Evaluation of Investigational (Frequent Replacement) FRP Lens for Daily Wear

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02362724
• Collaborator: (none)
• Enrollment: 89
• Locations: 6
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 14.8
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the investigational contact lens to a marketed contact lens.

The study results were not used for design validation of investigational contact lens,

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: Sapphire; Device: Pearl	N/A

Detailed Description

The objective of this evaluation is to provide evidence supporting the claim that the performance of the Test Lens is substantially equivalent to that of the Control Lens when used in a one month (up to 30 days) recommended replacement, daily wear modality.

The study results were not used for design validation of investigational contact lens,

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of the CooperVision, Inc. Sapphire and Pearl Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear.
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sapphire Subjects randomized to the experimental contact lens over the study duration	Device: Sapphire; silicone hydrogel contact lens
Active Comparator: Pearl Subjects randomized to the active comparator contact lens over the study duration	Device: Pearl; silicone hydrogel contact lens

Outcome Measures

Primary Outcome Measures

1. Slit Lamp Findings for Epithelial Edema [Baseline (After lens dispensing)]

   Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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. Slit Lamp Findings for Epithelial Edema [1 Month]

   Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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. Slit Lamp Findings for Stromal Edema [Baseline (After lens dispensing)]

   Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae)

4. Slit Lamp Findings for Stromal Edema [1 month]

   Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae)

5. Slit Lamp Findings for Corneal Infiltrates [Baseline (After lens dispensing)]

   Slit Lamp Findings for Corneal Infiltrates - Present, Absent

6. Slit Lamp Findings for Corneal Infiltrates [1 Month]

   Slit Lamp Findings for Corneal Infiltrates - Present, Absent

7. Slit Lamp Findings for Corneal Vascularization [Baseline (After lens dispensing)]

   Slit Lamp Findings for Corneal Vascularization on a grade 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)

8. Slit Lamp Findings for Corneal Vascularization [1 month]

   Slit Lamp Findings for Corneal Vascularization on a grade 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)

9. Slit Lamp Findings for Limbal Hyperemia [Baseline (After lens dispensing)]

   Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)

10. Slit Lamp Findings for Limbal Hyperemia [1 month]

    Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)

11. Slit Lamp Findings for Bulbar Hyperemia [Baseline (After lens dispensing)]

    Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)

12. Slit Lamp Findings for Bulbar Hyperemia [1 month]

    Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)

13. Slit Lamp Findings for Palpebral Conjunctiva [Baseline (After lens dispensing)]

    Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent

14. Slit Lamp Findings for Palpebral Conjunctiva [1 month]

    Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent

15. Slit Lamp Findings for Other Findings [Baseline (After lens dispensing)]

    Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)

16. Slit Lamp Findings for Other Findings [1 month]

    Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Prior to being considered eligible to participate in this study, each subject MUST:

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

2. Have:

3. Read the Informed Consent

4. been given an explanation of the Informed Consent

5. indicated understanding of the Informed Consent

6. signed the Informed Consent document.

7. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.

8. Be an adapted, 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.

11. Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.

12. Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.

13. To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal.

Exclusion Criteria:

• Subjects may not be enrolled in this study if any of the following apply: The subject is currently or has:

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 or of the investigational office staff.

6. Has a known sensitivity to the ingredients used in the MPS approved for use in the study and is unable or unwilling to use the alternate care system.

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

8. Is aphakic or psuedophakic.

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. The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures.

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

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

14. Slit lamp findings that would contraindicate contact lens wear, including but not limited to:

• Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2

• Pterygium

• Corneal scars within the visual axis

• Neovascularization or ghost vessels > 1.0 mm in from the limbus

• Giant papillary conjunctivitis (GPC) of > Grade 2

• Anterior uveitis or iritis

• Seborrheic eczema, seborrheic conjunctivitis or blepharitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eric M White OD, Inc.	San Diego	California	United States	92123
2	Office of Mark E Nakano, O.D.	Torrance	California	United States	90503
3	Advanced Family Eye Care	Denver	North Carolina	United States	28037
4	Quinn Foster & Associates	Athens	Ohio	United States	45701
5	Primary Eyecare Group, P.C.	Brentwood	Tennessee	United States	37027
6	Premier Vision Services, LLC	Amarillo	Texas	United States	79119

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Study Chair: Steven L Saltzman, MD, FACOG, Sterling IRB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02362724
• Other Study ID Numbers: FC131202
• First Posted: Feb 13, 2015
• Last Update Posted: Oct 14, 2020
• Last Verified: Dec 1, 2015

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Period Title: Overall Study
STARTED	59	30
COMPLETED	53	29
NOT COMPLETED	6	1

Baseline Characteristics

Arm/Group Title	Sapphire	Pearl	Total
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens	Total of all reporting groups
Overall Participants	59	30	89
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	59 100%	30 100%	89 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.8 (8.820)	33.3 (8.890)	32.9 (8.800)
Sex: Female, Male (Count of Participants)
Female	40 67.8%	18 60%	58 65.2%
Male	19 32.2%	12 40%	31 34.8%
Race/Ethnicity, Customized (participants) [Number]
Asian	1 1.7%	0 0%	1 1.1%
White	47 79.7%	23 76.7%	70 78.7%
Japanese	9 15.3%	5 16.7%	14 15.7%
Black	1 1.7%	1 3.3%	2 2.2%
Hispanic	1 1.7%	1 3.3%	2 2.2%
Other	1 1.7%	0 0%	1 1.1%
Region of Enrollment (participants) [Number]
United States	59 100%	30 100%	89 100%

Outcome Measures

1. Primary Outcome

Title	Slit Lamp Findings for Epithelial Edema
Description	Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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 (After lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	53	29
Measure Eyes	106	58
Grade 0	106	58
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

2. Primary Outcome

Title	Slit Lamp Findings for Epithelial Edema
Description	Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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	1 Month

Outcome Measure Data

Analysis Population Description

Data for two test eyes and two control eyes were not collected.

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	52	28
Measure Eyes	104	56
Grade 0	104	56
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

3. Primary Outcome

Title	Slit Lamp Findings for Stromal Edema
Description	Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae)
Time Frame	Baseline (After lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	53	29
Measure Eyes	106	58
Grade 0	106	58
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

4. Primary Outcome

Title	Slit Lamp Findings for Stromal Edema
Description	Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Data for two test eyes and two control eyes were not collected

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	52	28
Measure Eyes	104	56
Grade 0	104	56
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

5. Primary Outcome

Title	Slit Lamp Findings for Corneal Infiltrates
Description	Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Time Frame	Baseline (After lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	53	29
Measure Eyes	106	58
Present	0	0
Absent	106	58

6. Primary Outcome

Title	Slit Lamp Findings for Corneal Infiltrates
Description	Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

Data for two test lens and two control lens were not collected

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	52	28
Measure Eyes	104	56
Present	0	0
Absent	104	56

7. Primary Outcome

Title	Slit Lamp Findings for Corneal Vascularization
Description	Slit Lamp Findings for Corneal Vascularization on a grade 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)
Time Frame	Baseline (After lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	53	29
Measure Eyes	106	58
Grade 0	103	52
Grade 1	3	6
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

8. Primary Outcome

Title	Slit Lamp Findings for Corneal Vascularization
Description	Slit Lamp Findings for Corneal Vascularization on a grade 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)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Data for two test eyes and two control eyes were not collected

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	52	28
Measure Eyes	104	56
Grade 0	101	52
Grade 1	3	4
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

9. Primary Outcome

Title	Slit Lamp Findings for Limbal Hyperemia
Description	Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 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 (After lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	53	29
Measure Eyes	106	58
Grade 0	77	48
Grade 1	29	10
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

10. Primary Outcome

Title	Slit Lamp Findings for Limbal Hyperemia
Description	Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 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	1 month

Outcome Measure Data

Analysis Population Description

Data for two test eyes and two control eyes were not collected.

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	52	28
Measure Eyes	104	56
Grade 0	76	44
Grade 1	28	12
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

11. Primary Outcome

Title	Slit Lamp Findings for Bulbar Hyperemia
Description	Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 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 (After lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	53	29
Measure Eyes	106	56
Grade 0	64	41
Grade 1	42	17
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

12. Primary Outcome

Title	Slit Lamp Findings for Bulbar Hyperemia
Description	Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 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	1 month

Outcome Measure Data

Analysis Population Description

Data for two test eyes and two control eyes were not collected.

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	52	28
Measure Eyes	104	56
Grade 0	70	42
Grade 1	33	14
Grade 2	1	0
Grade 3	0	0
Grade 4	0	0

13. Primary Outcome

Title	Slit Lamp Findings for Palpebral Conjunctiva
Description	Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Time Frame	Baseline (After lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	53	29
Measure Eyes	106	58
Present	34	19
Absent	72	39

14. Primary Outcome

Title	Slit Lamp Findings for Palpebral Conjunctiva
Description	Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Data for two test eyes and two control eyes were not collected

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	52	28
Measure Eyes	104	56
Present	47	20
Absent	57	36

15. Primary Outcome

Title	Slit Lamp Findings for Other Findings
Description	Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)
Time Frame	Baseline (After lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	53	29
Measure Eyes	106	56
Grade 0	104	54
Grade 1	2	4
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

16. Primary Outcome

Title	Slit Lamp Findings for Other Findings
Description	Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Data for two test eyes and two control eyes were not collected

Arm/Group Title	Sapphire	Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens	Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
Measure Participants	52	28
Measure Eyes	104	56
Grade 0	101	54
Grade 1	3	2
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

Adverse Events

Time Frame	From Dispense up to one month on study lenses
Arm/Group Title	Sapphire		Pearl
Arm/Group Description	Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens		Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens
All Cause Mortality
	Sapphire		Pearl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/30 (0%)
Serious Adverse Events
	Sapphire		Pearl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Sapphire		Pearl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/59 (11.9%)		2/30 (6.7%)
Eye disorders
Pappilary Conjuctivitis	6/59 (10.2%)	6	1/30 (3.3%)	1
Corneal Infiltrate	0/59 (0%)	0	1/30 (3.3%)	1
Foreign body Abrasion	1/59 (1.7%)	1	0/30 (0%)	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.