NCT01072526

Brief Summary

The purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment of dry eye disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2007

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

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

January 12, 2017

Completed
Last Updated

January 12, 2017

Status Verified

November 1, 2016

Enrollment Period

2.7 years

First QC Date

December 31, 2007

Results QC Date

September 4, 2014

Last Update Submit

November 15, 2016

Conditions

Dry Eye Syndromes

Keywords

Dry Eye SyndromesLacrimal Apparatus Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in Ocular Surface Disease Index (OSDI)

    Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.

    Start of treatment, 6 weeks

Secondary Outcomes (3)

  • Change in Tear Film Breakup Time

    Baseline, 6 weeks

  • Change in Fluorescein Staining Scale

    Baseline, 6 weeks

  • Change in Schirmer Tear Test With Anesthesia Result

    Baseline, 6 weeks

Other Outcomes (1)

  • Change in Severity of Ocular Discomfort

    Baseline, 6 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .

Drug: Euphrasia-based homeopathic therapyDrug: Cyclosporin solution

Control

PLACEBO COMPARATOR

Subjects will receive placebo in combination with cyclosporin solution (Restasis) .

Drug: Cyclosporin solution

Interventions

Euphrasia-based homeopathic therapyDRUG

ophthalmic solution; 1 drop both eyes twice daily

Also known as: Artificial Tears
Intervention
Cyclosporin solutionDRUG

Cyclosporin solution; 1 drop both eyes twice daily

Also known as: Restasis
ControlIntervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of moderate to severe dry eye syndrome with or without Sjögren's syndrome
  • receiving treatment with topical cyclosporine (Restasis)
  • experience one or more moderate dry eye-related symptoms, including dryness, foreign body sensation, burning, blurred vision, photophobia, and soreness or pain

You may not qualify if:

  • history of ocular disorder including non-dry eye ocular inflammation, glaucoma, contact lens use
  • trauma or surgery, including punctal plug insertion within the prior 3 months
  • any uncontrolled systemic disease or significant illness
  • use of topical ophthalmic medications that could affect dry eye syndrome
  • pregnancy, lactation, or considering a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia, Mason Eye Institute

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesLacrimal Apparatus Diseases

Interventions

Lubricant Eye DropsCyclosporins

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of ChemicalsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

Title
Lenworth Johnson, MD
Organization
University of Missouri
JohnsonLN@health.missouri.edu
573-882-8473

Study Officials

  • Lenworth N Johnson, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2007

First Posted

February 22, 2010

Study Start

December 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 12, 2017

Results First Posted

January 12, 2017

Record last verified: 2016-11

Locations

US(1)