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Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia (STAR)

This study has been completed.
Sponsor:
Collaborators:
National Eye Institute (NEI)
Project ORBIS
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00347776
First received: July 3, 2006
Last updated: June 27, 2017
Last verified: June 2017
Results First Received: April 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Trichiasis
Interventions: Drug: azithromycin
Drug: topical tetracycline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were randomly assigned initially to receive single dose of oral azithromycin to subject or single dose of azithromycin to subject & immediate family members or topical tetracycline ointment to subject groups.1 yr data suggested no difference in outcome between 2 azithromycin arms.These 2 groups were combined into 1 group in final analysis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
Intervention 1 Oral azithromycin,single 1g dose to subject only Antibiotic : Oral azithromycin (1 g)
Intervention 2 Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)

Participant Flow for 3 periods

Period 1:   1.5 Month Follow-up
    Control   Intervention 1   Intervention 2
STARTED   484   483   485 
COMPLETED   470   475 [1]   473 [2] 
NOT COMPLETED   14   8   12 
Death                2                0                0 
reached the endpoint                12                8                12 
[1] 473 had no recurrence.2 were lost to follow-up but were still eligible for follow-up at next visits
[2] 472 had no recurrence.1 was lost to follow-up but was still eligible for follow-up at next visits

Period 2:   6 Month Follow-up
    Control   Intervention 1   Intervention 2
STARTED   470   475   473 
COMPLETED   448 [1]   462 [2]   455 [3] 
NOT COMPLETED   22   13   18 
Death                2                1                3 
reached endpont                20                12                15 
[1] 440 had no recurrence.8 were lost to follow-up but were still eligible for follow-up at next visits
[2] 459 had no recurrence.3 were lost to follow-up but were still eligible for follow-up at next visits
[3] 452 had no recurrence.3 were lost to follow-up but were still eligible for follow-up at next visits

Period 3:   12 Month Follow-up
    Control   Intervention 1   Intervention 2
STARTED   448   462   455 
COMPLETED   425   446   436 
NOT COMPLETED   23   16   19 
Lost to Follow-up                7                6                6 
Death                3                4                4 
Reached endpoint                13                6                9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
Intervention1 Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
Intervention2 Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
Total Total of all reporting groups

Baseline Measures
   Control   Intervention1   Intervention2   Total 
Overall Participants Analyzed 
[Units: Participants]
 484   483   485   1452 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.0  (12.8)   48.5  (13.0)   50.0  (12.6)   48.9  (13.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      390  80.6%      366  75.8%      365  75.3%      1121  77.2% 
Male      94  19.4%      117  24.2%      120  24.7%      331  22.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Ethiopia   484   483   485   1452 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recurrent Trichiasis in Tetracycline and Azithromycin Groups   [ Time Frame: Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery ]

2.  Primary:   Recurrent Trichiasis Between Two Azithromycin Arms   [ Time Frame: Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery ]

3.  Secondary:   Surgical Failure   [ Time Frame: 6 weeks ]

4.  Secondary:   Adverse Events   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
1.Azithromycin administered was observed.Compliance was 100%.In tetracycline group,only 1st application of ointment was observed.Data on compliance for next 6 weeks were not collected.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sheila K West
Organization: Johns Hopkins University
phone: 410 955 2606
e-mail: shwest@jhmi.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00347776     History of Changes
Other Study ID Numbers: U01EY013878 ( U.S. NIH Grant/Contract )
Study First Received: July 3, 2006
Results First Received: April 13, 2017
Last Updated: June 27, 2017