Dry Eye Syndrome
Conditions
Brief summary
The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.
Interventions
DRUGFormulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
1 to 2 drops into each eye three times per day
DRUGFormulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
1 to 2 drops into each eye three times per day
1 to 2 drops into each eye three times per day
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild, moderate or severe symptoms of dry eye
Exclusion criteria
* Uncontrolled systemic disease * Contact lens wear * Participation in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Questionnaire Mean Scores at 1 Week | 1 Week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | 1 Week | 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. |
| Best-Corrected Visual Acuity (BCVA) Status at 1 Week | 1 Week | 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. |
| The Number of Ophthalmic Adverse Events at 1 Week | 1 Week | 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 |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All Study Participants | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Customized <40 years | 7 participants |
| Age, Customized >=40 years | 40 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 | 0 / 47 |
Outcome results
Primary
Tolerability Questionnaire Mean Scores at 1 Week
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.
Time frame: 1 Week
Population: Safety population, which consisted of all patients who started the study (randomized) and received treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Artificial Tear Formulation 1 | 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 |
| Artificial Tear Formulation 1 | 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 |
| Artificial Tear Formulation 1 | 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 |
| Artificial Tear Formulation 1 | 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 |
| Artificial Tear Formulation 1 | Tolerability Questionnaire Mean Scores at 1 Week | How soothing is drop in the eye? | 65.1 Scores on a scale | Standard Deviation 31.67 |
| Artificial Tear Formulation 1 | 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 |
| Artificial Tear Formulation 1 | 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 |
| Artificial Tear Formulation 1 | Tolerability Questionnaire Mean Scores at 1 Week | How comfortable is drop in the eye? | 70.1 Scores on a scale | Standard Deviation 30.01 |
| Artificial Tear Formulation 2 | Tolerability Questionnaire Mean Scores at 1 Week | How soothing is drop in the eye? | 65.9 Scores on a scale | Standard Deviation 27.68 |
| Artificial Tear Formulation 2 | Tolerability Questionnaire Mean Scores at 1 Week | How comfortable is drop in the eye? | 70.7 Scores on a scale | Standard Deviation 26.63 |
| Artificial Tear Formulation 2 | Tolerability Questionnaire Mean Scores at 1 Week | How moistening/lubricating is drop in the eye? | 65.9 Scores on a scale | Standard Deviation 28.41 |
| Artificial Tear Formulation 2 | Tolerability Questionnaire Mean Scores at 1 Week | How clear is vision with drop in the eye? | 61.1 Scores on a scale | Standard Deviation 30.78 |
| Artificial Tear Formulation 2 | Tolerability Questionnaire Mean Scores at 1 Week | How much stickiness with drop in the eye? | 19.5 Scores on a scale | Standard Deviation 23.82 |
| Artificial Tear Formulation 2 | Tolerability Questionnaire Mean Scores at 1 Week | How much blur with drop in the eye? | 32.4 Scores on a scale | Standard Deviation 30.52 |
| Artificial Tear Formulation 2 | Tolerability Questionnaire Mean Scores at 1 Week | How much burning/stinging with drop in the eye? | 14.3 Scores on a scale | Standard Deviation 22.4 |
| Artificial Tear Formulation 2 | Tolerability Questionnaire Mean Scores at 1 Week | How much discomfort with drop in the eye? | 18.9 Scores on a scale | Standard Deviation 26.27 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Tolerability Questionnaire Mean Scores at 1 Week | How comfortable is drop in the eye? | 57.3 Scores on a scale | Standard Deviation 31.4 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Tolerability Questionnaire Mean Scores at 1 Week | How much blur with drop in the eye? | 48.9 Scores on a scale | Standard Deviation 30.83 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Tolerability Questionnaire Mean Scores at 1 Week | How soothing is drop in the eye? | 53.4 Scores on a scale | Standard Deviation 32.63 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Tolerability Questionnaire Mean Scores at 1 Week | How much discomfort with drop in the eye? | 27.1 Scores on a scale | Standard Deviation 28.57 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Tolerability Questionnaire Mean Scores at 1 Week | How clear is vision with drop in the eye? | 53.0 Scores on a scale | Standard Deviation 30.87 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Tolerability Questionnaire Mean Scores at 1 Week | How much burning/stinging with drop in the eye? | 27.9 Scores on a scale | Standard Deviation 30.62 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Tolerability Questionnaire Mean Scores at 1 Week | How much stickiness with drop in the eye? | 31.4 Scores on a scale | Standard Deviation 29.03 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Tolerability Questionnaire Mean Scores at 1 Week | How moistening/lubricating is drop in the eye? | 57.4 Scores on a scale | Standard Deviation 31.51 |
Secondary
Best-Corrected Visual Acuity (BCVA) Status at 1 Week
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.
Time frame: 1 Week
Population: Safety population, which consisted of all patients who started the study (randomized) and received treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Artificial Tear Formulation 1 | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | No Change | 46 Number of Patients |
| Artificial Tear Formulation 1 | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | Better | 0 Number of Patients |
| Artificial Tear Formulation 1 | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | Worse | 1 Number of Patients |
| Artificial Tear Formulation 2 | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | No Change | 45 Number of Patients |
| Artificial Tear Formulation 2 | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | Better | 0 Number of Patients |
| Artificial Tear Formulation 2 | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | Worse | 2 Number of Patients |
| Glycerin and Polysorbate 80 Based Artificial Tear | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | Better | 0 Number of Patients |
| Glycerin and Polysorbate 80 Based Artificial Tear | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | Worse | 1 Number of Patients |
| Glycerin and Polysorbate 80 Based Artificial Tear | Best-Corrected Visual Acuity (BCVA) Status at 1 Week | No Change | 46 Number of Patients |
Secondary
Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
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.
Time frame: 1 Week
Population: Safety population, which consisted of all patients who started the study (randomized) and received treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Artificial Tear Formulation 1 | Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Pterygium (cornea) | 1 Number of Patients |
| Artificial Tear Formulation 1 | 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 |
| Artificial Tear Formulation 1 | Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Punctate keratitis (cornea) | 0 Number of Patients |
| Artificial Tear Formulation 2 | Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Pterygium (cornea) | 0 Number of Patients |
| Artificial Tear Formulation 2 | Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Punctate keratitis (cornea) | 1 Number of Patients |
| Artificial Tear Formulation 2 | Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Vital dye staining of cornea present | 1 Number of Patients |
| 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) | 0 Number of Patients |
| Glycerin and Polysorbate 80 Based Artificial Tear | 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 |
| Glycerin and Polysorbate 80 Based Artificial Tear | Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Punctate keratitis (cornea) | 2 Number of Patients |
Secondary
The Number of Ophthalmic Adverse Events at 1 Week
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
Time frame: 1 Week
Population: Safety population, which consisted of all patients who started the study (randomized) and received treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Artificial Tear Formulation 1 | The Number of Ophthalmic Adverse Events at 1 Week | Eye pruritis (itching) | 0 Number of adverse events |
| Artificial Tear Formulation 1 | The Number of Ophthalmic Adverse Events at 1 Week | Abnormal sensation in eye | 0 Number of adverse events |
| Artificial Tear Formulation 1 | The Number of Ophthalmic Adverse Events at 1 Week | Erythema (redness) of eyelid | 0 Number of adverse events |
| Artificial Tear Formulation 1 | The Number of Ophthalmic Adverse Events at 1 Week | Eyelid irritation | 0 Number of adverse events |
| Artificial Tear Formulation 2 | The Number of Ophthalmic Adverse Events at 1 Week | Eyelid irritation | 0 Number of adverse events |
| Artificial Tear Formulation 2 | The Number of Ophthalmic Adverse Events at 1 Week | Eye pruritis (itching) | 0 Number of adverse events |
| Artificial Tear Formulation 2 | The Number of Ophthalmic Adverse Events at 1 Week | Erythema (redness) of eyelid | 0 Number of adverse events |
| Artificial Tear Formulation 2 | The Number of Ophthalmic Adverse Events at 1 Week | Abnormal sensation in eye | 0 Number of adverse events |
| Glycerin and Polysorbate 80 Based Artificial Tear | The Number of Ophthalmic Adverse Events at 1 Week | Eyelid irritation | 1 Number of adverse events |
| Glycerin and Polysorbate 80 Based Artificial Tear | The Number of Ophthalmic Adverse Events at 1 Week | Abnormal sensation in eye | 1 Number of adverse events |
| Glycerin and Polysorbate 80 Based Artificial Tear | The Number of Ophthalmic Adverse Events at 1 Week | Erythema (redness) of eyelid | 1 Number of adverse events |
| Glycerin and Polysorbate 80 Based Artificial Tear | The Number of Ophthalmic Adverse Events at 1 Week | Eye pruritis (itching) | 2 Number of adverse events |