An interventional study of Propylene Glycol 0.6% eye drops in Dry Eye, sponsored by Alcon Research. Terminated. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
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.
This study was conducted in India.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
Other: Propylene Glycol 0.6% eye drops
Also known as: Systane® Balance
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
Participants were enrolled from 4 study sites located in India.
| Milestone | Systane Balance |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
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).
| units on a scale | Systane Balance |
|---|---|
| Change from baseline at Day 45 | -3.1 (-8 to 1) |
| Change from baseline at Day 90 | -4.8 (-11 to -1) |
Collected over Adverse events were collected for the duration of participation, an average of 90 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Systane Balance | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Systane Balance |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Systane Balance |
|---|---|
| Female | 8 |
| Male | 6 |
No study locations are listed for this record.
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Alcon Research