Trial Outcomes & Findings for Safety and Tolerability of Artificial Tears in Dry Eye Subjects (NCT NCT00932477)
NCT ID: NCT00932477
Last Updated: 2015-08-26
Results Overview
Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.
COMPLETED
NA
47 participants
1 Week
2015-08-26
Participant Flow
This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 products in a randomly assigned order. The subject used 1 product at a time for a duration of 1 week before switching to the next assigned product (e.g., with treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA).
Participant milestones
| Measure |
Sequence ABC
Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
|
Sequence ACB
Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
|
Sequence BAC
Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
|
Sequence BCA
Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1
|
Sequence CAB
Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2
|
Sequence CBA
Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1
|
|---|---|---|---|---|---|---|
|
Treatment 1
STARTED
|
7
|
8
|
9
|
7
|
8
|
8
|
|
Treatment 1
COMPLETED
|
7
|
8
|
9
|
7
|
8
|
8
|
|
Treatment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment 2
STARTED
|
7
|
8
|
9
|
7
|
8
|
8
|
|
Treatment 2
COMPLETED
|
7
|
8
|
9
|
7
|
8
|
8
|
|
Treatment 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment 3
STARTED
|
7
|
8
|
9
|
7
|
8
|
8
|
|
Treatment 3
COMPLETED
|
7
|
8
|
9
|
7
|
8
|
8
|
|
Treatment 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of Artificial Tears in Dry Eye Subjects
Baseline characteristics by cohort
| Measure |
All Study Participants
n=47 Participants
All Study Participants
|
|---|---|
|
Age, Customized
<40 years
|
7 participants
n=5 Participants
|
|
Age, Customized
>=40 years
|
40 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 WeekPopulation: Safety population, which consisted of all patients who started the study (randomized) and received treatment.
Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.
Outcome measures
| Measure |
Artificial Tear Formulation 1
n=47 Participants
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
|
Artificial Tear Formulation 2
n=47 Participants
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=47 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Tolerability Questionnaire Mean Scores at 1 Week
How comfortable is drop in the eye?
|
70.1 Scores on a scale
Standard Deviation 30.01
|
70.7 Scores on a scale
Standard Deviation 26.63
|
57.3 Scores on a scale
Standard Deviation 31.40
|
|
Tolerability Questionnaire Mean Scores at 1 Week
How soothing is drop in the eye?
|
65.1 Scores on a scale
Standard Deviation 31.67
|
65.9 Scores on a scale
Standard Deviation 27.68
|
53.4 Scores on a scale
Standard Deviation 32.63
|
|
Tolerability Questionnaire Mean Scores at 1 Week
How moistening/lubricating is drop in the eye?
|
68.0 Scores on a scale
Standard Deviation 27.79
|
65.9 Scores on a scale
Standard Deviation 28.41
|
57.4 Scores on a scale
Standard Deviation 31.51
|
|
Tolerability Questionnaire Mean Scores at 1 Week
How clear is vision with drop in the eye?
|
66.0 Scores on a scale
Standard Deviation 30.91
|
61.1 Scores on a scale
Standard Deviation 30.78
|
53.0 Scores on a scale
Standard Deviation 30.87
|
|
Tolerability Questionnaire Mean Scores at 1 Week
How much stickiness with drop in the eye?
|
24.6 Scores on a scale
Standard Deviation 29.44
|
19.5 Scores on a scale
Standard Deviation 23.82
|
31.4 Scores on a scale
Standard Deviation 29.03
|
|
Tolerability Questionnaire Mean Scores at 1 Week
How much blur with drop in the eye?
|
33.2 Scores on a scale
Standard Deviation 29.88
|
32.4 Scores on a scale
Standard Deviation 30.52
|
48.9 Scores on a scale
Standard Deviation 30.83
|
|
Tolerability Questionnaire Mean Scores at 1 Week
How much burning/stinging with drop in the eye?
|
14.8 Scores on a scale
Standard Deviation 22.48
|
14.3 Scores on a scale
Standard Deviation 22.40
|
27.9 Scores on a scale
Standard Deviation 30.62
|
|
Tolerability Questionnaire Mean Scores at 1 Week
How much discomfort with drop in the eye?
|
19.3 Scores on a scale
Standard Deviation 24.84
|
18.9 Scores on a scale
Standard Deviation 26.27
|
27.1 Scores on a scale
Standard Deviation 28.57
|
SECONDARY outcome
Timeframe: 1 WeekPopulation: Safety population, which consisted of all patients who started the study (randomized) and received treatment.
Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.
Outcome measures
| Measure |
Artificial Tear Formulation 1
n=47 Participants
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
|
Artificial Tear Formulation 2
n=47 Participants
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=47 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
Pterygium (cornea)
|
1 Number of Patients
|
0 Number of Patients
|
0 Number of Patients
|
|
Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
Punctate keratitis (cornea)
|
0 Number of Patients
|
1 Number of Patients
|
2 Number of Patients
|
|
Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
Vital dye staining of cornea present
|
0 Number of Patients
|
1 Number of Patients
|
0 Number of Patients
|
SECONDARY outcome
Timeframe: 1 WeekPopulation: Safety population, which consisted of all patients who started the study (randomized) and received treatment.
BCVA status at 1 week reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more in at least 1 eye; "No Change" equals change between -2 to +2 lines in either eye; "Worse" equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly.
Outcome measures
| Measure |
Artificial Tear Formulation 1
n=47 Participants
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
|
Artificial Tear Formulation 2
n=47 Participants
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=47 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
Best-Corrected Visual Acuity (BCVA) Status at 1 Week
Better
|
0 Number of Patients
|
0 Number of Patients
|
0 Number of Patients
|
|
Best-Corrected Visual Acuity (BCVA) Status at 1 Week
No Change
|
46 Number of Patients
|
45 Number of Patients
|
46 Number of Patients
|
|
Best-Corrected Visual Acuity (BCVA) Status at 1 Week
Worse
|
1 Number of Patients
|
2 Number of Patients
|
1 Number of Patients
|
SECONDARY outcome
Timeframe: 1 WeekPopulation: Safety population, which consisted of all patients who started the study (randomized) and received treatment.
The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product
Outcome measures
| Measure |
Artificial Tear Formulation 1
n=47 Participants
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
|
Artificial Tear Formulation 2
n=47 Participants
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
|
Glycerin and Polysorbate 80 Based Artificial Tear
n=47 Participants
Glycerin and Polysorbate 80 based artificial tear
|
|---|---|---|---|
|
The Number of Ophthalmic Adverse Events at 1 Week
Eye pruritis (itching)
|
0 Number of adverse events
|
0 Number of adverse events
|
2 Number of adverse events
|
|
The Number of Ophthalmic Adverse Events at 1 Week
Abnormal sensation in eye
|
0 Number of adverse events
|
0 Number of adverse events
|
1 Number of adverse events
|
|
The Number of Ophthalmic Adverse Events at 1 Week
Erythema (redness) of eyelid
|
0 Number of adverse events
|
0 Number of adverse events
|
1 Number of adverse events
|
|
The Number of Ophthalmic Adverse Events at 1 Week
Eyelid irritation
|
0 Number of adverse events
|
0 Number of adverse events
|
1 Number of adverse events
|
Adverse Events
Artificial Tear Formulation 1
Artificial Tear Formulation 2
Glycerin and Polysorbate 80 Based Artificial Tear
Serious adverse events
Adverse event data not reported
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 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