NCT02199964

Brief Summary

This study will test that hypothesis that topical administration of the FDA approved immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface disease that results from a short term low humidity environmental stress

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

July 16, 2014

Results QC Date

February 21, 2017

Last Update Submit

February 12, 2020

Conditions

Dry Eye

Keywords

Dry eyeenvironmental stressartificial tearscyclosporinRestasis

Outcome Measures

Primary Outcomes (1)

  • Corneal Fluorescein Staining

    The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42

    6 weeks

Secondary Outcomes (1)

  • Eye Irritation Symptoms

    6 weeks

Other Outcomes (1)

  • Conjunctival Goblet Cells

    6 weeks

Study Arms (2)

Cyclosporin 0.05% emulsion

EXPERIMENTAL

used in the eye 4 times a day

Drug: Cyclosporin 0.05% emulsion

Endura Refresh, Artificial Tears

ACTIVE COMPARATOR

Over the Counter artificial tears used in the eye 4 times a day

Drug: Endura, Refresh artificial tears

Interventions

Cyclosporin 0.05% emulsionDRUG

Topical therapy for dry eye

Also known as: Artificial tears, Cyclosporin 0.05% emulsion (Restasis), Dry Eyes
Cyclosporin 0.05% emulsion
Endura, Refresh artificial tearsDRUG

Over the counter therapy for dry eye, used 4 times a day

Also known as: Dry Eyes, Artificial Tears
Endura Refresh, Artificial Tears

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signature on the written informed consent form
  • Patient willingness and ability to return for all visits during the study
  • Rapid tear film break up time of seven seconds or less in at least one eye AND
  • Both cornea fluorescein staining score greater than or equal to 3 and conjunctival lissamine green staining greater than or equal to 3 in at least one eye
  • Ocular Surface Disease Index Symptom Severity score of twenty or greater
  • Tear meniscus height less than or equal to 230um
  • Intact corneal sensitivity
  • Willingness to discontinue use of any current dry eye treatment (except artificial tears) for four weeks prior to enrollment, and during the course of the study

You may not qualify if:

  • Compromised cognitive ability which may be expected to interfere with study compliance
  • Uncontrolled or poorly controlled diabetes or heart or pulmonary disease that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study
  • Known hypersensitivity to any components of the artificial tears or cyclosporin A eye drops Anticipated contact lens wear during the study
  • History of corneal transplant
  • Active ocular infection, uveitis or non-KCS related inflammation
  • History of cataract surgery within 3 months prior to enrollment
  • History of pterygium removal within 6 months prior to enrollment
  • Reduced corneal sensitivity
  • Initiation, discontinuation or change in dosage of hormone replacement therapy (HRT), fish oil, evening primrose, flaxseed, or black current seed oil supplements, antihistamines, cholinergic agents, beta-blocking agents, tricyclic or SSRI antidepressants, phenothiazines, or topical or systemic acne rosacea medications in two months prior to enrollment, or anticipated change in dosage during course of study
  • Topical ophthalmic medications within prior 4 weeks, or anticipated use of same during the study (except artificial tears)
  • Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal plugs within three months prior to study, or anticipated use of same during study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alkek Eye Center, Dept of Ophthalmology, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Alex A, Edwards A, Hays JD, Kerkstra M, Shih A, de Paiva CS, Pflugfelder SC. Factors predicting the ocular surface response to desiccating environmental stress. Invest Ophthalmol Vis Sci. 2013 May 7;54(5):3325-32. doi: 10.1167/iovs.12-11322.

    PMID: 23572103BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

CyclosporineEmulsionsLubricant Eye DropsCyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsColloidsComplex MixturesDosage FormsPharmaceutical PreparationsOphthalmic SolutionsPharmaceutical SolutionsSolutionsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Results Point of Contact

Title
Stephen Pflugfelder, M.D.
Organization
Baylor College of Medicine
stevenp@bcm.edu
713-798-6100

Study Officials

  • Stephen C. Pflugfelder, MD

    Baylor College of Medicine, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Ocular Surface Clinical Trials

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 25, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 20, 2020

Results First Posted

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

The study was terminated early because of loss of funding.

Locations

US(1)