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Study · Randomized controlled trial · n = 9 · 2015

4 results

Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial.

Sosne G, Dunn SP, Kim C

Cornea1 May 2015Cited by 41 (Europe PMC)

PMID25826322 (opens in a new tab)DOI10.1097/ico.0000000000000379 (opens in a new tab)PepBankPUB-25826322
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with severe dry eye, RGN-259 (thymosin β4 eye drops) reduced ocular discomfort by 35.1% versus vehicle at day 56.

    In plain wordsIn people with severe dry eye, thymosin β4 eye drops reduced eye discomfort more than vehicle drops.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    DecreaseOcular discomfort (OSDI) at day 56
    Study

    n = 9

    Comparator
    Vehicle control
    Outcome group
    Ocular surface · Eye
    Studied dose
    0.1% · eye drops · 28 daysAs given in this study (human).

    Measurements

    Reduction of ocular discomfort
    35.1%
    RGN-259 vs vehicle, day 56

    Source sentences

    Summary
    Of particular note at day 56, the RGN-259-treated group (12 eyes) had 35.1% reduction of ocular discomfort compared with vehicle control (6 eyes) (P = 0.0141), and 59.1% reduction of total corneal fluorescein staining compared with vehicle control (P = 0.0108).
    2 context sentences
    Summary · context
    A small, multicenter, randomized, double-masked, placebo-controlled 56-day phase 2 clinical trial including a 28-day follow-up at 2 US sites.
    Summary · context
    Nine patients with severe dry eye were treated with either RGN-259 (0.1%) or vehicle control 6 times daily over a period of 28 days.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with severe dry eye, RGN-259 reduced total corneal fluorescein staining by 59.1% versus vehicle at day 56.

    In plain wordsIn people with severe dry eye, thymosin β4 eye drops reduced damage to the eye surface more than vehicle drops.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    DecreaseTotal corneal fluorescein staining at day 56
    Study

    n = 9

    Comparator
    Vehicle control
    Outcome group
    Ocular surface · Eye
    Studied dose
    0.1% · eye drops · 28 daysAs given in this study (human).

    Measurements

    Reduction of total corneal fluorescein staining
    59.1%
    RGN-259 vs vehicle, day 56

    Source sentences

    Summary
    Of particular note at day 56, the RGN-259-treated group (12 eyes) had 35.1% reduction of ocular discomfort compared with vehicle control (6 eyes) (P = 0.0141), and 59.1% reduction of total corneal fluorescein staining compared with vehicle control (P = 0.0108).
    2 context sentences
    Summary · context
    A small, multicenter, randomized, double-masked, placebo-controlled 56-day phase 2 clinical trial including a 28-day follow-up at 2 US sites.
    Summary · context
    Nine patients with severe dry eye were treated with either RGN-259 (0.1%) or vehicle control 6 times daily over a period of 28 days.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with severe dry eye, RGN-259 treatment improved tear film breakup time.

    In plain wordsIn people with severe dry eye, thymosin β4 eye drops improved how long the tear film stays intact.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    IncreaseTear film breakup time
    Study

    n = 9

    Outcome group
    Ocular surface · Eye
    Studied dose
    0.1% · eye drops · 28 daysAs given in this study (human).

    Source sentences

    Summary
    Other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production.
    2 context sentences
    Summary · context
    A small, multicenter, randomized, double-masked, placebo-controlled 56-day phase 2 clinical trial including a 28-day follow-up at 2 US sites.
    Summary · context
    Nine patients with severe dry eye were treated with either RGN-259 (0.1%) or vehicle control 6 times daily over a period of 28 days.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with severe dry eye, RGN-259 treatment increased tear volume production.

    In plain wordsIn people with severe dry eye, thymosin β4 eye drops increased tear production.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    IncreaseTear volume production
    Study

    n = 9

    Outcome group
    Ocular surface · Eye
    Studied dose
    0.1% · eye drops · 28 daysAs given in this study (human).

    Source sentences

    Summary
    Other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production.
    2 context sentences
    Summary · context
    A small, multicenter, randomized, double-masked, placebo-controlled 56-day phase 2 clinical trial including a 28-day follow-up at 2 US sites.
    Summary · context
    Nine patients with severe dry eye were treated with either RGN-259 (0.1%) or vehicle control 6 times daily over a period of 28 days.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT01393132

Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye

Michigan Cornea Consultants, PCn = 9Mar 2011 to Dec 2012

Dry Eye · Sjogren's Syndrome · Graft vs. Host Disease

Trial pageClinicalTrials.govUpdated 23 Dec 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    13 Oct 2026, 01:52 UTC

    Study results updated

  2. Version 1

    12 Oct 2026, 18:17 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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