IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00768898
First received: October 6, 2008
Last updated: March 19, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the correct volume of lissamine green to use when assessing conjunctival staining, and to determine the time course needed to evaluate conjunctival staining after lissamine green has been instilled in the eye.
| Condition | Intervention |
|---|---|
| Conjunctival Staining | Other: 2.5/5.0/10.0 µL lissamine green |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Conjunctival Staining at 1 Minute [ Time Frame: 1 minute after instillation ]Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit.
- Conjunctival Staining at 2 Minutes [ Time Frame: 2 minutes after instillation ]Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit.
- Conjunctival Staining at 3 Minutes [ Time Frame: 3 minutes after instillation ]Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit.
- Conjunctival Staining at 4 Minutes [ Time Frame: 4 minutes after instillation ]Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit.
- Conjunctival Staining at 5 Minutes [ Time Frame: 5 minutes after instillation ]Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit.
| Enrollment: | 30 |
| Study Start Date: | August 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 2.5 microliters lissamine green |
Other: 2.5/5.0/10.0 µL lissamine green
vital stain solution
|
| 5.0 microliters lissamine green |
Other: 2.5/5.0/10.0 µL lissamine green
vital stain solution
|
| 10.0 microliters lissamine green |
Other: 2.5/5.0/10.0 µL lissamine green
vital stain solution
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
community sample
Criteria
Inclusion Criteria:
- conjunctival staining
Exclusion Criteria:
- ocular pathology
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768898
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768898
Locations
| United States, Texas | |
| Alcon Call Center for Trial Locations | |
| Fort Worth, Texas, United States, 76134 | |
Sponsors and Collaborators
Alcon Research
More Information
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00768898 History of Changes |
| Other Study ID Numbers: |
M-08-01 |
| Study First Received: | October 6, 2008 |
| Results First Received: | September 21, 2009 |
| Last Updated: | March 19, 2012 |
Keywords provided by Alcon Research:
|
conjunctival staining |
ClinicalTrials.gov processed this record on August 16, 2017