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Table 2 Summary of retrieved RCTs on the use of ocular medications in the paediatric population

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

 

74 (35%)

  

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

 

51 (24%)

  

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

 

31 (15%)

  

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

 

18 (9%)

  

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

 

10 (5%)

  

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

 

18 (9%)

  

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

 

7 (3%)

  

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)

  

209

18,816

 
  1. NOTE: the total is higher than the sum of the RCTs (158) because some drugs were tested in more than one trial. The references to RCTs are available upon request to the corresponding author.