From: Ocular medicines in children: the regulatory situation related to clinical research
Pharmaco-therapeutic Group | Drug name | Formulation | N° RCTs | N° Children | Age range |
---|---|---|---|---|---|
MYDRIATIC/CYCLOPLEGIC MEDICATIONS | Â | 74 (35%) | Â | Â | |
Antimuscarinic agent | Atropine | eye drops 1% | 31 | 3530 | all |
 | Cyclopentolate | eye drops 0.5% | 2 | 28 | ≤ 13 yrs |
 |  | eye drops 1% | 11 | 181 | ≤ 16 yrs |
 | Tropicamide | eye drops 1% | 9 | 348 | all |
 | Pirenzepine | ophthalmic gel 1% | 3 | 276 | 6 - 12 yrs |
 | Cyclopentolate/Tropicamide | eye drops 1%/1% | 6 | 176 | all |
Sympathomimetic agent | Phenylephrine | eye drops 2.5% | 1 | 10 | ≤ 1 m |
Antimuscarinic agent + Sympathomimetic agent | Tropicamide/Phenylephrine | eye drops 1%/2.5% | 3 | 92 | ≤ 1 m |
 |  | eye drops 0.5%/2.5% | 2 | 51 | ≤ 8 yrs |
 |  | eye drops 0.5%/0.5% | 1 | 12 | 3-11 yrs |
 | Cyclopentolate/Phenylephrine | eye drops 1%/2.5% | 2 | 30 | ≤ 6 yrs |
 |  | eye drops 0.2%/1% | 3 | 99 | ≤ 1 m |
ANTI-INFECTIVE MEDICATIO NS | Â | 51 (24%) | Â | Â | |
Antibacterial agent | Chloramphenicol | eye drops 0.5% | 7 | 1664 | ≤ 12 yrs |
 | Azithromycin | eye drops 1% | 1 | 335 | ≥ 1 yr |
 |  | eye drops 1.5% | 2 | 542 | ≥ 1 yr |
 | Tetracycline | eye drops 1% | 2 | 518 | 1- 10 yrs |
 |  | eye ointment 1% | 2 | 218 | ≥ 6 ms |
 | Besifloxacin | eye suspension 0.6% | 3 | 1124 | ≥ 1yr |
 | Fusidic acid | eye drops 1% | 3 | 594 | ≤ 2 yrs |
 | Moxifloxacin | eye drops 0.5% | 3 | 645 | all |
 | Tobramycin | eye drops | 3 | 741 | ≤ 12 yrs |
 | Ciprofloxacin | eye drops 0.3% | 2 | 193 | ≤ 12 yrs |
 | Levofloxacin | eye drops 0.5% | 2 | 106 | 1-16 yrs |
 | Gentamycin | eye ointment | 2 | 117 | ≤ 12 yrs |
 | Erythromycin | eye drops | 1 | 110 | ≤ 1 m |
 |  | eye ointment | 1 | 24 | ≤ 1 yr |
 | Ofloxacin | eye drops 0.3% | 1 | 23 | ≥2 yrs |
 | Oxytetracycline | eye drops 1% | 1 | 450 | ≤ 1 m |
 | Sulphacetamide | eye drops 10% | 1 | 14 | ≤ 1 m |
Antibacterials combinations | Polymixin B/Oxytetracycline | eye ointment | 2 | 132 | 2-10 yrs |
 | Polymixin B/Bacitracin | eye ointment | 1 | 66 | ≥ 1 m |
 | Polymixin B/Trimethoprim | eye drops | 1 | 28 | all |
Antibacterial agent + NSAID | Gentamycin/Diclofenac | eye drops | 1 | 12 | ≤ 12 yrs |
Antibacterial agent + Steroid agent | Neomycin/Betamethasone | eye drops | 1 | 12 | ≤ 12 yrs |
 | Tobramycin/Dexamethasone | eye drops | 1 | 28 | 4-10 yrs |
Antifungal agents | Miconazole | eye suspension 1% | 1 | 12 | ≥ 15 yr |
 | Econazole/Miconazole | eye suspension 1%/1% | 1 | 7 | ≥ 15 yr |
Other anti-infective eye preparation | Povidone-iodine | eye drops 2.5% | 4 | 3132 | ≤ 1 yr |
 | Silver nitrate | eye drops 1% | 1 | 450 | ≤ 1 m |
ANTI-ALLERGY MEDICATIONS | Â | 31 (15%) | Â | Â | |
Anti-histamine agent | Levocabastine | eye suspension 0.5% | 6 | 174 | ≥ 3 yrs |
 | Ketotifen | eye drops 0.025% | 5 | 522 | ≥ 3 yrs |
 | Olopatadine | eye drops 0.2% | 4 | 99 | ≥ 3 yrs |
 | Azelastine | eye drops 0.02% | 4 | 132 | ≥ 4 yrs |
 | Bepotastine | eye drops 1% | 1 | 36 | ≥ 10 yrs |
 |  | eye drops 1.5% | 1 | 36 | ≥ 10 yrs |
 | Emedastine | eye drops 0.05% | 1 | - | 3-16 yrs |
Mast cell stabilizer | Lodoxamide | eye drops 0.1% | 1 | 15 | ≥ 6 yrs |
 | Cromoglycate | eye drops 2% | 4 | 128 | ≥ 4 yrs |
 |  | eye drops 4% | 1 | 30 | ≥ 16 yrs |
 | Nedocromil | eye drops 2% | 3 | 85 | ≥ 4 yrs |
ANTI-INFLAMMATORY MEDICATIONS | Â | 18 (9%) | Â | Â | |
Corticosteroid | Dexamethasone | eye drops 0.1% | 6 | 159 | all |
 | Fluorometholone | eye drops 0.1% | 3 | 52 | ≤ 10 yrs |
 | Rimexolone | eye drops 1% | 1 | 22 | 4 - 8 yrs |
NSAID | Diclofenac | eye drops 0.1% | 4 | 93 | ≥ 2 yrs |
 | Ketorolac | eye drops 0.5% | 3 | 70 | ≤ 12 yrs |
 | Flurbiprofen | eye drops | 1 | 50 | ≥ 5 yrs |
ANTIGLAUCOMA MEDICATIONS | Â | 10 (5%) | Â | Â | |
Beta-blocker | Timolol | eye drops 0.25% | 2 | 44 | 7-13 yrs |
 |  | eye drops 0.5% | 1 | 12 | ≥ 14 yrs |
 |  | gel-forming solution 0.25% | 1 | 35 | ≤ 6yrs |
 |  | gel-forming solution 0.5% | 1 | 36 | ≤ 6yrs |
 | Betaxolol | eye suspension 0.25% | 1 | 52 | ≤ 6 yrs |
 | Levobetaxolol | eye suspension 0.5% | 1 | 46 | ≤ 6 yrs |
Carbonic anhydrase inhibitor | Brinzolamide | eye suspension 1% | 1 | 32 | ≤ 6 yrs |
 | Dorzolamide | eye drops 2% | 1 | 56 | ≤ 6 yrs |
Acetylcholinesterase inhibitor | Echothophate iodide | eye drops | 1 | 20 | - |
PERI-OPERATIVE MEDICATIONS | Â | 18 (9%) | Â | Â | |
Local anaesthetic agent | Bupivacaine | subconjuntival infiltration | 2 | 38 | 5-10 yrs |
 |  | eye drops 0.5% | 1 | 17 | 3-6 yrs |
 | Proparacaine | eye drops 0.5% | 3 | 58 | ≤ 1 m |
 | Lidocaine | eye drops 2% | 1 | 10 | 3 - 14 yrs |
 |  | ophthalmic gel 2% | 1 | 24 | 3-12 yrs |
 | Amethocaine | eye drops 0.5% | 2 | 45 | 2 - 8 yrs |
 | Levobupivacaine | eye drops | 1 | 13 | 1 - 16 yrs |
 | Oxybuprocaine | eye drops 0.4% | 1 | 20 | 3-8 yrs |
 | Tetracaine | eye drops 1% | 1 | 44 | 1-12 yrs |
 | Sucrose | eye drops | 1 | 11 | ≤1 m |
Chemotherapeutic agents | Mitomicyn C | eye drops 0.02% | 1 | 10 | ≥ 6 yrs |
 |  | ocular injection 0.4% | 1 | 7 | ≥ 6 yrs |
 | 5-fluorouracil | ocular injection | 1 | 4 | ≤ 12 yrs |
 | Mitomicyn C/5-fluorouracil | ocular injection | 1 | 4 | ≤ 12 yrs |
OTHER DRUGS | Â | 7 (3%) | Â | Â | |
Vernal keratoconjunctivitis | Cyclosporine | eye drops 2% | 1 | 14 | 5-16 yrs |
 |  | eye drops 1.25% | 1 | 20 | 5-14 yrs |
 |  | eye drops 1% | 1 | 32 | 5-14 yrs |
 | Mipragoside | ophthalmic gel 0.5% | 1 | 12 | 5-20 yrs |
ROP therapy | Bevacizumab | intravitreal injection | 1 | 7 | ≤ 1 m |
Esotropia | Botulinum toxin | ocular injection | 1 | 27 | 6-12 yrs |
Dacryocystitis | Herba houttuyaniae | eye drops | 1 | 268 | ≤ 1 m |
TOTAL (69 single drugs & combinations) | Â | Â | 209 | 18,816 | Â |