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Study · Randomized controlled trial · n = 72 · 2015

6 results

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 (Auckland, N.Z.)20 May 2015Cited by 40 (Europe PMC)

PMID26056426 (opens in a new tab)PMCIDPMC4445951 (opens in a new tab)DOI10.2147/opth.s80954 (opens in a new tab)PepBankPUB-26056426
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with moderate to severe dry eye, 0.1% Tβ4 did not differ significantly from placebo in ocular discomfort at visit 5.

    In plain wordsIn people with dry eye, Tβ4 eye drops did not differ from placebo in discomfort at visit 5.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    No significant changeOcular discomfort score at visit 5
    Study

    n = 72

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Pain · Eye
    Studied dose
    0.1% · topical ophthalmic · 28 daysAs given in this study (human).

    Source sentences

    Summary
    Neither of the primary endpoints, ie, ocular discomfort or inferior corneal staining, showed a significant difference between treatment and control groups at visit 5.
    1 context sentence
    Summary · context
    This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with moderate to severe dry eye, 0.1% Tβ4 did not differ significantly from placebo in inferior corneal staining at visit 5.

    In plain wordsIn people with dry eye, Tβ4 eye drops did not differ from placebo in corneal staining at visit 5.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    No significant changeInferior corneal staining at visit 5
    Study

    n = 72

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Wound healing · Eye
    Studied dose
    0.1% · topical ophthalmic · 28 daysAs given in this study (human).

    Source sentences

    Summary
    Neither of the primary endpoints, ie, ocular discomfort or inferior corneal staining, showed a significant difference between treatment and control groups at visit 5.
    1 context sentence
    Summary · context
    This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with dry eye, discomfort scores in the controlled adverse environment on day 28 were 27% lower with 0.1% Tβ4 than with placebo.

    In plain wordsIn people with dry eye, discomfort scores after the test chamber were 27% lower with Tβ4 than with placebo.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    DecreaseDiscomfort score in the CAE on day 28
    Study

    n = 72

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Pain · Eye
    Studied dose
    0.1% · topical ophthalmic · 28 daysAs given in this study (human).

    Measurements

    Discomfort score reduction
    27%
    0.1% Tβ4 vs placebo

    Source sentences

    Summary
    The discomfort scores in the CAE on day 28 were reduced by 27% in 0.1% Tβ4-treated subjects compared with the placebo group (P=0.0244).
    1 context sentence
    Summary · context
    This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with dry eye, 0.1% Tβ4 significantly improved central corneal staining versus placebo.

    In plain wordsIn people with dry eye, Tβ4 eye drops improved central corneal staining more than placebo.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    DecreaseCentral corneal staining
    Study

    n = 72

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Wound healing · Eye
    Studied dose
    0.1% · topical ophthalmic · 28 daysAs given in this study (human).

    Source sentences

    Summary
    Subjects in the 0.1% Tβ4 treatment group also showed statistically significant improvements in central and superior corneal staining compared with staining scores in the control group (P=0.0075 and P=0.0210).
    1 context sentence
    Summary · context
    This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with dry eye, 0.1% Tβ4 significantly improved superior corneal staining versus placebo.

    In plain wordsIn people with dry eye, Tβ4 eye drops improved superior corneal staining more than placebo.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    DecreaseSuperior corneal staining
    Study

    n = 72

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Wound healing · Eye
    Studied dose
    0.1% · topical ophthalmic · 28 daysAs given in this study (human).

    Source sentences

    Summary
    Subjects in the 0.1% Tβ4 treatment group also showed statistically significant improvements in central and superior corneal staining compared with staining scores in the control group (P=0.0075 and P=0.0210).
    1 context sentence
    Summary · context
    This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with dry eye, no adverse events were observed with 0.1% Tβ4.

    In plain wordsIn people with dry eye, no side effects were seen with Tβ4 eye drops.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    No significant changeAdverse events
    Study

    n = 72

    Comparator
    Placebo
    Outcome group
    Adverse events · Eye
    Studied dose
    0.1% · topical ophthalmic · 28 daysAs given in this study (human).

    Source sentences

    Summary
    No adverse events were observed.
    1 context sentence
    Summary · context
    This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days.

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

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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