Dry Eye
Conditions
Brief summary
To evaluate the safety and efficacy of two artificial tears in dry eye patients.
Interventions
OTHERSYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
OTHEROptive
Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of dry eyes * Must not have worn contact lenses for 1 week preceding enrollment
Exclusion criteria
* Age related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break-up Time | Day 0, Day 7, Day 14, Day 28, and Day 42 | Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp. |
| Conjunctival Staining | Day 0, Day 7, Day 14, Day 28, Day 42 | Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining. |
| Corneal Staining | Day 0, Day 7, Day 14, Day 28, Day 42 | Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining. |
Countries
United States
Participant flow
Recruitment details
109 dry eye subjects
Pre-assignment details
Randomized, double-masked, parallel design
Participants by arm
| Arm | Count |
|---|---|
| SYSTANE Ultra SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days | 53 |
| OPTIVE Lubricant Eye Drops OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days | 56 |
| Total | 109 |
Baseline characteristics
| Characteristic | SYSTANE Ultra | OPTIVE Lubricant Eye Drops | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 13 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 43 Participants | 77 Participants |
| Sex: Female, Male Female | 39 Participants | 41 Participants | 80 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 53 | 0 / 56 |
| serious Total, serious adverse events | 0 / 53 | 0 / 56 |
Outcome results
Primary
Conjunctival Staining
Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Time frame: Day 0, Day 7, Day 14, Day 28, Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE Ultra | Conjunctival Staining | Day 7 | 2.1 Units on a scale | Standard Deviation 1.1 |
| SYSTANE Ultra | Conjunctival Staining | Day 28 | 1.9 Units on a scale | Standard Deviation 1.1 |
| SYSTANE Ultra | Conjunctival Staining | Day 14 | 2.0 Units on a scale | Standard Deviation 1.2 |
| SYSTANE Ultra | Conjunctival Staining | Day 42 | 1.9 Units on a scale | Standard Deviation 1 |
| SYSTANE Ultra | Conjunctival Staining | Day 0 | 2.3 Units on a scale | Standard Deviation 1.1 |
| OPTIVE Lubricant Eye Drops | Conjunctival Staining | Day 42 | 2.7 Units on a scale | Standard Deviation 1.4 |
| OPTIVE Lubricant Eye Drops | Conjunctival Staining | Day 0 | 2.8 Units on a scale | Standard Deviation 1.4 |
| OPTIVE Lubricant Eye Drops | Conjunctival Staining | Day 7 | 2.5 Units on a scale | Standard Deviation 1.3 |
| OPTIVE Lubricant Eye Drops | Conjunctival Staining | Day 14 | 2.2 Units on a scale | Standard Deviation 1.4 |
| OPTIVE Lubricant Eye Drops | Conjunctival Staining | Day 28 | 2.4 Units on a scale | Standard Deviation 1.5 |
Primary
Corneal Staining
Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.
Time frame: Day 0, Day 7, Day 14, Day 28, Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE Ultra | Corneal Staining | Day 7 | 3.6 Units on a scale | Standard Deviation 2.2 |
| SYSTANE Ultra | Corneal Staining | Day 28 | 3.1 Units on a scale | Standard Deviation 2.1 |
| SYSTANE Ultra | Corneal Staining | Day 14 | 2.9 Units on a scale | Standard Deviation 2.1 |
| SYSTANE Ultra | Corneal Staining | Day 42 | 2.9 Units on a scale | Standard Deviation 1.8 |
| SYSTANE Ultra | Corneal Staining | Day 0 | 4.8 Units on a scale | Standard Deviation 1.8 |
| OPTIVE Lubricant Eye Drops | Corneal Staining | Day 42 | 4.2 Units on a scale | Standard Deviation 2.8 |
| OPTIVE Lubricant Eye Drops | Corneal Staining | Day 0 | 5.3 Units on a scale | Standard Deviation 2.5 |
| OPTIVE Lubricant Eye Drops | Corneal Staining | Day 7 | 4.3 Units on a scale | Standard Deviation 3 |
| OPTIVE Lubricant Eye Drops | Corneal Staining | Day 14 | 4.5 Units on a scale | Standard Deviation 2.9 |
| OPTIVE Lubricant Eye Drops | Corneal Staining | Day 28 | 3.8 Units on a scale | Standard Deviation 2.6 |
Primary
Tear Break-up Time
Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Time frame: Day 0, Day 7, Day 14, Day 28, and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE Ultra | Tear Break-up Time | Day 7 | 4.7 seconds | Standard Deviation 2.8 |
| SYSTANE Ultra | Tear Break-up Time | Day 28 | 4.6 seconds | Standard Deviation 2.6 |
| SYSTANE Ultra | Tear Break-up Time | Day 14 | 4.8 seconds | Standard Deviation 2.8 |
| SYSTANE Ultra | Tear Break-up Time | Day 42 | 4.5 seconds | Standard Deviation 2.3 |
| SYSTANE Ultra | Tear Break-up Time | Day 0 | 4.2 seconds | Standard Deviation 1.9 |
| OPTIVE Lubricant Eye Drops | Tear Break-up Time | Day 42 | 4.2 seconds | Standard Deviation 2.3 |
| OPTIVE Lubricant Eye Drops | Tear Break-up Time | Day 0 | 4.5 seconds | Standard Deviation 2.3 |
| OPTIVE Lubricant Eye Drops | Tear Break-up Time | Day 7 | 4.2 seconds | Standard Deviation 1.8 |
| OPTIVE Lubricant Eye Drops | Tear Break-up Time | Day 14 | 4.2 seconds | Standard Deviation 1.8 |
| OPTIVE Lubricant Eye Drops | Tear Break-up Time | Day 28 | 5.2 seconds | Standard Deviation 3.2 |