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The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) ophthalmic gel compared to Vehicle for the treatment of dry eye.
A 7-day Vehicle pre-randomization (run-in) phase during which all patients will receive 1 drop of Vehicle in each eye twice daily will precede the 21-day treatment phase, for an overall study duration of 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPGG 0.25% | Experimental | Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase). |
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| HPGG Vehicle | Placebo Comparator | Hydroxypropyl Guar Galactomannan Vehicle, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in sodium fluorescein corneal staining score | Baseline (Day 7), Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score | Baseline (Day 7), Up to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay H. Mashburn | Alcon Research | Study Director |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Hydroxypropyl Guar Galactomannan Vehicle |
| Drug |
Inactive ingredients used as a placebo comparator |
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