Table 1 Paediatric licensing status and number of RCTs related to ocular medications
From: Ocular medicines in children: the regulatory situation related to clinical research
Pharmaco-therapeutic Group | Drug name | Licence Status | RCTs | |||
|---|---|---|---|---|---|---|
| Â | Â | IT | UK | USA | Published | Non-published |
ANTI-ALLERGY MEDICATIONS | Â | 14/12* | 8/8* | 11/10* | 34 | 5 |
Anti-histamine agent | Azelastine | ≥ 4 yrs | ≥ 12 yrs | ≥ 3 yrs | 4 | - |
|  | Emedastine | ≥ 3 yrs | ≥ 3 yrs | ≥ 3 yrs | 1 | - |
|  | Epinastine | ≥ 12 yrs | ≥ 12 yrs | ≥ 3 yrs | - | - |
|  | Ketotifen | ≥ 3 yrs | ≥ 3 yrs | ≥ 3 yrs | 5 | 3 |
| Â | Levocabastine | all | NA** | NA | 6 | - |
|  | Olopatadine | ≥ 3 yrs | ≥ 3 yrs | ≥ 3 yrs | 4 | 1 |
Mast cell stabilizer | Spaglumic acid | all | NA | NA | - | - |
|  | Lodoxamide | all | ≥ 4 yrs | > 2 yrs | 1 | - |
|  | Nedocromil sodium | ≥ 6 yrs | ≥ 6 yrs | ≥ 3 yrs | 5 | - |
| Â | Sodium cromogligate | ns** | all | NA | 6 | - |
|  | Pemirolast | NA | NA | ≥ 3 yrs | - | - |
Decongestant (Sympathomimetic agent) | Naphazoline | ≥ 10 yrs | NA | nl | - | 1 |
|  | Oxymetazoline | ≥ 3 yrs | NA | ≥ 6 yrs | - | - |
|  | Tetryzoline | ≥ 3 yrs | NA | ≥ 6 yrs | - | - |
ANTI-ALLERGY COMBINATIONS | Â | 3/3 | 1/1 | 2/2 | 0 | 0 |
Anti-histamine agent + Decongestant | Antazoline + Xylometazoline | NA | ≥ 5 yrs | NA | - | - |
|  | Chlorpheniramine + Tetryzoline | ≥ 3 yrs | NA | NA | - | - |
|  | Pheniramine + Tetryzoline | ≥ 3 yrs | NA | NA | - | - |
Mast cell stabilizer + Decongestant | Cromoglicate + Tetryzoline | ≥ 3 yrs | NA | NA | - | - |
Astringent + Decogestant | Zinc sulfate + Tetryzoline | NA | NA | ≥ 6 yrs | - | - |
Decogestant + Lubricants | Tetryzoline + Povidone + Dextran 70 + Polyethylene glycol 400 | NA | NA | ≥ 6 yrs | - | - |
ANTI-GLAUCOMA MEDICATIONS | Â | 23/6 | 14/1 | 6/1 | 4 | 3 |
Beta-blocker | Timolol | > 1 m | nl** | nl | 4 | 2 |
Carbonic anhydrase inhibitor | Dorzolamide | all | nl | ns | - | Â |
Sympathomimetic agent (selective α 2 - agonist) | Apraclonidine | ≥ 12 yrs | ≥ 12 yrs | nl | - | - |
|  | Brimonidine | ≥ 12 yrs | NA | ≥ 2 yrs | - | 1 |
| Â | Clonidine | ns | NA | NA | - | - |
Parasympathomimetic (colinergic) agent | Aceclidine | ≥ 3 yrs | NA | NA | - | - |
|  | Pilocarpine | ≥ 3 yrs | nl | Nl | - | - |
ANTI-GLAUCOMA COMBINATIONS | Â | 2/1 | 1/0 | 2/2 | 1 | 0 |
Beta-blocker + Carbonic anhydrase inhibitor | Timolol + Dorzolamide | ≥ 2 yrs | nl | ≥ 2 yrs | 1 | - |
Beta-blocker + Sympathomimetic agent | Timolol + Brimonidine | nl | NA | ≥ 2 yrs | - | - |
ANTI-INFLAMMATORY MEDICATIONS | Â | 16/8 | 8/5 | 5/2 | 16 | 6 |
Non-Steroidal Anti-Inflammatory Drug (NSAID) | Diclofenac | ≥ 3 yrs | nl | nl | 4 | 1 |
|  | Indomethacin | ≥ 3 yrs | NA | NA | - | - |
|  | Ketorolac | NA | nl | ≥ 3 yrs | 3 | - |
Steroid agent | Betamethasone | NA | all | NA | - | - |
| Â | Desonide | > 1 m | NA | NA | - | - |
| Â | Dexamethasone | > 1 m | all | nl | 6 | 2 |
|  | Fluorometholone | ≥ 2 yrs | ≥ 2 yrs | ≥ 2 yrs | 3 | 1 |
| Â | Hydrocortisone | > 1 m | all | NA | - | - |
| Â | Prednisolone | NA | all | nl | - | 2 |
| Â | Clobetasone | >1 m | NA | NA | - | - |
Steroid agent + Decongestant | Fluorometholone + Tetryzoline | ≥ 2 yrs | NA | NA | - | - |
| Â | Clobetasone + Tetryzoline | ns | NA | NA | - | - |
ANTI-INFECTIVE MEDICATIONS | Â | 21/13 | 9/9 | 10/7 | 27 | 3 |
Antibacterial agent | Chloramphenicol | ≥ 3 yrs | all | NA | 7 | - |
| Â | Fusidic acid | ns | all | NA | 3 | - |
| Â | Propamidine isetionate | NA | all | NA | - | - |
Aminoglycoside | Gentamycin | ≥ 3 yrs | all | >1yr | 2 | 1 |
| Â | Neomycin | NA | all | NA | - | - |
| Â | Netilmycin | > 1 m | NA | NA | - | - |
|  | Tobramycin | ≥ 1 yr | NA | nl | 3 | - |
Quinolone | Ciprofloxacin | all | ≥ 1 yr | ≥ 1 yr | 2 | - |
|  | Gatifloxacin | NA | NA | ≥ 1 yr | - |  |
|  | Levofloxacin | ≥ 1 yr | ≥ 1 yr | ≥ 1 yr | 2 | - |
|  | Lomefloxacine | ≥ 1 yr | NA | NA | - | - |
|  | Moxifloxacin | ≥ 1 m | nl | ≥ 1 yr | 3 |  |
|  | Ofloxacin | nl ophtalmia neonatorum | > 1m | ≥ 1 yr | 1 | - |
Antiviral agent | Acyclovir | all | all | nl | - | - |
|  | Idoxuridine | ≥ 3 yrs | NA | NA | - | - |
|  | Trifluridine | all | NA | ≥ 6 yrs | - | - |
Other anti-infective agent | Povidone - Iodine | > 1 m | NA | nl | 4 | 2 |
ANTIBACTERIAL COMBINATIONS | Â | 9/2 | 6/3 | 4/1 | 3 | 0 |
Antibacterials | Polimyxin B + Trimethoprim | NA | all | > 2 ms | 1 | - |
| Â | Polimyxin B + Bacitracin | NA | all | nl | 1 | - |
|  | Neomycin + Polymyxin B + Gramicidin | NA | ≥ 2 yrs | nl | - | - |
| Â | Neomycin + Chloramphenicol | ns | NA | NA | - | - |
Antibacterial + Steroid | Neomycin + Polymyxin B + Dexamethasone | nl | all | ≥ 2 yrs | - | - |
| Â | Neomycin + Polymyxin B + Hydrocortisone | NA | NA | ns | - | - |
| Â | Neomycin + Chloramphenicol + Hydrocortisone | ns | NA | NA | - | - |
| Â | Neomycin + Prednisolone | ns | all | NA | - | - |
| Â | Neomycin + Fluocinolone | ns | NA | NA | - | - |
| Â | Neomycin + Betamethasone | NA | all | NA | 1 | - |
|  | Tobramycin + Dexamethasone | nl | NA | ≥ 2 yrs | - | - |
|  | Prednisolone + Sulphacetamide | NA | NA | ≥ 6 yrs | - | - |
|  | Tobramycin + Fluorometholone | NA | NA | ≥ 2 yrs | - | - |
Antibacterial + Steroid + Decongestant | Neomycin + Gramicidin + Tetryzoline + Dexamethasone | ≥ 3 yrs | NA | NA | - | - |
|  | Betamethasone + Sulphacetamide + Tetryzoline | ≥ 2 yrs | NA | NA | - | - |
MYDRIATIC/CYCLOPLEGIC MEDICATIONS | Â | 7/4 | 6/5 | 2/1 | 55 | 3 |
Antimuscarinic agent | Cyclopentolate | ≥ 3 yrs | > 3 ms | all | 14 | - |
| Â | Homatropine | ns | > 3 ms | nl | - | - |
| Â | Tropicamide | > 1 m | all | NA | 10 | - |
| Â | Atropine | ns | > 3 ms (nl uveitis) | NA | 31 | 3 |
| Â | Ibopamine | all | NA | NA | - | - |
Decongestant (Sympathomimetic agent) | Phenylephrine | ≥ 12 yrs | All (nl 10% drops) | NA | 2 | - |
PERI-OPERATIVE MEDICATIONS | Â | 2/0 | 4/4 | 1/0 | 4 | 0 |
Local anaesthetic | Lidocaine | nl | all | nl | 2 | - |
| Â | Oxybuprocaine | ns | all | NA | 1 | - |
| Â | Proxymetacaine | NA | all | NA | - | - |
| Â | Tetracaine | NA | all | NA | 1 | - |
LUBRICANTS AND ASTRIGENTS | Â | 5/0 | 10/5 | 4/0 | 0 | 0 |
Ocular lubricant and astringent | Polyvinyl alcohol | Ns | all | NA | - | - |
| Â | Carmellose sodium | ns | all | NA | - | - |
| Â | Hydroxyethylcellulose | NA | all | NA | - | - |
| Â | Paraffin | NA | all | NA | - | - |
| Â | Sodium hyaluronate | ns | all | NA | - | - |
| Â | Hypromellose | NA | all | nl | - | - |
LUBRICANT COMBINATIONS | Â | 0/0 | 2/2 | 6/2 | 0 | 0 |
Lubricants | Hypromellose + Glycerin | NA | NA | all | - | - |
| Â | Hypromellose + Dextran 70 | NA | all | nl | - | - |
|  | Hypromellose + Glycerin + Polyethylene glycol 400 | NA | NA | ≥ 6 yrs | - | - |
Lubricant + Steroid agent | Hypromellose + Dexamethasone | NA | all | NA | - | - |
OTHER OCULAR MEDICATIONS | Â | 2/1 | 2/2 | 2/1 | 0 | 0 |
Hypertonic agent | Sodium chloride | NA | all | Nl | - | - |
Ocular diagnostic agent | Fluorescein | ns | all | NA | - | - |
Topical immunomodulator | Cyclosporine 0.05% | NA | NA | ≥ 16 yrs | - | - |
Other ocular agent | Heparin | > 1 m | NA | NA | - | - |
TOTAL SINGLE DRUGS | 68 | 88/43 | 61/39 | 41/22 | 140 | 20 |
TOTAL COMBINATIONS | 29 | 16/7 | 10/6 | 14/7 | 4 | - |