Trial Outcomes & Findings for Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects (NCT NCT01010282)
NCT ID: NCT01010282
Last Updated: 2015-08-17
Results Overview
Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.
COMPLETED
NA
288 participants
Baseline (Day 1), Day 90
2015-08-17
Participant Flow
Participant milestones
| Measure |
Artificial Tears Formulation 1
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Overall Study
STARTED
|
97
|
95
|
96
|
|
Overall Study
COMPLETED
|
91
|
88
|
77
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
Baseline characteristics by cohort
| Measure |
Artificial Tears Formulation 1
n=97 Participants
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
n=95 Participants
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=96 Participants
Glycerin and Polysorbate 80 based artificial tear
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<30 years
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Age, Customized
between 30 and 40 years
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
11 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Age, Customized
>40 years
|
85 participants
n=5 Participants
|
77 participants
n=7 Participants
|
81 participants
n=5 Participants
|
243 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 90Population: Intent-to-treat, which includes all patients who started the study (randomized).
Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.
Outcome measures
| Measure |
Artificial Tears Formulation 1
n=97 Participants
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
n=95 Participants
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=96 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
Baseline (Day 1)
|
2.7 Scores on a Scale
Standard Deviation 0.59
|
2.8 Scores on a Scale
Standard Deviation 0.67
|
2.8 Scores on a Scale
Standard Deviation 0.65
|
|
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
Change from Baseline at Day 90
|
-0.7 Scores on a Scale
Standard Deviation 0.89
|
-0.7 Scores on a Scale
Standard Deviation 0.90
|
-0.7 Scores on a Scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 90Population: Intent-to-treat, which includes all patients who started the study (randomized).
Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Outcome measures
| Measure |
Artificial Tears Formulation 1
n=97 Participants
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
n=95 Participants
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=96 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90
Baseline (Day 1)
|
33.6 Scores on a Scale
Standard Deviation 20.19
|
35.1 Scores on a Scale
Standard Deviation 19.18
|
37.3 Scores on a Scale
Standard Deviation 18.67
|
|
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90
Change from Baseline at Day 90
|
-7.2 Scores on a Scale
Standard Deviation 19.47
|
-10.6 Scores on a Scale
Standard Deviation 18.43
|
-9.1 Scores on a Scale
Standard Deviation 19.68
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 90Population: Intent-to-treat, which includes all patients who started the study (randomized).
Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).
Outcome measures
| Measure |
Artificial Tears Formulation 1
n=97 Participants
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
n=95 Participants
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=96 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Change From Baseline in Tear Break-up Time (TBUT) at Day 90
Change from Baseline at Day 90
|
1.49 Seconds
Standard Deviation 2.955
|
2.02 Seconds
Standard Deviation 3.812
|
1.81 Seconds
Standard Deviation 3.464
|
|
Change From Baseline in Tear Break-up Time (TBUT) at Day 90
Baseline (Day 1)
|
4.90 Seconds
Standard Deviation 1.768
|
5.04 Seconds
Standard Deviation 1.653
|
5.09 Seconds
Standard Deviation 1.782
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 90Population: Intent-to-treat, which includes all patients who started the study (randomized).
Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).
Outcome measures
| Measure |
Artificial Tears Formulation 1
n=97 Participants
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
n=95 Participants
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=96 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Change From Baseline in Corneal Staining at Day 90
Baseline (Day 1)
|
4.2 Scores on a scale
Standard Deviation 3.14
|
4.2 Scores on a scale
Standard Deviation 2.91
|
4.5 Scores on a scale
Standard Deviation 3.15
|
|
Change From Baseline in Corneal Staining at Day 90
Change from Baseline at Day 90
|
0.2 Scores on a scale
Standard Deviation 3.35
|
-0.5 Scores on a scale
Standard Deviation 3.01
|
0.8 Scores on a scale
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 90Population: Intent-to-treat, which includes all patients who started the study (randomized).
Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).
Outcome measures
| Measure |
Artificial Tears Formulation 1
n=97 Participants
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
n=95 Participants
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=96 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Change From Baseline in Conjunctival Staining Severity Score at Day 90
Change from Baseline at Day 90
|
-0.5 Scores on a scale
Standard Deviation 4.17
|
-0.7 Scores on a scale
Standard Deviation 4.53
|
-0.7 Scores on a scale
Standard Deviation 3.89
|
|
Change From Baseline in Conjunctival Staining Severity Score at Day 90
Baseline (Day 1)
|
5.1 Scores on a scale
Standard Deviation 4.71
|
4.9 Scores on a scale
Standard Deviation 4.37
|
5.2 Scores on a scale
Standard Deviation 4.95
|
Adverse Events
Artificial Tears Formulation 1
Artificial Tears Formulation 2
Glycerin and Polysorbate 80 Based Artificial Tear
Serious adverse events
| Measure |
Artificial Tears Formulation 1
n=97 participants at risk
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
n=95 participants at risk
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=96 participants at risk
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Surgical and medical procedures
Abortion induced
|
1.0%
1/97
|
0.00%
0/95
|
0.00%
0/96
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/97
|
0.00%
0/95
|
0.00%
0/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/97
|
0.00%
0/95
|
1.0%
1/96
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/97
|
0.00%
0/95
|
1.0%
1/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/97
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/97
|
0.00%
0/95
|
1.0%
1/96
|
Other adverse events
| Measure |
Artificial Tears Formulation 1
n=97 participants at risk
Artificial Tears Formulation 1
|
Artificial Tears Formulation 2
n=95 participants at risk
Artificial Tears Formulation 2
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=96 participants at risk
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
16.5%
16/97
|
7.4%
7/95
|
11.5%
11/96
|
|
Eye disorders
Vision blurred
|
5.2%
5/97
|
3.2%
3/95
|
7.3%
7/96
|
|
Eye disorders
Eye pain
|
3.1%
3/97
|
1.1%
1/95
|
6.2%
6/96
|
|
Eye disorders
Photophobia
|
3.1%
3/97
|
1.1%
1/95
|
5.2%
5/96
|
|
General disorders
Instillation site pain
|
1.0%
1/97
|
2.1%
2/95
|
8.3%
8/96
|
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 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