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

Conditions

Conjunctival Staining

Keywords

conjunctival, staining

Brief summary

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.

Related papers

No related papers found yet.

Interventions

OTHER2.5/5.0/10.0 ÂµL lissamine green

vital stain solution

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* conjunctival staining

Exclusion criteria

* ocular pathology

Design outcomes

Primary

Measure	Time frame	Description
Conjunctival Staining at 1 Minute	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	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	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	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	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.

Countries

United States

Participant flow

Recruitment details

30 subjects with conjunctival staining and no other ocular pathology were recruited and enrolled.

Pre-assignment details

This reporting group includes all enrolled participants.

Participants by arm

Arm	Count
Overall All enrolled participants	30
Total	30

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Headache	1
Overall Study	Unrelated injury	1

Baseline characteristics

Characteristic	Overall
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	30 Participants
Sex: Female, Male Female	18 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 30	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30	0 / 30

Outcome results

Primary

Conjunctival Staining at 1 Minute

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.

Time frame: 1 minute after instillation