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Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT01072526
Recruitment Status : Terminated (Study personnel left institution before study completion)
First Posted : February 22, 2010
Results First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye Syndromes
Interventions Drug: Euphrasia-based homeopathic therapy
Drug: Cyclosporin solution
Enrollment 7
Recruitment Details Study was conducted Dec 2007 to Sept 2008. Participants were evaluated in the Mason Eye Institute and underwent 4 measures of dry eyes at baseline and after 6 weeks of therapy.
Pre-assignment Details Participants will stop all common artificial tear use for 2 weeks prior to baseline examination and randomization.
Arm/Group Title Intervention Control
Hide Arm/Group Description Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI). Cyclosporin (Restasis)ophthalmic solution; 1 drop both eyes twice daily plus placebo solution. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
Period Title: Overall Study
Started 6 [1] 0
Completed 6 [2] 0
Not Completed 0 0
[1]
Study started in December 2007 (recruited 6 patients total of 20 anticipated)
[2]
Study completed in September 2008(recruited 6 patients total of 20 anticipated)
Arm/Group Title 2 Arm Study - Description Below
Hide Arm/Group Description Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  50.0%
>=65 years
3
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
67  (6.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Change in Ocular Surface Disease Index (OSDI)
Hide Description Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.
Time Frame Start of treatment, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
cyclosporin ophthalmic solution plus placebo solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Tear Film Breakup Time
Hide Description Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Fluorescein Staining Scale
Hide Description Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Schirmer Tear Test With Anesthesia Result
Hide Description Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Change in Severity of Ocular Discomfort
Hide Description This will be calculated using a composite score of the primary and secondary outcome measures.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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

Euphrasia-based homeopathic therapy: ophthalmic solution; 1 drop both eyes twice daily

Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily

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

Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2 Arm Study - Description Below
Hide Arm/Group Description Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
All-Cause Mortality
2 Arm Study - Description Below
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
2 Arm Study - Description Below
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2 Arm Study - Description Below
Affected / at Risk (%)
Total   0/6 (0.00%) 
Early termination leading to small numbers of subjects analyzed
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lenworth Johnson, MD
Organization: University of Missouri
Phone: 573-882-8473
EMail: JohnsonLN@health.missouri.edu
Layout table for additonal information
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01072526     History of Changes
Other Study ID Numbers: LNJ-1
IRB 1095817 ( Other Identifier: University of Missouri )
First Submitted: December 31, 2007
First Posted: February 22, 2010
Results First Submitted: September 4, 2014
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017