Trial Outcomes & Findings for Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye (NCT NCT00514852)
NCT ID: NCT00514852
Last Updated: 2009-12-15
Results Overview
Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
316 participants
Primary outcome timeframe
Change from baseline at Day 30
Results posted on
2009-12-15
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
159
|
|
Overall Study
COMPLETED
|
152
|
154
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<40 years
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Age, Customized
>=40 years
|
139 participants
n=5 Participants
|
144 participants
n=7 Participants
|
283 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at Day 30Population: Intent to Treat Population (Modified)
Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=147 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=154 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
Day 1 (Baseline)
|
44 Units on a scale
Standard Deviation 18.1
|
45.2 Units on a scale
Standard Deviation 18.3
|
|
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
Day 7
|
-12.6 Units on a scale
Standard Deviation 14.9
|
-13.6 Units on a scale
Standard Deviation 17.8
|
|
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
Day 30
|
-16.3 Units on a scale
Standard Deviation 16.4
|
-16.6 Units on a scale
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: Change from baseline at Day 30Population: Intent to Treat Population
Schirmer Test measures the rate of the secretion of tears
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Day 1 (Baseline)
|
9.2 mm/5min
Standard Deviation 7.2
|
8.6 mm/5min
Standard Deviation 6.8
|
|
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Day 7
|
1.2 mm/5min
Standard Deviation 5.1
|
1.2 mm/5min
Standard Deviation 5.6
|
|
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Day 30
|
1.7 mm/5min
Standard Deviation 6.9
|
1.8 mm/5min
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Change from baseline at Day 30Population: Intent to Treat Population
Measures the stability of tear film. The average of 3 measures.
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Day 1 (Baseline)
|
4.3 seconds
Standard Deviation 2.1
|
4.3 seconds
Standard Deviation 2.0
|
|
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Day 7
|
0.9 seconds
Standard Deviation 2.3
|
0.9 seconds
Standard Deviation 2.1
|
|
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Day 30
|
1.1 seconds
Standard Deviation 2.7
|
0.9 seconds
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Day 30Population: Intent to Treat Population
Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Patient Acceptability Score (Dryness) at Day 30
Day 1 (Baseline)
|
47.4 Units on scale
Standard Deviation 22.8
|
44.6 Units on scale
Standard Deviation 20.5
|
|
Patient Acceptability Score (Dryness) at Day 30
Day 7
|
60.7 Units on scale
Standard Deviation 21.1
|
57.7 Units on scale
Standard Deviation 22.5
|
|
Patient Acceptability Score (Dryness) at Day 30
Day 30
|
63.3 Units on scale
Standard Deviation 22.7
|
63.8 Units on scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: Day 30Population: Intent to treat population
Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Patient Acceptability Score (Vision) at Day 30
Day 1 (Baseline)
|
56.8 Units on a scale
Standard Deviation 22.4
|
54.2 Units on a scale
Standard Deviation 21.6
|
|
Patient Acceptability Score (Vision) at Day 30
Day 7
|
65.3 Units on a scale
Standard Deviation 17.8
|
62.6 Units on a scale
Standard Deviation 19.6
|
|
Patient Acceptability Score (Vision) at Day 30
Day 30
|
65.4 Units on a scale
Standard Deviation 20.1
|
66.4 Units on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: Change from baseline at Day 30Population: Intent to Treat Population
Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
Day 1 (Baseline)
|
4.0 Units on a scale
Standard Deviation 3.3
|
4.4 Units on a scale
Standard Deviation 3.4
|
|
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
Day 7
|
-1.2 Units on a scale
Standard Deviation 2.3
|
-0.9 Units on a scale
Standard Deviation 2.4
|
|
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
Day 30
|
-1.3 Units on a scale
Standard Deviation 2.4
|
-1.5 Units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Change from baseline at Day 30Population: Intent to Treat Population
Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
Day 1 (Baseline)
|
4.9 Units on a scale
Standard Deviation 4.4
|
5.1 Units on a scale
Standard Deviation 5.0
|
|
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
Day 7
|
-1.1 Units on a scale
Standard Deviation 3.1
|
-1.0 Units on a scale
Standard Deviation 3.2
|
|
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
Day 30
|
-1.7 Units on a scale
Standard Deviation 3.3
|
-1.5 Units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Change from baseline at Day 30Population: Intent to Treat Population
Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Day 1 (Baseline)
|
2.8 Units on a scale
Standard Deviation 0.7
|
2.8 Units on a scale
Standard Deviation 0.8
|
|
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Day 7
|
-0.5 Units on a scale
Standard Deviation 0.8
|
-0.5 Units on a scale
Standard Deviation 0.8
|
|
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Day 30
|
-0.7 Units on a scale
Standard Deviation 1.0
|
-0.7 Units on a scale
Standard Deviation 0.9
|
POST_HOC outcome
Timeframe: Day 30Population: Intent to Treat Population (Modified)
Vision subscale of the Ocular Surface Disease Index Questionnaire© is measured on 6 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=147 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=154 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30
Day 1 (Baseline)
|
37.6 Units on a scale
Standard Deviation 21.5
|
41.6 Units on a scale
Standard Deviation 21.6
|
|
Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30
Day 7
|
24.8 Units on a scale
Standard Deviation 20.0
|
26.9 Units on a scale
Standard Deviation 20.2
|
|
Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30
Day 30
|
22.8 Units on a scale
Standard Deviation 20.4
|
25.6 Units on a scale
Standard Deviation 22.4
|
POST_HOC outcome
Timeframe: Day 30Population: Intent to Treat Population
Central staining score is based on modified Oxford Scheme measured on a scale of 0-5 (0= no staining, 5= most severe staining)
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 Participants
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30
Day 30
|
0.4 Units on a scale
Standard Deviation 0.6
|
0.4 Units on a scale
Standard Deviation 0.7
|
|
Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30
Day 1 (Baseline)
|
0.7 Units on a scale
Standard Deviation 0.8
|
0.8 Units on a scale
Standard Deviation 0.8
|
|
Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30
Day 7
|
0.5 Units on a scale
Standard Deviation 0.7
|
0.5 Units on a scale
Standard Deviation 0.7
|
Adverse Events
Carboxymethylcellulose and Glycerin Based Artificial Tear
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Carboxymethylcellulose Based Artificial Tear
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=157 participants at risk
1 to 2 drops into each eye as needed but at least twice daily
|
Carboxymethylcellulose Based Artificial Tear
n=159 participants at risk
1 to 2 drops into each eye as needed but at least twice daily
|
|---|---|---|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.64%
1/157
|
0.00%
0/159
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/157
|
0.63%
1/159
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER