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Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Topical treatments compared with control for blepharokeratoconjunctivitis in children

Patient or population: children with blepharokeratoconjunctivitis

Settings: eye clinic

Intervention: topical treatments (antibiotics and/or steroids)

Comparison: placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Certainty (quality) of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

placebo (vehicle)

topical treatments (antibiotics/steroids)

Improvement in symptoms, reported by the child or by their parents/carers, preferably measured by a validated tool, at three months (± one month) after start of treatment

137

(1)

⊕⊝⊝⊝
very low1

Data on changes in grade of blepharoconjunctivitis measured between baseline and 2 weeks did not suggest any important differences between groups.

Elimination of all clinical signs of ocular surface inflammation ('complete success'), preferably measured by a composite grading system, at three months (± one month) after start of treatment

Not reported

Improvement of clinical signs of ocular surface inflammation ('partial success'), preferably measured by a composite grading system, at three months (± one month) after start of treatment

137

(10

⊕⊝⊝⊝
very low1

Data on changes in grade of blepharoconjunctivitis measured between baseline and 2 weeks did not suggest any important differences between groups.

Change from baseline in best corrected visual acuity in affected eye(s) in logMAR measured with an ETDRS chart at 4 m, or, in younger children, with a Keeler crowded logMAR chart at 3 m, at three months (± one month) after start of treatment

137

(1)

⊕⊝⊝⊝
very low2

Limited data in a form that could not be extracted; not statistically significant differences between groups.

Uncontrolled or poorly controlled disease progression due to treatment failure, at three months (± one month) after start of treatment

Adverse effects of medication, at any time during treatment

Ocular adverse events

  • Loteprednol/tobramycin 1/34 (eye pain)

  • Loteprednol 4/35 (eye pain, conjunctivitis, eye discharge, eye inflammation)

  • Tobramycin 0/34

  • Vehicle 0/34

Non‐ocular adverse events

  • Loteprednol/tobramycin 3 in 2/34 people (gastroenteritis, pyrexia, bronchiolitis)

  • Loteprednol 9 in 6/35 people (ear infection, lip swelling, vomiting, URI, varicella, cough, phyarngolaryngeal pain, rash)

  • Tobramycin 9 in 6/34 people (ear infection, otitis media acute, diarrhea, pyrexia, bronchioltis, URI, nasophayngitis, respirator distress, dermatitis (diaper) )

  • Vehicle 7 in 5/33 people (ear pain, pyrexia, urticaria, bronchioloitis, URI, tonsilitis, dehydration)

137

(1)

⊕⊝⊝⊝
very low3

Quality of life

Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk Ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Some data on blepharoconjunctivitis grade reported on trials registry but we were unable to estimate a measure of effect for this outcome.

2 Data were not fully reported and we were unable to estimate a measure of effect for change in visual acuity.

3 Very low certainty due to very low numbers of events.

Figures and Tables -
Table 1. Studies of blepharokeratoconjunctivitis treatment in children

Author, year

Study type

N

Age

Mean/median follow‐up

Mechanical treatment

Systemic (oral) interventions

Topical interventions

Physician‐reported outcomes

Patient‐reported outcomes

Adverse events from condition

Adverse events from treatment

Cehajic‐Kapetanovic 2010

Case series

7

6 to 14 years

6 months

Lid hygiene

Amoxicillin/ clavulanate

Chloramphenicol (PF) drops, chloramphenicol ointment to lids, prednisolone 0.5% (PF)

Eyelid condition, corneal epitheliopathy, stromal defects

Improvement of symptoms

None

None

Choi 2013

Case series

3

30 months to 8 years

Variable

Lid hygiene

Azithromycin

Loteprednol 0.2%, CSA 0.05%,

Chalazia, keratitis, corneal ulcer/scar, phlyctenule, MGD

Improvement of itching

None

None

Doan 2013

Case series

16

4 to 16 years

Variable

Lid hygiene

Erythromycin (1 participant only)

Azithromycin 1.5%, CSA 2%

Bulbar conjunctival hyperaemia, conjunctival phlycten, corneal inflammation, blepharitis grade

Ocular redness

None

Ocular irritation (redness, burning, stinging)

Farpour 2001

Case series

8

3.5 to 13 years

8.3 months

Lid hygiene

Erythromycin suspension 450 mg divided into 3 doses

Prednisolone 0.5% (PF); hydrocortisone acetate 1% ointment nocte

Bulbar conjunctival redness, inferior superficial corneal vascularisation, punctate corneal epithelial staining, inferior subepithelial vascularisation and infiltrate, conjunctival phlyctenules, corneal phlyctenules, circumferential pannus, corneal scar

Red eyes, photophobia, itching, discharge

Corneal scarring and thinning

Stomach disturbance, diarrhoea

Gupta 2010

Case series

615

7 months to 16 years

Not reported

Lid hygiene

Erythromycin

Topical steroids and antibiotics (not specified)

Outcomes not reported (presenting signs only)

Outcomes not reported (presenting symptoms only)

None

None

Hamada 2012

Case series

10

6 to 27 years

4.4 years

Lid hygiene

Azathioprine, mycophenolate mofetil, prednisolone

Steroids (not specified)

Disease remission/ control of inflammation

None

Corneal perforation

none

Hammersmith 2005

Case series

29

2 to 12 years

5.4 months

Warm compresses

Erythromycin, doxycyclin

Prednisolone 1%, dexamethasone 0.1%, antibiotic, fluorometholone, loteprednol etabonate 0.5%

Eyelid inflammation, superficial punctate keratitis, corneal vascularisation, corneal infiltrates, phlyctenules, corneal scarring

None

Amblyopia

Gastrointestinal distress, mouth ulcers (unrelated)

Jones 2007

Case series

27

7 months to 15.9 years

2.3 years

Warm compresses, lid hygiene

Erythromycin, doxycyclin, flaxseed oil

chloramphenicol, ciprofloxacin, gentamicin, prednisolone 1% or 0.5%, fluorometholone 0.1%

Visual acuity, astigmatism

Discomfort, photophobia

Amblyopia

Vaginal candidiasis

Meisler 2000

Case series

5

4 to 9 years

Not specified

Erythromycin

Lid hyperaemia and swelling, corneal infiltrates

None

None

None

Rodríguez‐Garcia 2016

Case series

114

Mean 9.3 years (± 4.2)

26.4 months

Lid hygiene

Flaxseed oil, erythromycin

Lubricants (hyaluronate, methylcellulose), erythromycin, ciprofloxacin, steroids (dexamethasone 0.1% (PF), loteprednol 0.5%, fluorometholone 0.1%), CSA 0.05%

Visual acuity

None

None reported

None reported

Teo 2012

Case series

51

Mean 10.2 years (± 3.6)

58.9 months

Warm compresses, lid hygiene

Antibiotics (erythromycin, amoxicillin/ clavulanate, doxycycline), steroids

Steroids (dexamethasone 1%, prednisolone 0.12 to 1%, fluorometholone 0.1%) , antibiotics (fucidic acid, levofloxacin, tobramycin), CSA 0.5%

Visual acuity

Redness, tearing, blurred vision, pain, irritation, photophobia, white spot, swelling, discharge, itching, rubbing

Corneal perforation

Raised intraocular pressure, cataract, gastrointestinal disturbance

Viswalingam 2005

Case series

44

1 to 14 years

7 years

Lid hygiene

Erythromycin

Chloramphenicol, steroids

Reduction of clinical signs

Redness, watering, itching, grittiness, discharge, photophobia, pain

None reported

None reported

Abbreviations:

CSA: ciclosporin
MGD: meibomian gland dysfunction
N: number of participants
PF: preservative‐free

Figures and Tables -
Table 1. Studies of blepharokeratoconjunctivitis treatment in children
Table 2. Randomised controlled trials of blepharokeratoconjunctivitis that included children

Author, year

Study type

N

Age

Mean/median follow‐up

Mechanical treatment

Systemic (oral) interventions

Topical interventions

Physician‐reported outcomes

Patient‐reported outcomes

Adverse events from condition

Adverse events from treatment

Comstock 2012

RCT

137

0 to 6 years

15 days

None

None

Loteprednol 0.5% , tobramycin 0.3%

Visual acuity

None

None

Eye pain, conjunctivitis, eye discharge, and eye inflammation

Hosseini 2013

RCT

Total 417; 19 children

Not specified

15 days

None

None

Azithromycin 1%, dexamethasone 0.1%

Complete bacterial eradication from conjunctiva and eyelids, complete resolution of clinical signs

Complete resolution of symptoms

None

Eye disorder, reduced visual acuity, punctate keratitis, blurred vision, conjunctival oedema, discharge, lid oedema, irritation, pain, itching

Shulman 1982

RCT

Total 71; number of children not specified

10 to 86 years

14 to 15 days

None

None

Gentamycin 0.3%, betamethasone 0.1%

Ocular sign score, specific ocular inflammatory signs, bacterial eradication

None

None

Conjunctival hyperaemia

Abbreviations:

N: number of participants
RCT: randomised controlled trial

Figures and Tables -
Table 2. Randomised controlled trials of blepharokeratoconjunctivitis that included children
Table 3. Blepharoconjunctivitis grade

Follow‐up

Loteprednol Etabonate and Tobramycin

Loteprednol Etabonate

Tobramycin

Vehicle

Mean (SD) N

Mean (SD) N

Mean (SD) N

Mean (SD) N

Day 3

‐7.32 (3.27) 34

‐7.74 (3.90) 34

‐5.94 (4.00) 32

‐6.58 (3.46) 31

Day 7

‐11.03 (3.20) 34

‐10.94 (4.69) 34

‐9.90 (3.80) 30

‐10.03 (4.63) 30

Day 15

‐11.41 (3.29) 34

‐11.23 (3.98) 35

‐10.68 (4.71) 34

‐10.30 (5.19) 33

Figures and Tables -
Table 3. Blepharoconjunctivitis grade
Table 4. Adverse events seen in each study group

Loteprednol/tobramycin

Loteprednol

Tobramycin

Vehicle

Ocular AEs

1/34 (eye pain)

4/35 (eye pain, conjunctivitis, eye discharge, eye inflammation)

0/34

0/33

Non‐Ocular AEs

2/34 3 AEs (gastroenteritis, pyrexia, bronchiolitis)

6/35 9 AEs (ear infection, lip swelling, vomiting, URI, varicella, cough, phyarngolaryngeal pain, rash)

6/34 9 AEs (ear infection, otitis media acute, diarrhea, pyrexia, bronchioltis, URI, nasophayngitis, respirator distress, dermatitis (diaper) )

5/33 7 AEs (ear pain, pyrexia, urticaria, bronchioloitis, URI, tonsilitis, dehydration)

Abbreviations:

AEs: adverse events

Figures and Tables -
Table 4. Adverse events seen in each study group