Dry Eye
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.
Detailed description
This study was conducted in India.
Interventions
OTHERPropylene Glycol 0.6% eye drops
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Sign informed consent and willing and able to attend all study visits; * Dry eye in both eyes diagnosed by an ophthalmologist; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Women of childbearing potential who are pregnant or breastfeeding; * Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study; * Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening; * Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening; * Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening; * Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corneal Staining Total Score | Baseline (Day 0), Day 45, Day 90 | The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15). |
Participant flow
Recruitment details
Participants were enrolled from 4 study sites located in India.
Participants by arm
| Arm | Count |
|---|---|
| Systane Balance Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Systane Balance |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Change From Baseline in Corneal Staining Total Score
The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).
Time frame: Baseline (Day 0), Day 45, Day 90
Population: Analysis includes all participants with data present. Analysis was based on the eye with the higher corneal staining total score at screening or the right eye when both eyes have same corneal staining total score at screening, as observed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Systane Balance | Change From Baseline in Corneal Staining Total Score | Change from baseline at Day 45 | -3.1 units on a scale |
| Systane Balance | Change From Baseline in Corneal Staining Total Score | Change from baseline at Day 90 | -4.8 units on a scale |