Trial Outcomes & Findings for Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease (NCT NCT01072526)
NCT ID: NCT01072526
Last Updated: 2017-01-12
Results Overview
Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.
TERMINATED
PHASE2
7 participants
Start of treatment, 6 weeks
2017-01-12
Participant Flow
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.
Participants will stop all common artificial tear use for 2 weeks prior to baseline examination and randomization.
Participant milestones
| Measure |
Intervention
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).
|
Control
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).
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
|
Overall Study
COMPLETED
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
Baseline characteristics by cohort
| Measure |
2 Arm Study - Description Below
n=6 Participants
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).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of treatment, 6 weeksPopulation: 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.
Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: 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.
Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeksPopulation: 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.
This will be calculated using a composite score of the primary and secondary outcome measures.
Outcome measures
Outcome data not reported
Adverse Events
2 Arm Study - Description Below
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This study had no external sponsors. It was supported by the University of Missouri, my employer. The University of Missouri can review the data at anytime.
- Publication restrictions are in place
Restriction type: OTHER