Dry Eye Syndrome
Conditions
Brief summary
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear
Interventions
1 to 2 drops into each eye as needed but at least twice daily
1 to 2 drops into each eye as needed but at least twice daily
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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 * Use of systemic medications affecting dry eye * Pregnancy or planning a pregnancy * Contact lens wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Change from baseline at Day 30 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Change from baseline at Day 30 | Measures the stability of tear film. The average of 3 measures. |
| Patient Acceptability Score (Dryness) at Day 30 | Day 30 | Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all). |
| Patient Acceptability Score (Vision) at Day 30 | Day 30 | 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). |
| Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Change from baseline at Day 30 | Schirmer Test measures the rate of the secretion of tears |
| Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Change from baseline at Day 30 | 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) |
| Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score | Change from baseline at Day 30 | Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe) |
| Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Change from baseline at Day 30 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear 1 to 2 drops into each eye as needed but at least twice daily | 157 |
| Carboxymethylcellulose Based Artificial Tear 1 to 2 drops into each eye as needed but at least twice daily | 159 |
| Total | 316 |
Baseline characteristics
| Characteristic | Carboxymethylcellulose and Glycerin Based Artificial Tear | Carboxymethylcellulose Based Artificial Tear | Total |
|---|---|---|---|
| Age, Customized <40 years | 18 participants | 15 participants | 33 participants |
| Age, Customized >=40 years | 139 participants | 144 participants | 283 participants |
| Sex: Female, Male Female | 120 Participants | 125 Participants | 245 Participants |
| Sex: Female, Male Male | 37 Participants | 34 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 157 | 0 / 159 |
| serious Total, serious adverse events | 1 / 157 | 1 / 159 |
Outcome results
Primary
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
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)
Time frame: Change from baseline at Day 30
Population: Intent to Treat Population (Modified)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Day 30 | -16.6 Units on a scale | Standard Deviation 20.3 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Day 1 (Baseline) | 45.2 Units on a scale | Standard Deviation 18.3 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Day 7 | -13.6 Units on a scale | Standard Deviation 17.8 |
Secondary
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
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)
Time frame: Change from baseline at Day 30
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Day 1 (Baseline) | 5.1 Units on a scale | Standard Deviation 5 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Day 7 | -1.0 Units on a scale | Standard Deviation 3.2 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Day 30 | -1.5 Units on a scale | Standard Deviation 2.8 |
Secondary
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
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)
Time frame: Change from baseline at Day 30
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Day 1 (Baseline) | 4.4 Units on a scale | Standard Deviation 3.4 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Day 7 | -0.9 Units on a scale | Standard Deviation 2.4 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Day 30 | -1.5 Units on a scale | Standard Deviation 2.5 |
Secondary
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Schirmer Test measures the rate of the secretion of tears
Time frame: Change from baseline at Day 30
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Day 1 (Baseline) | 9.2 mm/5min | Standard Deviation 7.2 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Day 7 | 1.2 mm/5min | Standard Deviation 5.1 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Day 30 | 1.7 mm/5min | Standard Deviation 6.9 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Day 1 (Baseline) | 8.6 mm/5min | Standard Deviation 6.8 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Day 7 | 1.2 mm/5min | Standard Deviation 5.6 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Day 30 | 1.8 mm/5min | Standard Deviation 7.3 |
Secondary
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)
Time frame: Change from baseline at Day 30
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose Based Artificial Tear | 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 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score | Day 30 | -0.7 Units on a scale | Standard Deviation 0.9 |
| Carboxymethylcellulose Based Artificial Tear | 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 0.8 |
Secondary
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Measures the stability of tear film. The average of 3 measures.
Time frame: Change from baseline at Day 30
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Day 1 (Baseline) | 4.3 seconds | Standard Deviation 2.1 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Day 7 | 0.9 seconds | Standard Deviation 2.3 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Day 30 | 1.1 seconds | Standard Deviation 2.7 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Day 1 (Baseline) | 4.3 seconds | Standard Deviation 2 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Day 7 | 0.9 seconds | Standard Deviation 2.1 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Day 30 | 0.9 seconds | Standard Deviation 2.4 |
Secondary
Patient Acceptability Score (Dryness) at Day 30
Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).
Time frame: Day 30
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability Score (Dryness) at Day 30 | Day 1 (Baseline) | 47.4 Units on scale | Standard Deviation 22.8 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability Score (Dryness) at Day 30 | Day 7 | 60.7 Units on scale | Standard Deviation 21.1 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability Score (Dryness) at Day 30 | Day 30 | 63.3 Units on scale | Standard Deviation 22.7 |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability Score (Dryness) at Day 30 | Day 1 (Baseline) | 44.6 Units on scale | Standard Deviation 20.5 |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability Score (Dryness) at Day 30 | Day 7 | 57.7 Units on scale | Standard Deviation 22.5 |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability Score (Dryness) at Day 30 | Day 30 | 63.8 Units on scale | Standard Deviation 22.8 |
Secondary
Patient Acceptability Score (Vision) at Day 30
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).
Time frame: Day 30
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability Score (Vision) at Day 30 | Day 1 (Baseline) | 56.8 Units on a scale | Standard Deviation 22.4 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability Score (Vision) at Day 30 | Day 7 | 65.3 Units on a scale | Standard Deviation 17.8 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability Score (Vision) at Day 30 | Day 30 | 65.4 Units on a scale | Standard Deviation 20.1 |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability Score (Vision) at Day 30 | Day 1 (Baseline) | 54.2 Units on a scale | Standard Deviation 21.6 |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability Score (Vision) at Day 30 | Day 7 | 62.6 Units on a scale | Standard Deviation 19.6 |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability Score (Vision) at Day 30 | Day 30 | 66.4 Units on a scale | Standard Deviation 19.4 |
Post Hoc
Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30
Central staining score is based on modified Oxford Scheme measured on a scale of 0-5 (0= no staining, 5= most severe staining)
Time frame: Day 30
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 | Day 1 (Baseline) | 0.7 Units on a scale | Standard Deviation 0.8 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 | Day 7 | 0.5 Units on a scale | Standard Deviation 0.7 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 | Day 30 | 0.4 Units on a scale | Standard Deviation 0.6 |
| Carboxymethylcellulose Based Artificial Tear | Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 | Day 1 (Baseline) | 0.8 Units on a scale | Standard Deviation 0.8 |
| Carboxymethylcellulose Based Artificial Tear | Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 | Day 7 | 0.5 Units on a scale | Standard Deviation 0.7 |
| Carboxymethylcellulose Based Artificial Tear | Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 | Day 30 | 0.4 Units on a scale | Standard Deviation 0.7 |
Post Hoc
Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30
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)
Time frame: Day 30
Population: Intent to Treat Population (Modified)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 | Day 30 | 22.8 Units on a scale | Standard Deviation 20.4 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | 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 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 | Day 7 | 24.8 Units on a scale | Standard Deviation 20 |
| Carboxymethylcellulose Based Artificial Tear | Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 | Day 1 (Baseline) | 41.6 Units on a scale | Standard Deviation 21.6 |
| Carboxymethylcellulose Based Artificial Tear | Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 | Day 7 | 26.9 Units on a scale | Standard Deviation 20.2 |
| Carboxymethylcellulose Based Artificial Tear | Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 | Day 30 | 25.6 Units on a scale | Standard Deviation 22.4 |