Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00840268 | A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients | PHASE2 | COMPLETED | 427 | — | — | Feb 1, 2009 | Jul 1, 2009 | Jul 17, 2014 | - | — |
| Arm | Type | Description |
|---|---|---|
| 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). |
| 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). |
| Name | Type | Description |
|---|---|---|
| Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel | DRUG | - |
| Hydroxypropyl Guar Galactomannan Vehicle | DRUG | Inactive ingredients used as a placebo comparator |
Inclusion Criteria: * Must read, sign, and date an informed consent document and HIPAA privacy document. * Diagnosis of dry eye at Visit 1 (Day 0). * Able and willing to follow study instructions. * Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS c...