Acute Comfort of Lubricant Eye Drop FID 111421

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00673959
• Collaborator: (none)
• Enrollment: 20
• Arms: 2

Study Details

Study Description

Brief Summary

To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Other: Lubricant Eye Drop FID 111421; Other: Optive Lubricant Eye Drop	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lubricant Eye Drop FID 111421 Lubricant Eye Drop FID 111421 1 drop each eye one time	Other: Lubricant Eye Drop FID 111421; Lubricant Eye Drop FID 111421 1 drop each eye one time
Active Comparator: Optive Lubricant Eye Drop Optive Lubricant Eye Drop 1 drop each eye one time	Other: Optive Lubricant Eye Drop; Optive Lubricant Eye Drop 1 drop each eye one time

Outcome Measures

Primary Outcome Measures

1. Drop Comfort Upon Instillation [upon instillation]

   Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Documented diagnosis of dry eye

• Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

• Age related

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00673959
• Other Study ID Numbers: C-07-08
• First Posted: May 7, 2008
• Last Update Posted: Feb 2, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Alcon Research: Dry eye; artificial tears
• Additional relevant MeSH terms: Dry Eye Syndromes; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

Participant Flow

Recruitment Details	20 Dry Eye Subjects
Pre-assignment Detail	Randomized, double-masked, crossover

Arm/Group Title	Lubricant Drops, Then Optive Drops	Optive Drops, Then Lubricant Drops
Arm/Group Description	Patients received Lubricant Drops first, then received Optive Drops	Patients received Optive Drops first, then received Lubricant Drops
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 85%
>=65 years	3 15%
Sex: Female, Male (Count of Participants)
Female	16 80%
Male	4 20%

Outcome Measures

1. Primary Outcome

Title	Drop Comfort Upon Instillation
Description	Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Time Frame	upon instillation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lubricant Eye Drop FID 111421	Optive Lubricant Eye Drop
Arm/Group Description
Measure Participants	20	20
Mean (Standard Deviation) [Units on a scale]	1.7 (1.8)	1.3 (1.4)

Adverse Events

Arm/Group Title	Lubricant Eye Drop FID 111421		Optive Lubricant Eye Drop
Arm/Group Description
All Cause Mortality
	Lubricant Eye Drop FID 111421		Optive Lubricant Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lubricant Eye Drop FID 111421		Optive Lubricant Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Lubricant Eye Drop FID 111421		Optive Lubricant Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI should hold confidential, and not disclose directly or indirectly to any third party onther than Contractors, the data arising out of the study.