Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green - Full Text View

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 ÂµL 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ÂµL lissamine green vital stain solution
5.0 microliters lissamine green	Other: 2.5/5.0/10.0 ÂµL lissamine green vital stain solution
10.0 microliters lissamine green	Other: 2.5/5.0/10.0 ÂµL lissamine green vital stain solution

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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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

No publications provided


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
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:


conjunctival staining

ClinicalTrials.gov processed this record on February 27, 2015