Results from a Prospective, Open-Label, Phase 4 Pilot Study of Repository Corticotropin Injection for Moderate and Severe Dry Eye Disease.

Toyos M, Toyos R, Jodoin B, Bunch R

Ophthalmology and therapy23 Apr 2022Cited by 6 (Europe PMC)

PMID35460497PMCIDPMC9114278DOI10.1007/s40123-022-00501-2PepBankPUB-35460497

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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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanNon-randomized trialEfficacy outcome
In adults with dry eye disease, Acthar significantly reduced fluorescein-stained SPK lesions at day 14 versus baseline.
In plain wordsIn adults with dry eyes, Acthar reduced stained eye lesions compared with baseline at day 14.
Peptide
ACTH (corticotropin)
Outcome
DecreaseFluorescein-stained SPK lesions at day 14
Study
n = 12
Comparator
Baseline
Analysis
Primary
Outcome group
Eye surface disease · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
p
0.025
day 14 versus baseline
Source sentences
Summary
Compared to baseline (day 1), significantly fewer fluorescein-stained SPK lesions were detected at day 14 (p = 0.0250) and day 84 (p = 0.0240) after RCI treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049701
02HumanNon-randomized trialEfficacy outcome
In adults with dry eye disease, Acthar significantly reduced fluorescein-stained SPK lesions at day 84 versus baseline.
In plain wordsIn adults with dry eyes, Acthar reduced stained eye lesions compared with baseline at day 84.
Peptide
ACTH (corticotropin)
Outcome
DecreaseFluorescein-stained SPK lesions at day 84
Study
n = 12
Comparator
Baseline
Analysis
Primary
Outcome group
Eye surface disease · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
p
0.024
day 84 versus baseline
Source sentences
Summary
Compared to baseline (day 1), significantly fewer fluorescein-stained SPK lesions were detected at day 14 (p = 0.0250) and day 84 (p = 0.0240) after RCI treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049702
03HumanNon-randomized trialEfficacy outcome
In adults with dry eye disease, mean SANDE scores declined from 62.0 at baseline to 46.9 at day 84 with Acthar.
In plain wordsIn adults with dry eyes, symptom scores declined from baseline after Acthar.
Peptide
ACTH (corticotropin)
Outcome
DecreaseSANDE score
Study
n = 12
Comparator
Baseline
Analysis
Primary
Outcome group
Eye surface disease · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
SANDE
62 score
baseline
SANDE
46.9 score
day 84
Source sentences
Summary
Mean SANDE scores progressively declined from 62.0 at baseline to 46.9 at day 84.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049703
04HumanNon-randomized trialEfficacy outcome
In adults with dry eye disease, erythema significantly improved after 12 weeks of Acthar versus baseline.
In plain wordsIn adults with dry eyes, redness improved compared with baseline after Acthar.
Peptide
ACTH (corticotropin)
Outcome
DecreaseErythema
Study
n = 12
Comparator
Baseline
Analysis
Secondary
Outcome group
Eye surface disease · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
p
0.0046
erythema
Source sentences
Summary
Erythema (p = 0.0046), conjunctival lissamine green staining of SPK lesions (p = 0.0317), and IOP (p = 0.0052) were all significantly improved after 12 weeks of RCI therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049704
05HumanNon-randomized trialEfficacy outcome
In adults with dry eye disease, conjunctival lissamine green staining significantly improved after 12 weeks of Acthar versus baseline.
In plain wordsIn adults with dry eyes, conjunctival staining improved compared with baseline after Acthar.
Peptide
ACTH (corticotropin)
Outcome
DecreaseConjunctival lissamine green staining
Study
n = 12
Comparator
Baseline
Analysis
Secondary
Outcome group
Eye surface disease · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
p
0.0317
conjunctival staining
Source sentences
Summary
Erythema (p = 0.0046), conjunctival lissamine green staining of SPK lesions (p = 0.0317), and IOP (p = 0.0052) were all significantly improved after 12 weeks of RCI therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049705
06HumanNon-randomized trialEfficacy outcome
In adults with dry eye disease, intraocular pressure significantly improved after 12 weeks of Acthar versus baseline.
In plain wordsIn adults with dry eyes, eye pressure improved compared with baseline after Acthar.
Peptide
ACTH (corticotropin)
Outcome
Direction not reportedIntraocular pressure
Study
n = 12
Comparator
Baseline
Analysis
Secondary
Outcome group
Eye pressure · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
p
0.0052
IOP
Source sentences
Summary
Erythema (p = 0.0046), conjunctival lissamine green staining of SPK lesions (p = 0.0317), and IOP (p = 0.0052) were all significantly improved after 12 weeks of RCI therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049706
07HumanNon-randomized trialEfficacy outcome
In adults with dry eye disease, Schirmer's test scores showed no significant change from baseline during Acthar treatment.
In plain wordsIn adults with dry eyes, tear test scores did not change significantly from baseline during Acthar treatment.
Peptide
ACTH (corticotropin)
Outcome
No significant changeSchirmer's test score
Study
n = 12
Comparator
Baseline
Analysis
Secondary
Outcome group
Eye surface disease · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Schirmer's test scores and BCVA showed no significant changes throughout the study.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049707
08HumanNon-randomized trialEfficacy outcome
In adults with dry eye disease, BCVA showed no significant change from baseline during Acthar treatment.
In plain wordsIn adults with dry eyes, corrected vision did not change significantly from baseline during Acthar treatment.
Peptide
ACTH (corticotropin)
Outcome
No significant changeBest corrected visual acuity
Study
n = 12
Comparator
Baseline
Analysis
Secondary
Outcome group
Vision and retina · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Schirmer's test scores and BCVA showed no significant changes throughout the study.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049708
09HumanNon-randomized trialSafety outcome
In adults with dry eye disease, no ocular adverse events occurred during Acthar treatment.
In plain wordsIn adults with dry eyes, no eye adverse events occurred during Acthar treatment.
Peptide
ACTH (corticotropin)
Outcome
Not applicableOcular adverse events
Study
n = 15
Outcome group
Adverse events · Eye
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
No ocular AEs or deaths occurred, and no new safety signals were identified for RCI.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049709
10HumanNon-randomized trialSafety outcome
In adults with dry eye disease, no deaths occurred during Acthar treatment.
In plain wordsIn adults with dry eyes, no deaths occurred during Acthar treatment.
Peptide
ACTH (corticotropin)
Outcome
Not applicableDeaths
Study
n = 15
Outcome group
Mortality · Whole body
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
No ocular AEs or deaths occurred, and no new safety signals were identified for RCI.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049710
11HumanNon-randomized trialSafety outcome
In adults with dry eye disease, no new safety signals were identified for Acthar.
In plain wordsIn adults with dry eyes, investigators identified no new safety signals for Acthar.
Peptide
ACTH (corticotropin)
Outcome
Not applicableNew safety signals
Study
n = 15
Outcome group
Adverse events · Whole body
Studied dose
80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
No ocular AEs or deaths occurred, and no new safety signals were identified for RCI.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.
Report a problemFND-3546049711

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 4Results postedNCT03287635

Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease

Toyos Clinicn = 191 Jul 2018 to 4 Mar 2020

Dry Eye Disease

Trial page ClinicalTrials.govUpdated 28 Jan 2021

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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Keywords

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