Dry Eye
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.
Interventions
OTHERPolyethylene Glycol, 0.4%, Propylene Glycol, 0.3% 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
* Must give informed consent, and be willing and able to attend all study visits. * Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method). * 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, test positive on a pregnancy test, or breast-feeding. * Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study. * Any contraindications or hypersensitivities to the study medications or their components. * Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) 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. * Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening. * Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study. * Participation in any other clinical trial within 30 days prior to Screening. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corneal Staining at All Study Time Points | Baseline (Day 0), Day 45, Day 90 | Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface. |
Countries
India
Participant flow
Recruitment details
Subjects were recruited from 13 study centers in India.
Pre-assignment details
Of the 207 enrolled, 6 subjects were exited as screen failures prior to treatment. In addition, 1 subject met the entry criteria, but discontinued prior to the first instillation of investigational product (IP). This reporting group includes all treated subjects (200).
Participants by arm
| Arm | Count |
|---|---|
| Systane Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Systane |
|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 13.43 |
| Corneal Staining | 5.7 units on a scale STANDARD_DEVIATION 2.12 |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 207 | 0 / 200 |
| other Total, other adverse events | 0 / 207 | 0 / 200 |
| serious Total, serious adverse events | 0 / 207 | 0 / 200 |
Outcome results
Primary
Change From Baseline in Corneal Staining at All Study Time Points
Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.
Time frame: Baseline (Day 0), Day 45, Day 90
Population: Full Analysis Set. Number analyzed includes number of subjects with non-missing response in specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane | Change From Baseline in Corneal Staining at All Study Time Points | Change from baseline at Day 45 | -2.7 units on a scale | Standard Error 0.14 |
| Systane | Change From Baseline in Corneal Staining at All Study Time Points | Change from baseline at Day 90 | -4.0 units on a scale | Standard Error 0.16 |