Dry Eye Syndromes
Conditions
Brief summary
Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.
Interventions
DRUGLubricant Eye Drops (Optive™)
1 drop in both eyes as needed for 7 days'
DRUGLubricating Eye Drops (blink® Tears)
1 drop in both eyes as needed for 7 days
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female * At least 18 years of age * Current use of artificial tears
Exclusion criteria
* Any uncontrolled systemic disease * Pregnancy or planning a pregnancy * Contact lens wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Frequency of Eye Drop Use Over 1 Week | 1 week | Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 | Baseline, Day 16 | Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort. |
| Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16 | Day 16 | Percentage of patients who responded Strongly Agree and Agree to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are Strongly Agree, Agree, Neither Agree or Disagree, Disagree and Strongly Disagree. |
| Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16 | Day 16 | Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Customized <=40 years | 22 participants |
| Age, Customized >=65 years | 5 participants |
| Age, Customized Between 40 and 65 years | 24 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Mean Frequency of Eye Drop Use Over 1 Week
Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.
Time frame: 1 week
Population: Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubricant Eye Drops (Optive™) | Mean Frequency of Eye Drop Use Over 1 Week | 1.76 Use per day | Standard Deviation 0.89921 |
| Lubricant Eye Drops (Blink® Tears) | Mean Frequency of Eye Drop Use Over 1 Week | 1.66 Use per day | Standard Deviation 0.94459 |
Secondary
Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16
Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.
Time frame: Baseline, Day 16
Population: Intent to Treat; defined as all randomized (started study) patients. Of the 51 randomized patients, data from 49 patients were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricant Eye Drops (Optive™) | Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 | Baseline | 4.65 Scores on a scale | Standard Deviation 1.843 |
| Lubricant Eye Drops (Optive™) | Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 | Day 16 | -1.41 Scores on a scale | Standard Deviation 2.01 |
| Lubricant Eye Drops (Blink® Tears) | Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 | Baseline | 4.62 Scores on a scale | Standard Deviation 1.839 |
| Lubricant Eye Drops (Blink® Tears) | Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 | Day 16 | -1.47 Scores on a scale | Standard Deviation 1.905 |
Secondary
Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16
Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.
Time frame: Day 16
Population: Intent to Treat; defined as all randomized (started study) patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lubricant Eye Drops (Optive™) | Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16 | 16 Number of patients |
| Lubricant Eye Drops (Blink® Tears) | Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16 | 22 Number of patients |
Secondary
Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16
Percentage of patients who responded Strongly Agree and Agree to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are Strongly Agree, Agree, Neither Agree or Disagree, Disagree and Strongly Disagree.
Time frame: Day 16
Population: Intent to treat; defined as all randomized (started study)patients. Of the 51 randomized patients, data for 50 patients were evaluated for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lubricant Eye Drops (Optive™) | Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16 | 86 Percentage of Patients |
| Lubricant Eye Drops (Blink® Tears) | Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16 | 78 Percentage of Patients |