Trial Outcomes & Findings for Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green (NCT NCT00768898)

NCT ID: NCT00768898

Last Updated: 2012-04-13

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: 1 minute after instillation
• Results posted on: 2012-04-13

Participant Flow

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

This reporting group includes all enrolled participants.

Participant milestones

Measure	Overall All enrolled participants
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Overall All enrolled participants
Overall Study Unrelated injury	1
Overall Study Headache	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Overall n=30 Participants All enrolled participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 minute after instillation

Population: Analysis conducted per protocol. All subjects participated in each arm/group.

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.

Outcome measures

Measure	2.5 Microliters Lissamine Green n=21 Participants 2.5 microliters lissamine green were instilled in each eye.	5.0 Microliters Lissamine Green n=21 Participants 5.0 microliters lissamine green instilled in each eye	10.0 Microliters Lissamine Green n=21 Participants 10.0 microliters lissamine green instilled in each eye
Conjunctival Staining at 1 Minute	3.29 Units on a scale Standard Deviation 1.58	3.67 Units on a scale Standard Deviation 1.72	3.98 Units on a scale Standard Deviation 1.75

PRIMARY outcome

Timeframe: 2 minutes after instillation

Population: Analysis conducted per protocol. All subjects participated in each arm/group.

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.

Outcome measures

Measure	2.5 Microliters Lissamine Green n=21 Participants 2.5 microliters lissamine green were instilled in each eye.	5.0 Microliters Lissamine Green n=21 Participants 5.0 microliters lissamine green instilled in each eye	10.0 Microliters Lissamine Green n=21 Participants 10.0 microliters lissamine green instilled in each eye
Conjunctival Staining at 2 Minutes	3.67 Units on a scale Standard Deviation 1.75	4.29 Units on a scale Standard Deviation 1.76	4.64 Units on a scale Standard Deviation 1.75

PRIMARY outcome

Timeframe: 3 minutes after instillation

Population: Analysis conducted per protocol. All subjects participated in each arm/group.

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.

Outcome measures

Measure	2.5 Microliters Lissamine Green n=21 Participants 2.5 microliters lissamine green were instilled in each eye.	5.0 Microliters Lissamine Green n=21 Participants 5.0 microliters lissamine green instilled in each eye	10.0 Microliters Lissamine Green n=21 Participants 10.0 microliters lissamine green instilled in each eye
Conjunctival Staining at 3 Minutes	3.02 Units on a scale Standard Deviation 1.60	3.88 Units on a scale Standard Deviation 1.85	4.12 Units on a scale Standard Deviation 1.92

PRIMARY outcome

Timeframe: 4 minutes after instillation

Population: Analysis conducted per protocol. All subjects participated in each arm/group.

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.

Outcome measures

Measure	2.5 Microliters Lissamine Green n=21 Participants 2.5 microliters lissamine green were instilled in each eye.	5.0 Microliters Lissamine Green n=21 Participants 5.0 microliters lissamine green instilled in each eye	10.0 Microliters Lissamine Green n=21 Participants 10.0 microliters lissamine green instilled in each eye
Conjunctival Staining at 4 Minutes	2.48 Units on a scale Standard Deviation 1.63	3.14 Units on a scale Standard Deviation 1.75	3.69 Units on a scale Standard Deviation 1.81

PRIMARY outcome

Timeframe: 5 minutes after instillation

Population: Analysis conducted per protocol. All subjects participated in each arm/group.

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.

Outcome measures

Measure	2.5 Microliters Lissamine Green n=21 Participants 2.5 microliters lissamine green were instilled in each eye.	5.0 Microliters Lissamine Green n=21 Participants 5.0 microliters lissamine green instilled in each eye	10.0 Microliters Lissamine Green n=21 Participants 10.0 microliters lissamine green instilled in each eye
Conjunctival Staining at 5 Minutes	2.12 Units on a scale Standard Deviation 1.48	2.67 Units on a scale Standard Deviation 1.78	3.10 Units on a scale Standard Deviation 1.64

Adverse Events

2.5 Microliters Lissamine Green

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

5.0 Microliters Lissamine Green

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

10.0 Microliters Lissamine Green

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alison Ramsey, O.D., Manager

Alcon Research, Ltd.

Phone: 817-551-6986

Email: Alison.ramsey@alconlabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place