Inflammatory Drug (NSAID)Diclofenac≥ 3 yrsnlnl41

Indomethacin≥ 3 yrsNANA--

KetorolacNAnl≥ 3 yrs3-

Steroid agentBetamethasoneNAallNA--

Desonide> 1 mNANA--

Dexamethasone> 1 mallnl62

Fluorometholone≥ 2 yrs≥ 2 yrs≥ 2 yrs31

Hydrocortisone> 1 mallNA--

PrednisoloneNAallnl-2

Clobetasone>1 mNANA--

Steroid agent + DecongestantFluorometholone + Tetryzoline≥ 2 yrsNANA--

Clobetasone + TetryzolinensNANA--

ANTI-INFECTIVE MEDICATIONS21/139/910/7273

Antibacterial agentChloramphenicol≥ 3 yrsallNA7-

Fusidic acidnsallNA3-

Propamidine isetionateNAallNA--

AminoglycosideGentamycin≥ 3 yrsall>1yr21

NeomycinNAallNA--

Netilmycin> 1 mNANA--

Tobramycin≥ 1 yrNAnl3-

QuinoloneCiprofloxacinall≥ 1 yr≥ 1 yr2-

GatifloxacinNANA≥ 1 yr-

Levofloxacin≥ 1 yr≥ 1 yr≥ 1 yr2-

Lomefloxacine≥ 1 yrNANA--

Moxifloxacin≥ 1 mnl≥ 1 yr3

Ofloxacinnl ophtalmia neonatorum> 1m≥ 1 yr1-

Antiviral agentAcyclovirallallnl--

Idoxuridine≥ 3 yrsNANA--

TrifluridineallNA≥ 6 yrs--

Other anti-infective agentPovidone - Iodine> 1 mNAnl42

ANTIBACTERIAL COMBINATIONS9/26/34/130

AntibacterialsPolimyxin B + TrimethoprimNAall> 2 ms1-

Polimyxin B + BacitracinNAallnl1-

Neomycin + Polymyxin B + GramicidinNA≥ 2 yrsnl--

Neomycin + ChloramphenicolnsNANA--

Antibacterial + SteroidNeomycin + Polymyxin B + Dexamethasonenlall≥ 2 yrs--

Neomycin + Polymyxin B + HydrocortisoneNANAns--

Neomycin + Chloramphenicol + HydrocortisonensNANA--

Neomycin + PrednisolonensallNA--

Neomycin + FluocinolonensNANA--

Neomycin + BetamethasoneNAallNA1-

Tobramycin + DexamethasonenlNA≥ 2 yrs--

Prednisolone + SulphacetamideNANA≥ 6 yrs--

Tobramycin + FluorometholoneNANA≥ 2 yrs--

Antibacterial + Steroid + DecongestantNeomycin + Gramicidin + Tetryzoline + Dexamethasone≥ 3 yrsNANA--

Betamethasone + Sulphacetamide + Tetryzoline≥ 2 yrsNANA--

MYDRIATIC/CYCLOPLEGIC MEDICATIONS7/46/52/1553

Antimuscarinic agentCyclopentolate≥ 3 yrs> 3 msall14-

Homatropinens> 3 msnl--

Tropicamide> 1 mallNA10-

Atropinens> 3 ms (nl uveitis)NA313

IbopamineallNANA--

Decongestant (Sympathomimetic agent)Phenylephrine≥ 12 yrsAll (nl 10% drops)NA2-

PERI-OPERATIVE MEDICATIONS2/04/41/040

Local anaestheticLidocainenlallnl2-

OxybuprocainensallNA1-

ProxymetacaineNAallNA--

TetracaineNAallNA1-

LUBRICANTS AND ASTRIGENTS5/010/54/000

Ocular lubricant and astringentPolyvinyl alcoholNsallNA--

Carmellose sodiumnsallNA--

HydroxyethylcelluloseNAallNA--

ParaffinNAallNA--

Sodium hyaluronatensallNA--

HypromelloseNAallnl--

LUBRICANT COMBINATIONS0/02/26/200

LubricantsHypromellose + GlycerinNANAall--

Hypromellose + Dextran 70NAallnl--

Hypromellose + Glycerin + Polyethylene glycol 400NANA≥ 6 yrs--

Lubricant + Steroid agentHypromellose + DexamethasoneNAallNA--

OTHER OCULAR MEDICATIONS2/12/22/100

Hypertonic agentSodium chlorideNAallNl--

Ocular diagnostic agentFluoresceinnsallNA--

Topical immunomodulatorCyclosporine 0.05%NANA≥ 16 yrs--

Other ocular agentHeparin> 1 mNANA--

TOTAL SINGLE DRUGS6888/4361/3941/2214020

TOTAL COMBINATIONS2916/710/614/74-
NOTE: Only drugs with a paediatric licence at least in one country are listed. The drugs in bold are listed in the WHO model list of essential medicines for children.
* N° drugs marketed/N° drugs marketed with paediatric licence
** ns: not specified; nl: not licensed for paediatric use; NA: not authorised
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