Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01423773
• Collaborator: Bascom Palmer Eye Institute (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

The purpose of this study was to compare the fit and comfort of two types of contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Ocular Comfort	Device: Lotrafilcon A test contact lens; Device: Lotrafilcon A control contact lens; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)	N/A

Detailed Description

The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Official Title: Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Lotrafilcon A test/lotrafilcon A control Lotrafilcon A test contact lens worn first, with lotrafilcon A control contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2.	Device: Lotrafilcon A test contact lens; Silicone hydrogel single vision, soft contact lens with alternate parameters; Device: Lotrafilcon A control contact lens; Silicone hydrogel single vision, soft contact lens; Other Names: Night&Day ; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT); Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear
Other: Lotrafilcon A control/lotrafilcon A test Lotrafilcon A control contact lens worn first, with lotrafilcon A test contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2.	Device: Lotrafilcon A test contact lens; Silicone hydrogel single vision, soft contact lens with alternate parameters; Device: Lotrafilcon A control contact lens; Silicone hydrogel single vision, soft contact lens; Other Names: Night&Day ; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT); Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear

Outcome Measures

Primary Outcome Measures

1. Final Comfort [Day 2, Hour 10]

   Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Be of legal age of consent and sign Informed Consent document.

• Normal binocularity.

• Be able to wear soft contact lenses.

• Willing to comply with the wear and study visit schedule.

• Spherical contact lens prescription within 0.50 diopter of the available lens powers.

• Spectacle cylinder less than or equal to 1.50 diopter.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks of enrollment.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Currently enrolled in any clinical trial.

• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McKnight Building, Bascom Palmer Eye Institute	Miami	Florida	United States	33136

Sponsors and Collaborators

• CIBA VISION
• Bascom Palmer Eye Institute

Investigators

• Principal Investigator: Jianhua Wang, MD, PhD, Bascom Palmer Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01423773
• Other Study ID Numbers: P-367-C-800
• First Posted: Aug 26, 2011
• Last Update Posted: Jun 28, 2013
• Last Verified: Nov 1, 2012

Study Results

Participant Flow

Recruitment Details	Partipants were recruited from one US study center.
Pre-assignment Detail	This reporting group includes all enrolled participants.

Arm/Group Title	Lotrafilcon A Test, Then Lotrafilcon A Control	Lotrafilcon A Control, Then Lotrafilcon A Test
Arm/Group Description	Lotrafilcon A test contact lenses worn in Period One, with lotrafilcon A control contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.	Lotrafilcon A control contact lenses worn in Period One, with lotrafilcon A test contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
Period Title: Period One, 2 Days
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: Period One, 2 Days
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.0 (10.0)
Sex: Female, Male (Count of Participants)
Female	14 70%
Male	6 30%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Final Comfort
Description	Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").
Time Frame	Day 2, Hour 10

Outcome Measure Data

Analysis Population Description

All enrolled participants

Arm/Group Title	Lotrafilcon A Test	Lotrafilcon A Control
Arm/Group Description	Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.	Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
Measure Participants	20	20
Mean (Standard Deviation) [Units on a scale]	87.6 (10.5)	87.9 (11.1)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study.
Adverse Event Reporting Description	This reporting group includes all enrolled participants.
Arm/Group Title	Lotrafilcon A Test		Lotrafilcon A Control
Arm/Group Description	Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.		Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
All Cause Mortality
	Lotrafilcon A Test		Lotrafilcon A Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon A Test		Lotrafilcon A Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon A Test		Lotrafilcon A Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

The sample size may be small for establishing relationship between ocular comfort and other measurable variables.

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.