Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02366910
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 25.5

Study Details

Study Description

Brief Summary

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: omafilcon A; Device: delefilcon A	N/A

Detailed Description

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: omafilcon A Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).	Device: omafilcon A; Each subject randomized to wear either the test or control in either the left of right eye.; Device: delefilcon A; Each subject randomized to wear either the test or control in either the left of right eye.
Active Comparator: delefilcon A Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).	Device: omafilcon A; Each subject randomized to wear either the test or control in either the left of right eye.; Device: delefilcon A; Each subject randomized to wear either the test or control in either the left of right eye.

Outcome Measures

Primary Outcome Measures

1. Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A [12 Hours of Wear]

   Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

2. Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A [12 Hours of Wear]

   Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

3. Moisture Retention (Mean) of Omafilcon A and Delefilcon A [12 Hours]

   Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

4. Moisture Retention (Median) of Omafilcon A and Delefilcon A [12 Hours]

   Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.

5. Is able to wear lenses for at least 12 hours a day.

Exclusion Criteria:

1. Is participating in any concurrent clinical study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Has undergone refractive error surgery;

• *For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo School of Optometry	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lydon Jones, PhD FC, Director, Centre for Contact Lens Research
• Principal Investigator: Farah Panjwani, BSc RAQ, Univerisy of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02366910
• Other Study ID Numbers: EX-MKTG-45
• First Posted: Feb 19, 2015
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Dehydration

Study Results

Participant Flow

Arm/Group Title	Overall Participants
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye. delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
Period Title: Overall Study
STARTED	26
COMPLETED	21
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye. delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
Overall Participants	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.9 (10.1)
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	24
Sex: Female, Male (Count of Participants)
Female	16 76.2%
Male	5 23.8%

Outcome Measures

1. Primary Outcome

Title	Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A
Description	Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Time Frame	12 Hours of Wear

Outcome Measure Data

Analysis Population Description

Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.

Arm/Group Title	Omafilcon A	Delefilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
Measure Participants	18	18
Mean (Standard Deviation) [absolute WC change]	1.59 (0.85)	3.82 (1.75)

2. Primary Outcome

Title	Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A
Description	Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Time Frame	12 Hours of Wear

Outcome Measure Data

Analysis Population Description

Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.

Arm/Group Title	Omafilcon A	Delefilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
Measure Participants	18	18
Median (Full Range) [absolute WC change]	1.20	3.38

3. Primary Outcome

Title	Moisture Retention (Mean) of Omafilcon A and Delefilcon A
Description	Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Time Frame	12 Hours

Outcome Measure Data

Analysis Population Description

Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.

Arm/Group Title	Omafilcon A	Delefilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
Measure Participants	18	18
Mean (Standard Deviation) [percentage of dehyrdation]	2.58 (1.38)	11.5 (5.2)

4. Primary Outcome

Title	Moisture Retention (Median) of Omafilcon A and Delefilcon A
Description	Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Time Frame	12 Hours

Outcome Measure Data

Analysis Population Description

Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.

Arm/Group Title	Omafilcon A	Delefilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
Measure Participants	18	18
Median (Full Range) [percentage of dehyrdation]	1.98	9.89

Adverse Events

Time Frame	From dispense up to 12 hour for each study lenses
Arm/Group Title	Omafilcon A		Delefilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.		Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
All Cause Mortality
	Omafilcon A		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omafilcon A		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Omafilcon A		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.