On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03881670
• Collaborator: Alcon Research (Industry)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief Summary

The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.

Condition or Disease	Intervention/Treatment	Phase
Hyperopia; Myopia	Device: Lotrafilcon B; Device: lotrafilcon B with Hydraluxe	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
• Actual Study Start Date: Dec 7, 2018
• Actual Primary Completion Date: Feb 8, 2019
• Actual Study Completion Date: Feb 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Lotrafilcon B	Device: Lotrafilcon B; commercially available contact lens; Device: lotrafilcon B with Hydraluxe; commercially available contact lens
Active Comparator: Lotrafilcon B Hydraluxe	Device: Lotrafilcon B; commercially available contact lens; Device: lotrafilcon B with Hydraluxe; commercially available contact lens

Outcome Measures

Primary Outcome Measures

1. Higher Order Aberrations [0-12 hours]

   Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects

Secondary Outcome Measures

1. Subjective Stability of Vision Rating [0-12 hours]

   Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision)

2. Image Quality Metrics [0-12 hours]

   Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Habitual prescription +5.00 D to -6.00 D

• 18-35 years of age

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

• Vertex corrected refractive cylinder must be -0.75 or less.

• Visual acuity best correctable to 20/25 or better for each eye

• The subject must read and sign the Informed Consent form.

• Mesopic pupil size >5.00 mm.

Exclusion Criteria:

• active condition that would prevent contact lens wear

• history of issues of eye alignment or binocularity by self-report

• doctor diagnosed, self-reported accommodative or binocular vision issues

• doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Clinical Optics Research Lab	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Indiana University
• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 5, 2018

More Information

Publications

None provided.

• Responsible Party: Pete Kollbaum, OD, PhD, Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research, Indiana University
• ClinicalTrials.gov Identifier: NCT03881670
• Other Study ID Numbers: Kollbaum002
• First Posted: Mar 19, 2019
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Arm/Group Title	Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe	Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B
Arm/Group Description	First intervention (2+/-1day) Second intervention (2+/-1day)	First intervention (2+/-1day) Second intervention (2+/-1day)
Period Title: Overall Study
STARTED	12	12
Completed First Intervention	12	12
Completed Second Intervetion	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe	Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B	Total
Arm/Group Description	First intervention (2+/-1day) Second intervention (2+/-1day)	First intervention (2+/-1day) Second intervention (2+/-1day)	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	12 100%	24 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.25 (3.57)	24.33 (3.80)	24.29 (3.61)
Sex: Female, Male (Count of Participants)
Female	9 75%	8 66.7%	17 70.8%
Male	3 25%	4 33.3%	7 29.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 16.7%	1 8.3%	3 12.5%
Not Hispanic or Latino	10 83.3%	11 91.7%	21 87.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	3 25%	3 12.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	12 100%	8 66.7%	20 83.3%
More than one race	0 0%	1 8.3%	1 4.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Higher Order Aberrations
Description	Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Time Frame	0-12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotrafilcon B	Lotrafilcon B With Hydraluxe
Arm/Group Description	All subjects (randomized, crossover design)	All subjects (randomized, crossover design)
Measure Participants	24	24
Mean (Standard Deviation) [microns]	0.001646 (0.028867)	0.002629 (0.044299)

2. Secondary Outcome

Title	Subjective Stability of Vision Rating
Description	Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision)
Time Frame	0-12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotrafilcon B	Lotrafilcon B Hydraluxe
Arm/Group Description	Lotrafilcon B: commercially available contact lens lotrafilcon B with Hydraluxe: commercially available contact lens	Lotrafilcon B: commercially available contact lens lotrafilcon B with Hydraluxe: commercially available contact lens
Measure Participants	24	24
Mean (Standard Deviation) [score on a scale]	-5.833 (10.8)	-2.500 (9.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B
	Comments	Change in ratings over time
	Type of Statistical Test	Other
	Comments	Friedman test
Statistical Test of Hypothesis	p-Value	0.0023
	Comments
	Method	Friedman Test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B With Hydraluxe
	Comments	change in ratings over time
	Type of Statistical Test	Other
	Comments	Friedman test
Statistical Test of Hypothesis	p-Value	0.4679
	Comments
	Method	Friedman Test
	Comments

3. Secondary Outcome

Title	Image Quality Metrics
Description	Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Time Frame	0-12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotrafilcon B	Lotrafilcon B With Hydraluxe
Arm/Group Description	All subjects (randomized, crossover design)	All subjects (randomized, crossover design)
Measure Participants	24	24
Mean (Standard Deviation) [microns]	0.015134 (0.051825)	0.013899 (0.036077)

Adverse Events

Time Frame	through study completion, an average of 2 weeks
Arm/Group Title	Lotrafilcon B		Lotrafilcon B With Hydraluxe
Arm/Group Description	During wear of Lotrafilcon B, including all subjects, despite randomization		During wear of Lotrafilcon B With Hydraluxe, including all subjects, despite randomization
All Cause Mortality
	Lotrafilcon B		Lotrafilcon B With Hydraluxe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Lotrafilcon B		Lotrafilcon B With Hydraluxe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B		Lotrafilcon B With Hydraluxe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.