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. Author manuscript; available in PMC: 2025 Mar 1.
Published in final edited form as: Surv Ophthalmol. 2023 Nov 8;69(2):211–223. doi: 10.1016/j.survophthal.2023.11.002

Table 2.

Clinical studies on the effect of povidone-iodine on the treatment of conjunctivitis (VPVP-I: povidone-iodine; QID: 4 times/day; TID: 3 times/day; qPCR: quantitative polymerase chain reaction; CC-IFA: cell culture with confirmatory immunofluorescence; IOP: intraocular pressure; SEI: subepithelial infiltrates; n = number of patients; TEAEs: treatment-emergent adverse events; SD: standard deviation; AT: artificial tears)

Author/Year Disease Design Population Management Outcomes Comments
Isenberg et al. 2002 Acute conjunctivitis Double-masked, controlled, prospective clinical trial 459 children (mean age 6.6 ± 6.6 years; range, 7 months–21 years)

  • 1.25% PVP-I, QID, 1-2 weeks (230 patients)

    vs.

  • Neomycin–polymyxin-B-gramicidin (229 patients)

  • 1.25% PVP-I was as effective as antibiotics for treating bacterial conjunctivitis and marginally more effective against chlamydia.

  • Both were ineffective against viral conjunctivitis.

  • Most cultured organism: Heamophilus sp. (35), Moraxella sp. (21), S. aureus (18), S. pneumonia (15).

  • The mean number of days until cure was similar for PVI-treated eyes (9.4) and antibiotic-treated eyes (9.1).

  • Chlamydia took longer to cure than either viral or bacterial infections regardless of treatment group.

  • There were no statistically significant age or gender differences between the two groups.

  • PVP-I should be strongly considered as a treatment for bacterial and chlamydial conjunctivitis.
Pelletier et al. 2009 Adenoviral conjunctivitis Prospective, open-label, single-armed, descriptive phase II clinical study 6 patients (9 eyes) Combined PVP-I 0.4% / dexamethasone 0.1%, QID, minimum of 5 days

  • In 8/9 eyes, clinical resolution was observed by day 3 or 4.

  • In 6/6 eyes with detectable adenovirus by qPCR, clinical reduction in viral titer was seen by day 3, 4, or 5.

  • In 5/6 eyes with infectious virus confirmed by CC-IFA, elimination of infectivity was seen by day 4 or 5.

 No adverse effects related to PVP-I were seen.
Trinavarat et al. 2012 Epidemic keratoconjunctivitis Prospective, interventional, uncontrolled 61 patients PVP-I 2%, QID, for 1 week

  • The recovery rate within a week of treatment was 77%.

  • 28 (45.9%) recovered within a week after the onset.

  • EKC occurred bilaterally in 40 (66%).

  • The mean time elapsed before treatment was 2.1 ± 1.46 days.

  • Application of PVP-I was sustained until recovery or completing a 7-day trial in 78.7%.

  • No severe adverse effects have been reported.
Pinto et al. 2014 Presumed viral Conjunctivitis Randomized, masked, and controlled trial 122 patients

  • Topical dexamethasone 0.1%/PVP-I 0.4%, QID, 1 week (61 patients)

    vs.

  • Artificial tears, QID, 1 week (61 patients)

 Shorter conjunctivitis duration (9.4 ± 4.6 d) in treatment group versus 11.8 ± 4.9 d in the control group.

  • There was no statistically significant difference between groups in terms of symptoms and incidence of SEI.

  • More stinging was reported in the treatment group.
Tunay et al. 2014 Adenoviral conjunctivitis Prospective, randomized, controlled 35 infants (35 eyes) Mean age 3.1 months

  • Conjunctiva irrigated with PVP-I 2.5% then lubrication and netilmicin 0.3% drops QID (15 eyes)

    vs

  • Lubrications and netilmicin drops without PVP-I irrigation (20 eyes)

 The median recovery time was earlier in Group 1 (7 d) than Group 2 (12 d).

  • No relation was found between gender and clinical scores (lid edema, chemosis, fragility of conjunctival vasculature, and pseudomembrane formation).

  • Significant lower clinical scores were observed from Group 1.
Yazar et al. 2016 Adenoviral conjunctivitis Retrospective 112 patients

  • PVP-I solution: 1 mL of Tears Naturale + 1 mL 0.5% PVP-I , 3 drops TID, 2 weeks (56 patients)

    vs

  • •xsTrifluorothymidine (TFT) 3 drops TID, 2 weeks (56 patients)

  • 54 (96.4%) who received PVP-I drops recovered in two weeks, while 2 (3.6%) had late recovery time.

  • 33 (58.9%) of the control group recovered in two weeks while 23 (41.1%) took more time.

  • Overall, 92 (82.1%) patients had intra-familial transmission.
Kovalyuk et al. 2017 Adenoviral keratoconjunctivitis Prospective, randomized, controlled, double-blinded clinical trial 78 eyes (26 eyes in each group)

  • PVP-I 1.0% and dexamethasone 0.1%

    vs

  • Dexamethasone 0.1%

    vs

  • Lubricating eyedrops (hypromellose 0.3%)

  • The fastest improvement in patients red eyes, discharge, superficial punctate keratitis and pseudomembranes was observed in the study group.

  • Study group reached a near complete recovery in 5–7 days (confirmed by PCR).

  • The slowest improvement was in the control 2 group.

  • The rate of reduction in Adenovirus titers was the slowest in the control 1 group.

  • Adenovirus type 8 was the most common pathogen (83%).

  • SEI were observed in 44% of the control 1 group, 20% of the control 2 group and in 0% of the study group.
Pepose et al. 2018 Adenoviral conjunctivitis Multicenter, randomized, vehicle-controlled, double-masked phase 2 trial 176 patients

  • PVP-I 0.6%/dexamethasone 0.1% (48 patients)

    vs

  • PVP-I 0.6% (50 patients)

    vs

  • Vehicle (46 patients)

  • The proportion of clinical resolution at day 6 was higher with PVP-I/dexamethasone (31.3%) than with vehicle (10.9%) and PVP-I (18.0%).

  • The proportion with adenoviral eradication was higher with PVP-I/dexamethasone than with vehicle at day 3 (35.4% vs 8.7%;) and day 6 (79.2% vs 56.5%) and vs PVP-I (day 3, 32.0%; day 6, 62.0%).

  • Adverse effects occurred in 69.0% (vehicle), 62.7% (PVP-I), and 53.4% (PVP-I / dexamethasone).

  • Most frequent adverse effects were SEI, punctate keratitis, eyelid edema, and conjunctivitis.

  • Discontinuation due to adverse effects occurred in 37 patients (vehicle, n = 16; PVP-I, n = 12; PVP-I/dexamethasone, n = 9).
Altan-Yaycioglu et al. 2019 SEI in adenoviral keratoconjunctivitis Retrospective 211 patients

  • 102 patients received 2% PVP-I, BID, 5 days

  • Antibiotics in 93.4%, artificial tears in 88.2%, PVP-I 2% in 48.3%, corticosteroids in 20.3%, ganciclovir in 10.9%, and NSAID in 5.2%.

  • SEI developed in 33.3% of patients who received PVP-I 2% and in 45.9%, in patients who did not.

  • Mean age 33.03±14.76 years

  • Clinical signs were conjunctival hyperemia (100%), conjunctival follicles (79.1%), eyelids edema (39.3%), chemosis (16.1%), pseudomembrane (16.6%), and corneal epitheliopathy (29.9%).

  • In total, 13.3% developed conjunctival subepithelial fibrosis, and 39.8% developed SEI.
Pepose et al. 2019 Acute viral conjunctivitis Randomized, double-masked, parallel-group, vehicle-controlled study 132 patients

  • PVP-I 0.6%/DEX 0.1% ophthalmic suspension, QID, 5 days (66 patients)

    vs

  • Vehicle, QID, 5 days (66 patients)

  • There were no TEAEs

  • In the masked phase, 56.1% of the PVP-I/DEX group experienced at least one TEAE vs 43.9% in the vehicle group

  • 78.9% in the open-label phase experienced at least one TEAE.

  • Most TEAEs were mild.

  • 38 patients continued into the open-label portion of the study.

  • PVP-I/DEX administered for ≤14 days had a favorable safety profile and was well tolerated
Shorter el al. 2019 Adenoviral conjunctivitis Double-masked randomized trial 56 patients

  • One-time ophthalmic 5% PVP-I vs

  • Preservative-free AT

  • There was no change in VA between baseline and day 1 in either group.

  • In the 5% PVP-I group, there was no change in overall discomfort immediately post-administration or on day 1 compared to baseline.

  • In the AT group, overall discomfort was lower immediately post-administration but returned to baseline levels by Day 1.

  • In the PVP-I group, corneal staining increased immediately post-administration but returned to baseline levels by Day 1.
Ta et al. 2020 Acute bacterial conjunctivitis Prospective, randomized, double-masked, multicenter, phase 3 clinical trial 753 patients

  • PVI/DEX (n = 324)

  • PVP-I (n = 108)

  • Placebo (n = 321)

  • At the day 5 visit, clinical resolution was achieved by 50.5% (111/220) in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group, and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively.

  • Adverse effects were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity).

  • The modified ITT population for the efficacy analysis comprised 526 subjects.

  • Mean and SD age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%).
Than et al. 2021 Adenoviral Conjunctivitis Double-masked pilot randomized trial 56 patients

  • Group 1: 5% PVP-I once (n=30)

  • Group 2: AT (n=26)

  • Day 4, viral titers in the 5% PVP-I and AT groups were 2.5% ± 2.7% and 14.4% ± 10.5% of peak respectively.

  • Severity of participant-reported tearing, lid swelling and redness as well as clinician-graded mucoid discharge, bulbar redness and bulbar edema was lower in the 5% PVP-I group than AT group on day 4.

  • After day 4, viral titers, severity of signs and symptoms decreased markedly in both groups and no differences between groups were detected.