Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03722784
• Collaborator: (none)
• Enrollment: 88
• Locations: 6
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site: 14.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia; Astigmatism	Device: Invigor A (test); Device: Invigor B (control)	N/A

Detailed Description

This study is a multi-centered, daily wear, monthly replacement, bilateral, randomized in a ratio of two to one (2:1) Test to Control, lens blocked (subjects remain in the same lens brand throughout the study), licensed investigator and subject masked, concurrent controlled study with a study duration of approximately three months evaluating performance equivalence of Invigor A (test) over Invigor B (control) contact lenses.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: The subject will know the name of the lens however they will not be aware of which lens is investigational and which lens has been previously cleared. The licensed investigator has not been informed which lens is the investigational lens.
• Primary Purpose: Treatment
• Official Title: Evaluation of the CooperVision, Inc. Invigor A and Invigor B Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear
• Actual Study Start Date: Oct 10, 2018
• Actual Primary Completion Date: Jan 18, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Invigor A (test) Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study.	Device: Invigor A (test); silicone hydrogel lens
Active Comparator: Invigor B (Control) Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study.	Device: Invigor B (control); silicone hydrogel lens

Outcome Measures

Primary Outcome Measures

1. Number of Eyes With Epithelial Edema - Slit Lamp Findings [Baseline]

   Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)

2. Number of Eyes With Epithelial Edema - Slit Lamp Findings [One Month]

   Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)

3. Number of Eyes With Stromal Edema - Slit Lamp Findings [Baseline]

   Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae

4. Number of Eyes With Stromal Edema - Slit Lamp Findings [One Month]

   Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae

5. Number of Eyes With Corneal Vascularization - Slit Lamp Findings [Baseline]

   Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior

6. Number of Eyes With Corneal Vascularization - Slit Lamp Findings [One Month]

   Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior

7. Number of Eyes With Corneal Staining - Slit Lamp Findings [Baseline]

   Corneal Staining with fluorescent on slit lamp findings - Present / Absent

8. Number of Eyes With Corneal Staining - Slit Lamp Findings [One Month]

   Corneal Staining with fluorescent on slit lamp findings - Present / Absent

9. Number of Eyes With Corneal Infiltrates - Slit Lamp Findings [Baseline]

   Corneal Infiltrates on slit lamp findings - Present / Absent

10. Number of Eyes With Corneal Infiltrates - Slit Lamp Findings [One Month]

    Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent

11. Number of Eyes With Limbal Hyperemia - Slit Lamp Findings [Baseline]

    Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).

12. Number of Eyes With Limbal Hyperemia - Slit Lamp Findings [One Month]

    Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).

13. Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings [Baseline]

    Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)

14. Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings [One Month]

    Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)

15. Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings [Baseline]

    Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent

16. Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings [One Month]

    Palpebral Conjunctival Observations on slit lamp findings - Present / Absent

17. Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings [Baseline]

    Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)

18. Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings [One Month]

    Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)

Secondary Outcome Measures

1. Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet [One Month]

   Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• Inclusion Criteria:

1. Be at least 18 years of age as of the date of evaluation for the study

2. Have

3. Read the informed consent document

4. Been given an explanation of the informed consent document

5. indicated understanding of the informed consent document

6. Signed the informed consent document

7. Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments.

8. Be an adapted, frequent replacement, current full - time silicone hydrogel or soft contact lens wearer. An adapted full- time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.

9. Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.

10. Be in good general health, based on his/her knowledge.

• Exclusion Criteria:

1. Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.

2. Poor personal hygiene.

3. Any active participation in another clinical trial during this trial or within 30 days prior to this study.

4. To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.

5. A member, relative or household member of the investigator(s) or of the investigational office staff.

6. A known sensitivity to the ingredients used in the multi-purpose solution approved for use in the study and is unable or unwilling to use the alternate care system.

7. Had previous refractive surgery; or current or previous orthokeratology treatment.

8. Aphakic or pseudophakic.

9. Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.

10. The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.

11. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.

12. A history of papillary conjunctivitis that has interfered with contact lens wear.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mark Nakano. O.D	Torrance	California	United States	90503
2	Vision Care Associates	East Lansing	Michigan	United States	48823
3	The Koetting Associates	Saint Louis	Missouri	United States	63144
4	Quinn, Foster & Associates	Athens	Ohio	United States	45701
5	Primary Eyecare Group, P.C	Brentwood	Tennessee	United States	37027-7552
6	Ziegler Leffingwell Eye Center	West Allis	Wisconsin	United States	53227

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Thomas Quinn, O.D, Quinn, Foster & Associates, OH
• Principal Investigator: Peter Van Hoven, O.D, Primary Eyecare group, P.C, TN
• Principal Investigator: Mark Nakano, O.D, Mark Nakano, O.D, CA
• Principal Investigator: David Ziegler, O.D, Ziegler Leffingwell Eye Center, WI
• Principal Investigator: Cheryl Vincent Riemer, O.D, Vision Care Associates, MI
• Principal Investigator: Carmen Castellano, O.D, The Koetting Associates, MO

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 3, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03722784
• Other Study ID Numbers: FC160322
• First Posted: Oct 29, 2018
• Last Update Posted: Oct 1, 2020
• Last Verified: Aug 1, 2020

• 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.: Yes
• Additional relevant MeSH terms: Astigmatism; Hyperopia

Study Results

Participant Flow

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Period Title: Overall Study
STARTED	58	30
COMPLETED	56	28
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Invigor A (Test)	Invigor B (Control)	Total
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) and Invigor B (control) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) and Invigor B (control) for one month of daily wear during the study. Invigor B (Control): silicone hydrogel lens	Total of all reporting groups
Overall Participants	58	30	88
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	58 100%	30 100%	88 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.19 (8.080)	33.73 (8.497)	33.38 (8.179)
Sex: Female, Male (Count of Participants)
Female	39 67.2%	17 56.7%	56 63.6%
Male	19 32.8%	13 43.3%	32 36.4%
Race/Ethnicity, Customized (participants) [Number]
Black	2 3.4%	2 6.7%	4 4.5%
Chinese	1 1.7%	0 0%	1 1.1%
Hispanic/Latino	4 6.9%	0 0%	4 4.5%
Japanese	5 8.6%	3 10%	8 9.1%
White	43 74.1%	23 76.7%	66 75%
Other	0 0%	2 6.7%	2 2.3%
Chinese/Japanese	1 1.7%	0 0%	1 1.1%
Japanese/Other	2 3.4%	0 0%	2 2.3%
Region of Enrollment (participants) [Number]
United States	58 100%	30 100%	88 100%

Outcome Measures

1. Primary Outcome

Title	Number of Eyes With Epithelial Edema - Slit Lamp Findings
Description	Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Grade 0	112	56
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

2. Primary Outcome

Title	Number of Eyes With Epithelial Edema - Slit Lamp Findings
Description	Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Grade 0	110	54
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

3. Primary Outcome

Title	Number of Eyes With Stromal Edema - Slit Lamp Findings
Description	Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Grade 0	112	56
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

4. Primary Outcome

Title	Number of Eyes With Stromal Edema - Slit Lamp Findings
Description	Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Grade 0	110	54
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

5. Primary Outcome

Title	Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Description	Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Grade 0	98	56
Grade 1	14	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

6. Primary Outcome

Title	Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Description	Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Grade 0	98	54
Grade 1	12	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

7. Primary Outcome

Title	Number of Eyes With Corneal Staining - Slit Lamp Findings
Description	Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Present	10	7
Absent	102	49

8. Primary Outcome

Title	Number of Eyes With Corneal Staining - Slit Lamp Findings
Description	Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Present	20	9
Absent	90	45

9. Primary Outcome

Title	Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Description	Corneal Infiltrates on slit lamp findings - Present / Absent
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Present	0	0
Absent	112	56

10. Primary Outcome

Title	Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Description	Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Present	0	0
Absent	110	54

11. Primary Outcome

Title	Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Description	Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Grade 0	112	54
Grade 1	0	2
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

12. Primary Outcome

Title	Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Description	Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Grade 0	110	52
Grade 1	0	2
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

13. Primary Outcome

Title	Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Description	Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Grade 0	88	50
Grade 1	24	6
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

14. Primary Outcome

Title	Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Description	Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Grade 0	90	46
Grade 1	20	8
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

15. Primary Outcome

Title	Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
Description	Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Present	36	20
Absent	76	36

16. Primary Outcome

Title	Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
Description	Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Present	42	12
Absent	68	42

17. Primary Outcome

Title	Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Description	Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	56	28
Measure Eyes	112	56
Grade 0	112	56
Garde 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

18. Primary Outcome

Title	Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Description	Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
Grade 0	106	52
Garde 1	4	2
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

19. Secondary Outcome

Title	Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
Description	Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Arm/Group Title	Invigor A (Test)	Invigor B (Control)
Arm/Group Description	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens	Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
Measure Participants	55	27
Measure Eyes	110	54
20/20	92	45
20/15	7	4
20/25	11	5

Adverse Events

Time Frame	From dispense up to one month for each study lenses
Arm/Group Title	Invigor A (Test)		Invigor B (Control)
Arm/Group Description	Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens		Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens
All Cause Mortality
	Invigor A (Test)		Invigor B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/28 (0%)
Serious Adverse Events
	Invigor A (Test)		Invigor B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Invigor A (Test)		Invigor B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

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.