A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01965262
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Hema-copolymer Lens; Device: etafilcon A Lens	N/A

Detailed Description

This is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. Limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in East Asian countries.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hema-copolymer Lens Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.	Device: Hema-copolymer Lens; contact lens; Device: etafilcon A Lens; contact lens
Active Comparator: etafilcon A Lens Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.	Device: Hema-copolymer Lens; contact lens; Device: etafilcon A Lens; contact lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity - Hema-copolymer and Etafilcon A [Baseline]

   Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.

2. Visual Acuity - Hema-copolymer and Etafilcon A [1 week]

   Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.

3. Biomicroscopy - Hema-copolymer and Etafilcon A [1 week]

   Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).

4. Lens Surface - Deposition - Hema-copolymer and Etafilcon A [Baseline]

   Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.

5. Lens Surface - Deposition - Hema-copolymer and Etafilcon A [1 week]

   Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.

6. Lens Surface - Debris - Hema-copolymer and Etafilcon A [Baseline]

   Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.

7. Lens Surface - Debris - Hema-copolymer and Etafilcon A [1 week]

   Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.

8. Lens Surface - Wettability - Hema-copolymer and Etafilcon A [Baseline]

   Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.

9. Lens Surface - Wettability - Hema-copolymer and Etafilcon A [1 week]

   Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.

10. Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A [Baseline]

    Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal

11. Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A [1 week]

    Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal

12. Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A [Baseline]

    Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior

13. Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A [1 week]

    Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior

14. Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A [Baseline]

    Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

15. Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A [1 week]

    Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

16. Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A [Baseline]

    Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

17. Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A [1 week]

    Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

18. Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A [Baseline]

    Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.

19. Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A [1 week]

    Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.

20. Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A [Baseline]

    Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.

21. Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A [1 week]

    Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.

22. Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A [Baseline]

    Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.

23. Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A [1 week]

    Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.

24. Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A [1 week]

    Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.

25. Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A [1 week]

    Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.

26. Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A [Baseline]

    Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.

27. Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A [1 week]

    Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.

28. Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A [Baseline]

    Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.

29. Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A [1 week]

    Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Subjects will only be eligible for the study if:

• They are 18 years of age and above.

• They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

• They are willing and able to follow the protocol.

• They agree not to participate in other clinical research for the duration of this study.

• They can attain at least 6/9 in each eye with the study lenses within the available power range.

• They can be fitted with study lenses within the available power range.

• The currently use soft contact lenses, or have done so within the last six months.

Exclusion Criteria:

Subjects will not be able to take part in the study if:

• They have an ocular disorder which would normally contraindicate contact lens wear.

• They have a systemic disorder which would normally contraindicate contact lens wear.

• They are using any topical medication such as eye drops or ointment.

• They have had cataract surgery.

• They have had corneal refractive surgery.

• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

• They are pregnant or lactating.

• They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

• They have any infectious disease which would normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions.

• They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research - The University of Manchester	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Carole Maldonado-Codinal, PhD, Eurolens Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01965262
• Other Study ID Numbers: CV13-545
• First Posted: Oct 18, 2013
• Last Update Posted: Mar 16, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Thirty subjects were dispensed lenses, and nineteen subjects successfully wore both study products.

Arm/Group Title	Hema-copolymer Lens, Then Etafilcon A Lens	Etafilcon A Lens, Then Hema-copoloymer Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair.	Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair.
Period Title: First Intervention (7 Days)
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0
Period Title: First Intervention (7 Days)
STARTED	15	15
COMPLETED	14	5
NOT COMPLETED	1	10

Baseline Characteristics

Arm/Group Title	Overall Baseline Characteristics
Arm/Group Description	Randomized to wear the Hema-copolymer lens pair or the etafilcon A lens pair for one week then cross over to the alternate pair Hema-copolymer Lens: Hema-copolymer lens pair or the Etafilcon A lens pair etafilcon A Lens: Hema-copolymer lens pair or the Etafilcon A lens pair
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.2 (11.2)
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	29.2
Sex: Female, Male (Count of Participants)
Female	22 73.3%
Male	8 26.7%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity - Hema-copolymer and Etafilcon A
Description	Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	30	30
High Contrast	-0.08 (0.09)	-0.04 (0.09)
Low Contrast	0.17 (0.10)	0.20 (0.14)

2. Primary Outcome

Title	Visual Acuity - Hema-copolymer and Etafilcon A
Description	Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	28	20
High Contrast	-0.08 (0.10)	-0.04 (0.10)
Low Contrast	0.18 (0.09)	0.23 (0.10)

3. Primary Outcome

Title	Biomicroscopy - Hema-copolymer and Etafilcon A
Description	Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Conjunctival hyperaemia	0.96 (0.18)	0.96 (0.19)
Limbal hyperameia	0.86 (0.27)	0.79 (0.25)
Corneal vascularisation	0.10 (0.22)	0.11 (0.26)
Microcysts	0.00 (0.00)	0.00 (0.00)
Oedema	0.00 (0.00)	0.00 (0.00)
Corenal Staining	0.26 (0.41)	0.44 (0.55)
Conjunctival Staining	0.37 (0.28)	0.33 (0.34)
Papillary Conjunctivitis	0.87 (0.35)	0.84 (0.37)

4. Primary Outcome

Title	Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Description	Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at baseline.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	30	30
Grade 0	29 96.7%	30 NaN
Grade 1	1 3.3%	0 NaN
Grade 2	0 0%	0 NaN
Grade 3	0 0%	0 NaN
Grade 4	0 0%	0 NaN

5. Primary Outcome

Title	Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Description	Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Grade 0	26 86.7%	14 NaN
Grade 1	3 10%	6 NaN
Grade 2	0 0%	0 NaN
Grade 3	0 0%	0 NaN
Grade 4	0 0%	0 NaN

6. Primary Outcome

Title	Lens Surface - Debris - Hema-copolymer and Etafilcon A
Description	Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All 30 subjects were dispensed lenses, and lens surface of debris measurements were obtained at baseline.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	30	30
Grade 0	28 93.3%	27 NaN
Grade 1	1 3.3%	3 NaN
Grade 2	1 3.3%	0 NaN
Grade 3	0 0%	0 NaN
Grade 4	0 0%	0 NaN

7. Primary Outcome

Title	Lens Surface - Debris - Hema-copolymer and Etafilcon A
Description	Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Grade 0	29 96.7%	18 NaN
Grade 1	0 0%	2 NaN
Grade 2	0 0%	0 NaN
Grade 3	0 0%	0 NaN
Grade 4	0 0%	0 NaN

8. Primary Outcome

Title	Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Description	Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All 30 subjects were dispensed lenses, and lens surface of wettability measurements were obtained at baseline.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	30	30
Grade 0	27 90%	25 NaN
Grade 1	2 6.7%	4 NaN
Grade 2	1 3.3%	1 NaN
Grade 3	0 0%	0 NaN
Grade 4	0 0%	0 NaN

9. Primary Outcome

Title	Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Description	Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Grade 0	19 63.3%	13 NaN
Grade 1	6 20%	6 NaN
Grade 2	4 13.3%	1 NaN
Grade 3	0 0%	0 NaN
Grade 4	0 0%	0 NaN

10. Primary Outcome

Title	Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Description	Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All 30 subjects were dispensed lenses, and lens fit of horizontal centration measurements were obtained at baseline.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	30	30
Measure Eyes	60	60
Extremely Nasal	0	0
Slightly Nasal	1	1
Optimum	21	19
Slightly Temporal	38	40
Extremely Temporal	0	0

11. Primary Outcome

Title	Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Description	Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Measure Eyes	58	40
Extremely Nasal	0	0
Slightly Nasal	2	0
Optimum	11	13
Slightly Temporal	45	27
Extremely Temporal	0	0

12. Primary Outcome

Title	Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Description	Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All 30 subjects were dispensed lenses, and lens fit of vertical centration measurements were obtained at baseline.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	30	30
Measure Eyes	60	60
Extremely Inferior	0	2
Slightly Inferior	22	24
Optimum	28	19
Slightly Superior	10	15
Extremely Superior	0	0

13. Primary Outcome

Title	Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Description	Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Measure Eyes	58	40
Extremely Inferior	0	0
Slightly Inferior	35	11
Optimum	16	17
Slightly Superior	7	12
Extremely Superior	0	0

14. Primary Outcome

Title	Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Description	Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All 30 subjects were dispensed lenses, and lens fit of corneal centration measurements were obtained at baseline.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	30	30
Measure Eyes	60	60
Extremely Inadequate	0	6
Slightly Inadequate	1	8
Optimum	57	46
Slightly Excessive	2	0
Extremely Excessive	0	0

15. Primary Outcome

Title	Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Description	Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Measure Eyes	58	40
Extremely Inadequate	0	0
Slightly Inadequate	3	0
Optimum	53	40
Slightly Excessive	2	0
Extremely Excessive	0	0

16. Primary Outcome

Title	Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Description	Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All 30 subjects were dispensed lenses, and lens movement measurements were obtained at baseline.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	30	30
Measure Eyes	60	60
Extremely Inadequate	0	0
Slightly Inadequate	7	0
Optimum	41	35
Slightly Excessive	12	16
Extremely Excessive	0	9

17. Primary Outcome

Title	Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Description	Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Measure Eyes	58	40
Extremely Inadequate	0	0
Slightly Inadequate	5	2
Optimum	33	28
Slightly Excessive	20	8
Extremely Excessive	0	2

18. Primary Outcome

Title	Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

7 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	24
Mean (Standard Deviation) [units on a scale]	82.2 (13.6)	84.5 (15.3)

19. Primary Outcome

Title	Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Comfort after insertion	80.8 (17.0)	76.0 (16.1)
Comfort before removal	69.1 (19.2)	66.6 (19.5)
Overall comfort	75.8 (16.5)	69.5 (20.8)

20. Primary Outcome

Title	Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

8 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	23
Mean (Standard Deviation) [units on a scale]	87.6 (11.5)	84.4 (12.3)

21. Primary Outcome

Title	Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Distance vision	85.6 (11.3)	71.6 (22.7)
Vision at night	83.3 (14.0)	65.0 (21.3)
Variable vision	83.1 (17.4)	67.4 (22.7)

22. Primary Outcome

Title	Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

8 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	23
Mean (Standard Deviation) [units on a scale]	85.1 (14.7)	87.6 (14.9)

23. Primary Outcome

Title	Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Mean (Standard Deviation) [units on a scale]	80.2 (16.4)	76.4 (17.3)

24. Primary Outcome

Title	Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Mean (Standard Deviation) [units on a scale]	87.2 (15.7)	89.0 (9.0)

25. Primary Outcome

Title	Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Ease of insertion	92.0 (10.3)	77.5 (18.2)
Ease of removal	95.2 (8.1)	90.5 (18.3)

26. Primary Outcome

Title	Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

8 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	23
Mean (Standard Deviation) [units on a scale]	66.9 (16.5)	67.4 (16.7)

27. Primary Outcome

Title	Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	20
Mean (Standard Deviation) [units on a scale]	66.7 (20.0)	68.0 (20.2)

28. Primary Outcome

Title	Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

8 subjects discontinued the study.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	29	23
Mean (Standard Deviation) [units on a scale]	81.3 (14.6)	78.9 (14.5)

29. Primary Outcome

Title	Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description	Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.

Arm/Group Title	Hema-copolymer Lens	Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
Measure Participants	28	20
Mean (Standard Deviation) [units on a scale]	75.0 (15.2)	63.9 (21.5)

Adverse Events

Arm/Group Title	Hema-copolymer Lens		Etafilcon A Lens
Arm/Group Description	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens		Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens
All Cause Mortality
	Hema-copolymer Lens		Etafilcon A Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Hema-copolymer Lens		Etafilcon A Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Hema-copolymer Lens		Etafilcon A Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/19 (5.3%)		0/19 (0%)
Eye disorders
Unilateral red eye	1/19 (5.3%)	1	0/19 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between the Principal Investigator and the Sponsor that restricts the PI's right to discuss or publish trial results after the trial is completed without prior approval of Sponsor. The investigator will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.