Trial Outcomes & Findings for Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms (NCT NCT00761202)
NCT ID: NCT00761202
Last Updated: 2013-11-19
Results Overview
Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
week 1, month 1
Results posted on
2013-11-19
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose and Glycerin
|
Sodium Hyaluronate
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
28
|
|
Overall Study
COMPLETED
|
21
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose and Glycerin
n=21 Participants
|
Sodium Hyaluronate
n=26 Participants
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
44.8 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
42.0 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 1, month 1Population: Intent to Treat Population
Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin
n=21 Participants
|
Sodium Hyaluronate
n=26 Participants
|
|---|---|---|
|
Conjunctival Staining by Lissamine Green
Week 1 - None
|
50.0 Percentage of Participants
|
53.8 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Week 1 - Trace
|
17.5 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Week 1 - Mild
|
17.5 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Week 1 - Moderate
|
15.0 Percentage of Participants
|
5.8 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Week 1 - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Month 1 - None
|
78.6 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Month 1 - Trace
|
11.9 Percentage of Participants
|
17.3 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Month 1 - Mild
|
9.5 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Month 1 - Moderate
|
0.0 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Conjunctival Staining by Lissamine Green
Month 1 - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: week 1, month 1Population: Intent to Treat Population
Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin
n=21 Participants
|
Sodium Hyaluronate
n=26 Participants
|
|---|---|---|
|
Corneal Staining by Fluorescein
Week 1 - None
|
45.0 Percentage of Participants
|
57.7 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Week 1 - Trace
|
25.0 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Week 1 - Mild
|
15.0 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Week 1 - Moderate
|
15.0 Percentage of Participants
|
1.9 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Week 1 - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Month 1 - None
|
73.8 Percentage of Participants
|
51.9 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Month 1 - Trace
|
21.4 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Month 1 - Mild
|
4.8 Percentage of Participants
|
26.9 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Month 1 - Moderate
|
0.0 Percentage of Participants
|
5.8 Percentage of Participants
|
|
Corneal Staining by Fluorescein
Month 1 - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: week 1, month 1Population: Intent to Treat Population
Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin
n=21 Participants
|
Sodium Hyaluronate
n=26 Participants
|
|---|---|---|
|
Conjunctival Hyperaemia
Week 1 - Clear/White
|
5.0 Percentage of Participants
|
3.8 Percentage of Participants
|
|
Conjunctival Hyperaemia
Week 1 - Slight
|
75.0 Percentage of Participants
|
59.6 Percentage of Participants
|
|
Conjunctival Hyperaemia
Week 1 - Mild
|
17.5 Percentage of Participants
|
36.5 Percentage of Participants
|
|
Conjunctival Hyperaemia
Week 1 - Moderate
|
2.5 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Conjunctival Hyperaemia
Week 1 - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Conjunctival Hyperaemia
Month 1 - Clear/White
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Conjunctival Hyperaemia
Month 1 - Slight
|
71.4 Percentage of Participants
|
71.2 Percentage of Participants
|
|
Conjunctival Hyperaemia
Month 1 - Mild
|
28.6 Percentage of Participants
|
28.8 Percentage of Participants
|
|
Conjunctival Hyperaemia
Month 1 - Moderate
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Conjunctival Hyperaemia
Month 1 - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: week 1, month 1Population: Intent to Treat Population
Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin
n=21 Participants
|
Sodium Hyaluronate
n=26 Participants
|
|---|---|---|
|
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Ocular Comfort - Waking (Wk.1)
|
67.05 Units on a scale
Standard Deviation 24.90
|
58.81 Units on a scale
Standard Deviation 24.73
|
|
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Ocular Comfort - Daytime (Wk.1)
|
63.20 Units on a scale
Standard Deviation 22.05
|
68.21 Units on a scale
Standard Deviation 19.48
|
|
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Ocular Comfort - Evening (Wk.1)
|
57.15 Units on a scale
Standard Deviation 26.30
|
63.38 Units on a scale
Standard Deviation 23.71
|
|
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Ocular Comfort - Waking (Mo.1)
|
65.05 Units on a scale
Standard Deviation 23.48
|
63.56 Units on a scale
Standard Deviation 28.79
|
|
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Ocular Comfort - Daytime (Mo.1)
|
68.57 Units on a scale
Standard Deviation 17.25
|
70.48 Units on a scale
Standard Deviation 23.21
|
|
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Ocular Comfort - Evening (Mo.1)
|
60.38 Units on a scale
Standard Deviation 23.29
|
65.06 Units on a scale
Standard Deviation 23.44
|
SECONDARY outcome
Timeframe: Month 1Population: Intent to Treat Population
Average daily eyedrop use
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin
n=21 Participants
|
Sodium Hyaluronate
n=26 Participants
|
|---|---|---|
|
Daily Eyedrop Usage
|
3.7 drops/day
Standard Deviation 1.4
|
3.3 drops/day
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 1, month 1Population: Intent to Treat Population
Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin
n=21 Participants
|
Sodium Hyaluronate
n=26 Participants
|
|---|---|---|
|
Lipid Layer Pattern Assessment
Week 1
|
4.50 Lipid Layer Mixing Pattern
Interval 0.0 to 12.0
|
5.50 Lipid Layer Mixing Pattern
Interval 1.0 to 10.0
|
|
Lipid Layer Pattern Assessment
Month 1
|
3.00 Lipid Layer Mixing Pattern
Interval 1.0 to 10.0
|
5.00 Lipid Layer Mixing Pattern
Interval 1.0 to 12.0
|
Adverse Events
Carboxymethylcellulose and Glycerin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sodium Hyaluronate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carboxymethylcellulose and Glycerin
n=21 participants at risk
|
Sodium Hyaluronate
n=26 participants at risk
|
|---|---|---|
|
Eye disorders
Upper Lid Cyst
|
0.00%
0/21
|
3.8%
1/26
|
|
Eye disorders
Mild Corneal Toxicity
|
4.8%
1/21
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Foot Injury
|
4.8%
1/21
|
0.00%
0/26
|
Additional Information
Vice President Medical Affairs - Europe
Allergan, Inc.
Phone: (714)246-4500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60