Randomised controlled trial

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 2015;9:877-884.

What it found

Neither primary endpoint (ocular discomfort and inferior corneal staining at day 29) differed from placebo. Some secondary measures, such as discomfort during the day-28 challenge and central corneal staining, were better with Tβ4. No adverse events were reported.

Limitations

Missed its primary endpoints; positive findings are secondary. Single centre. Full protein as eye drops.

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