Trial Outcomes & Findings for A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens (NCT NCT01965262)
NCT ID: NCT01965262
Last Updated: 2017-03-16
Results Overview
Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
COMPLETED
NA
30 participants
Baseline
2017-03-16
Participant Flow
Thirty subjects were dispensed lenses, and nineteen subjects successfully wore both study products.
Participant milestones
| Measure |
Hema-copolymer Lens, Then Etafilcon A Lens
Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair.
|
Etafilcon A Lens, Then Hema-copoloymer Lens
Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair.
|
|---|---|---|
|
First Intervention (7 Days)
STARTED
|
15
|
15
|
|
First Intervention (7 Days)
COMPLETED
|
15
|
15
|
|
First Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (7 Days)
STARTED
|
15
|
15
|
|
Second Intervention (7 Days)
COMPLETED
|
14
|
5
|
|
Second Intervention (7 Days)
NOT COMPLETED
|
1
|
10
|
Reasons for withdrawal
| Measure |
Hema-copolymer Lens, Then Etafilcon A Lens
Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair.
|
Etafilcon A Lens, Then Hema-copoloymer Lens
Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair.
|
|---|---|---|
|
Second Intervention (7 Days)
Discontinued
|
0
|
1
|
|
Second Intervention (7 Days)
Poor lens fit
|
0
|
9
|
|
Second Intervention (7 Days)
Poor visual acuity
|
1
|
0
|
Baseline Characteristics
A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
Baseline characteristics by cohort
| Measure |
Overall Baseline Characteristics
n=30 Participants
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
|
|---|---|
|
Age, Continuous
|
29.2 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline.
Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
Outcome measures
| Measure |
Etafilcon A Lens
n=30 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=30 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Visual Acuity - Hema-copolymer and Etafilcon A
High Contrast
|
-0.04 logMAR
Standard Deviation 0.09
|
-0.08 logMAR
Standard Deviation 0.09
|
|
Visual Acuity - Hema-copolymer and Etafilcon A
Low Contrast
|
0.20 logMAR
Standard Deviation 0.14
|
0.17 logMAR
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.
Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=28 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Visual Acuity - Hema-copolymer and Etafilcon A
High Contrast
|
-0.04 logMAR
Standard Deviation 0.10
|
-0.08 logMAR
Standard Deviation 0.10
|
|
Visual Acuity - Hema-copolymer and Etafilcon A
Low Contrast
|
0.23 logMAR
Standard Deviation 0.10
|
0.18 logMAR
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Biomicroscopy - Hema-copolymer and Etafilcon A
Conjunctival hyperaemia
|
0.96 units on a scale
Standard Deviation 0.19
|
0.96 units on a scale
Standard Deviation 0.18
|
|
Biomicroscopy - Hema-copolymer and Etafilcon A
Limbal hyperameia
|
0.79 units on a scale
Standard Deviation 0.25
|
0.86 units on a scale
Standard Deviation 0.27
|
|
Biomicroscopy - Hema-copolymer and Etafilcon A
Corneal vascularisation
|
0.11 units on a scale
Standard Deviation 0.26
|
0.10 units on a scale
Standard Deviation 0.22
|
|
Biomicroscopy - Hema-copolymer and Etafilcon A
Microcysts
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Biomicroscopy - Hema-copolymer and Etafilcon A
Oedema
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Biomicroscopy - Hema-copolymer and Etafilcon A
Corenal Staining
|
0.44 units on a scale
Standard Deviation 0.55
|
0.26 units on a scale
Standard Deviation 0.41
|
|
Biomicroscopy - Hema-copolymer and Etafilcon A
Conjunctival Staining
|
0.33 units on a scale
Standard Deviation 0.34
|
0.37 units on a scale
Standard Deviation 0.28
|
|
Biomicroscopy - Hema-copolymer and Etafilcon A
Papillary Conjunctivitis
|
0.84 units on a scale
Standard Deviation 0.37
|
0.87 units on a scale
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: BaselinePopulation: All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at 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.
Outcome measures
| Measure |
Etafilcon A Lens
n=30 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=30 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 0
|
30 participants
|
29 participants
|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 1
|
0 participants
|
1 participants
|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 2
|
0 participants
|
0 participants
|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 3
|
0 participants
|
0 participants
|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 4
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 0
|
14 participants
|
26 participants
|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 1
|
6 participants
|
3 participants
|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 2
|
0 participants
|
0 participants
|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 3
|
0 participants
|
0 participants
|
|
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Grade 4
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All 30 subjects were dispensed lenses, and lens surface of debris measurements were obtained at 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.
Outcome measures
| Measure |
Etafilcon A Lens
n=30 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=30 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 0
|
27 participants
|
28 participants
|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 1
|
3 participants
|
1 participants
|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 2
|
0 participants
|
1 participants
|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 3
|
0 participants
|
0 participants
|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 4
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 1
|
2 participants
|
0 participants
|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 2
|
0 participants
|
0 participants
|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 3
|
0 participants
|
0 participants
|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 4
|
0 participants
|
0 participants
|
|
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Grade 0
|
18 participants
|
29 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All 30 subjects were dispensed lenses, and lens surface of wettability measurements were obtained at 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.
Outcome measures
| Measure |
Etafilcon A Lens
n=30 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=30 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 0
|
25 participants
|
27 participants
|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 1
|
4 participants
|
2 participants
|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 2
|
1 participants
|
1 participants
|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 3
|
0 participants
|
0 participants
|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 4
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 0
|
13 participants
|
19 participants
|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 1
|
6 participants
|
6 participants
|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 2
|
1 participants
|
4 participants
|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 3
|
0 participants
|
0 participants
|
|
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Grade 4
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All 30 subjects were dispensed lenses, and lens fit of horizontal centration measurements were obtained at 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
Outcome measures
| Measure |
Etafilcon A Lens
n=60 Eyes
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=60 Eyes
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Extremely Nasal
|
0 Eyes
|
0 Eyes
|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Slightly Nasal
|
1 Eyes
|
1 Eyes
|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Optimum
|
19 Eyes
|
21 Eyes
|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Slightly Temporal
|
40 Eyes
|
38 Eyes
|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Extremely Temporal
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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
Outcome measures
| Measure |
Etafilcon A Lens
n=40 Eyes
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=58 Eyes
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Extremely Nasal
|
0 Eyes
|
0 Eyes
|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Slightly Nasal
|
0 Eyes
|
2 Eyes
|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Optimum
|
13 Eyes
|
11 Eyes
|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Slightly Temporal
|
27 Eyes
|
45 Eyes
|
|
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Extremely Temporal
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselinePopulation: All 30 subjects were dispensed lenses, and lens fit of vertical centration measurements were obtained at 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
Outcome measures
| Measure |
Etafilcon A Lens
n=60 Eyes
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=60 Eyes
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Extremely Inferior
|
2 Eyes
|
0 Eyes
|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Slightly Inferior
|
24 Eyes
|
22 Eyes
|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Optimum
|
19 Eyes
|
28 Eyes
|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Slightly Superior
|
15 Eyes
|
10 Eyes
|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Extremely Superior
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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
Outcome measures
| Measure |
Etafilcon A Lens
n=40 Eyes
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=58 Eyes
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Optimum
|
17 Eyes
|
16 Eyes
|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Extremely Inferior
|
0 Eyes
|
0 Eyes
|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Slightly Inferior
|
11 Eyes
|
35 Eyes
|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Slightly Superior
|
12 Eyes
|
7 Eyes
|
|
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Extremely Superior
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselinePopulation: All 30 subjects were dispensed lenses, and lens fit of corneal centration measurements were obtained at 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
Outcome measures
| Measure |
Etafilcon A Lens
n=60 Eyes
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=60 Eyes
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Extremely Inadequate
|
6 Eyes
|
0 Eyes
|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Slightly Inadequate
|
8 Eyes
|
1 Eyes
|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Optimum
|
46 Eyes
|
57 Eyes
|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Slightly Excessive
|
0 Eyes
|
2 Eyes
|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Extremely Excessive
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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
Outcome measures
| Measure |
Etafilcon A Lens
n=40 Eyes
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=58 Eyes
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Extremely Inadequate
|
0 Eyes
|
0 Eyes
|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Slightly Inadequate
|
0 Eyes
|
3 Eyes
|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Optimum
|
40 Eyes
|
53 Eyes
|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Slightly Excessive
|
0 Eyes
|
2 Eyes
|
|
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Extremely Excessive
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselinePopulation: All 30 subjects were dispensed lenses, and lens movement measurements were obtained at 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
Outcome measures
| Measure |
Etafilcon A Lens
n=60 Eyes
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=60 Eyes
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Extremely Inadequate
|
0 Eyes
|
0 Eyes
|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Slightly Inadequate
|
0 Eyes
|
7 Eyes
|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Optimum
|
35 Eyes
|
41 Eyes
|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Slightly Excessive
|
16 Eyes
|
12 Eyes
|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Extremely Excessive
|
9 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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
Outcome measures
| Measure |
Etafilcon A Lens
n=40 Eyes
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=58 Eyes
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Extremely Inadequate
|
0 Eyes
|
0 Eyes
|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Slightly Inadequate
|
2 Eyes
|
5 Eyes
|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Optimum
|
28 Eyes
|
33 Eyes
|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Slightly Excessive
|
8 Eyes
|
20 Eyes
|
|
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Extremely Excessive
|
2 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselinePopulation: 7 subjects discontinued the study.
Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.
Outcome measures
| Measure |
Etafilcon A Lens
n=24 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
84.5 units on a scale
Standard Deviation 15.3
|
82.2 units on a scale
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Comfort after insertion
|
76.0 units on a scale
Standard Deviation 16.1
|
80.8 units on a scale
Standard Deviation 17.0
|
|
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Comfort before removal
|
66.6 units on a scale
Standard Deviation 19.5
|
69.1 units on a scale
Standard Deviation 19.2
|
|
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Overall comfort
|
69.5 units on a scale
Standard Deviation 20.8
|
75.8 units on a scale
Standard Deviation 16.5
|
PRIMARY outcome
Timeframe: BaselinePopulation: 8 subjects discontinued the study.
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Outcome measures
| Measure |
Etafilcon A Lens
n=23 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
84.4 units on a scale
Standard Deviation 12.3
|
87.6 units on a scale
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Distance vision
|
71.6 units on a scale
Standard Deviation 22.7
|
85.6 units on a scale
Standard Deviation 11.3
|
|
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Vision at night
|
65.0 units on a scale
Standard Deviation 21.3
|
83.3 units on a scale
Standard Deviation 14.0
|
|
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Variable vision
|
67.4 units on a scale
Standard Deviation 22.7
|
83.1 units on a scale
Standard Deviation 17.4
|
PRIMARY outcome
Timeframe: BaselinePopulation: 8 subjects discontinued the study.
Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Outcome measures
| Measure |
Etafilcon A Lens
n=23 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
87.6 units on a scale
Standard Deviation 14.9
|
85.1 units on a scale
Standard Deviation 14.7
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
76.4 units on a scale
Standard Deviation 17.3
|
80.2 units on a scale
Standard Deviation 16.4
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
89.0 units on a scale
Standard Deviation 9.0
|
87.2 units on a scale
Standard Deviation 15.7
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
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.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Ease of insertion
|
77.5 units on a scale
Standard Deviation 18.2
|
92.0 units on a scale
Standard Deviation 10.3
|
|
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Ease of removal
|
90.5 units on a scale
Standard Deviation 18.3
|
95.2 units on a scale
Standard Deviation 8.1
|
PRIMARY outcome
Timeframe: BaselinePopulation: 8 subjects discontinued the study.
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Outcome measures
| Measure |
Etafilcon A Lens
n=23 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
67.4 units on a scale
Standard Deviation 16.7
|
66.9 units on a scale
Standard Deviation 16.5
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study.
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
68.0 units on a scale
Standard Deviation 20.2
|
66.7 units on a scale
Standard Deviation 20.0
|
PRIMARY outcome
Timeframe: BaselinePopulation: 8 subjects discontinued the study.
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Outcome measures
| Measure |
Etafilcon A Lens
n=23 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=29 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
78.9 units on a scale
Standard Deviation 14.5
|
81.3 units on a scale
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.
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.
Outcome measures
| Measure |
Etafilcon A Lens
n=20 Participants
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
Hema-copolymer Lens
n=28 Participants
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
|---|---|---|
|
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
|
63.9 units on a scale
Standard Deviation 21.5
|
75.0 units on a scale
Standard Deviation 15.2
|
Adverse Events
Hema-copolymer Lens
Etafilcon A Lens
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hema-copolymer Lens
n=19 participants at risk
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens
|
Etafilcon A Lens
n=19 participants at risk
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens
|
|---|---|---|
|
Eye disorders
Unilateral red eye
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
Additional Information
Paul Chamberlain, BSc Honors, Sr. Manager Clinical Research
Coopervision
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER