Dry Eye Syndromes
Conditions
Brief summary
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
Interventions
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
DRUGCarboxymethylcellulose Based Eye Drop Formulation B
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
DRUGCarboxymethylcellulose Based Lubricant Eye Drops
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dry eyes * Current use of eye drops for dry eye at least twice daily, on average for at least 3 months
Exclusion criteria
* Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months * Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months * Active ocular allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Baseline, Day 30 | The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tear Break-up Time | Baseline, Day 30 | Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement. |
| Change From Baseline in Corneal Staining | Baseline, Day 30 | 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 a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement). |
| Change From Baseline in Conjunctival Staining | Baseline, Day 30 | 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. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement). |
| Change From Baseline in Schirmer Test Results | Baseline, Day 30 | The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | 105 |
| Carboxymethylcellulose Based Eye Drop Formulation B Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. | 51 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. | 103 |
| Carboxymethylcellulose Based Lubricant Eye Drops Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | 56 |
| Total | 315 |
Baseline characteristics
| Characteristic | Total | Carboxymethylcellulose Based Eye Drop Formulation A | Carboxymethylcellulose Based Eye Drop Formulation B | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Carboxymethylcellulose Based Lubricant Eye Drops |
|---|---|---|---|---|---|
| Age, Customized 30 to 40 years | 28 Participants | 10 Participants | 3 Participants | 12 Participants | 3 Participants |
| Age, Customized <30 years | 25 Participants | 9 Participants | 5 Participants | 6 Participants | 5 Participants |
| Age, Customized >40 years | 262 Participants | 86 Participants | 43 Participants | 85 Participants | 48 Participants |
| Sex: Female, Male Female | 255 Participants | 83 Participants | 44 Participants | 87 Participants | 41 Participants |
| Sex: Female, Male Male | 60 Participants | 22 Participants | 7 Participants | 16 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 105 | 0 / 51 | 0 / 103 | 0 / 56 |
| serious Total, serious adverse events | 1 / 105 | 0 / 51 | 0 / 103 | 1 / 56 |
Outcome results
Primary
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Baseline | 41.48 Score on a scale | Standard Deviation 14.797 |
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Change from baseline at Day 30 | -15.66 Score on a scale | Standard Deviation 14.717 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Change from baseline at Day 30 | -9.78 Score on a scale | Standard Deviation 17.986 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Baseline | 38.27 Score on a scale | Standard Deviation 12.825 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Baseline | 40.28 Score on a scale | Standard Deviation 13.509 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Change from baseline at Day 30 | -14.59 Score on a scale | Standard Deviation 15.09 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Baseline | 40.18 Score on a scale | Standard Deviation 13.443 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Ocular Surface Disease Index© Questionnaire Score | Change from baseline at Day 30 | -13.77 Score on a scale | Standard Deviation 16.112 |
Secondary
Change From Baseline in Conjunctival Staining
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. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Conjunctival Staining | Baseline | 6.7 Score on as scale | Standard Deviation 5.69 |
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Conjunctival Staining | Change from baseline at Day 30 | -0.6 Score on as scale | Standard Deviation 4.17 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Conjunctival Staining | Change from baseline at Day 30 | 0.5 Score on as scale | Standard Deviation 3.77 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Conjunctival Staining | Baseline | 6.3 Score on as scale | Standard Deviation 4.77 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Conjunctival Staining | Baseline | 6.1 Score on as scale | Standard Deviation 4.41 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Conjunctival Staining | Change from baseline at Day 30 | -1.2 Score on as scale | Standard Deviation 3.7 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Conjunctival Staining | Baseline | 6.7 Score on as scale | Standard Deviation 5.37 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Conjunctival Staining | Change from baseline at Day 30 | -0.8 Score on as scale | Standard Deviation 3.7 |
Secondary
Change From Baseline in Corneal Staining
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 a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Corneal Staining | Baseline | 4.9 Score on a scale | Standard Deviation 3.84 |
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Corneal Staining | Change from baseline at Day 30 | -0.7 Score on a scale | Standard Deviation 2.9 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Corneal Staining | Change from baseline at Day 30 | 0.1 Score on a scale | Standard Deviation 3.17 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Corneal Staining | Baseline | 5.0 Score on a scale | Standard Deviation 3.76 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Corneal Staining | Baseline | 5.0 Score on a scale | Standard Deviation 3.92 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Corneal Staining | Change from baseline at Day 30 | -1.5 Score on a scale | Standard Deviation 2.37 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Corneal Staining | Baseline | 4.7 Score on a scale | Standard Deviation 3.24 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Corneal Staining | Change from baseline at Day 30 | -1.4 Score on a scale | Standard Deviation 2.89 |
Secondary
Change From Baseline in Schirmer Test Results
The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Schirmer Test Results | Baseline | 10.3 millimeters | Standard Deviation 7.37 |
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Schirmer Test Results | Change from baseline at Day 30 | 1.8 millimeters | Standard Deviation 6.97 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Schirmer Test Results | Change from baseline at Day 30 | 2.4 millimeters | Standard Deviation 6.3 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Schirmer Test Results | Baseline | 8.4 millimeters | Standard Deviation 7.26 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Schirmer Test Results | Baseline | 10.4 millimeters | Standard Deviation 6.79 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Schirmer Test Results | Change from baseline at Day 30 | 2.0 millimeters | Standard Deviation 6.27 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Schirmer Test Results | Baseline | 10.1 millimeters | Standard Deviation 7.6 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Schirmer Test Results | Change from baseline at Day 30 | 2.6 millimeters | Standard Deviation 6.59 |
Secondary
Change From Baseline in Tear Break-up Time
Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Tear Break-up Time | Baseline | 4.92 Seconds | Standard Deviation 1.79 |
| Carboxymethylcellulose Based Eye Drop Formulation A | Change From Baseline in Tear Break-up Time | Change from baseline at Day 30 | 1.36 Seconds | Standard Deviation 2.848 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Tear Break-up Time | Change from baseline at Day 30 | 1.21 Seconds | Standard Deviation 2.521 |
| Carboxymethylcellulose Based Eye Drop Formulation B | Change From Baseline in Tear Break-up Time | Baseline | 4.61 Seconds | Standard Deviation 1.739 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Tear Break-up Time | Baseline | 4.94 Seconds | Standard Deviation 1.808 |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Change From Baseline in Tear Break-up Time | Change from baseline at Day 30 | 1.33 Seconds | Standard Deviation 2.497 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Tear Break-up Time | Baseline | 5.06 Seconds | Standard Deviation 1.699 |
| Carboxymethylcellulose Based Lubricant Eye Drops | Change From Baseline in Tear Break-up Time | Change from baseline at Day 30 | 1.06 Seconds | Standard Deviation 2.018 |