Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE) model

Sosne G, Ousler GW · Clinical Ophthalmology

Neither primary endpoint — ocular discomfort and inferior corneal staining at day 29 — differed significantly from placebo. Several secondary endpoints did: discomfort during the day-28 environmental challenge fell 27% (p=0.0244), with central and superior corneal staining improved (p=0.0075 and p=0.0210). No adverse events.

Population

Adults with moderate to severe dry eye, single centre

Intervention

0.1% Tβ4 ophthalmic solution for 28 days

Comparator

Placebo

Limitations

The paper's own conclusion ("confirms the efficacy") rests on secondary endpoints after both primaries were missed; single centre.