Status:
COMPLETED
A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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 chart at Visit 1.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Diagnosis of Sjogren's syndrome (or suspected to have Sjogren's syndrome).
- History or evidence of ocular or intraocular surgery in either eye within the previous year.
- History or evidence of serious ocular trauma in either eye within the previous 6 months.
- History or evidence of corneal transplant or transplant variant procedures.
- History of intolerance or hypersensitivity to any component of the study medications.
- History of glaucoma or current ocular hypertension in either eye, or treatment for either condition within 6 months prior to Visit 1.
- History or evidence of corneal conditions, other than dry eye, that may affect the corneal structure.
- Use of any concomitant topical ocular medications including artificial tears during the study period.
- Females of childbearing potential if breastfeeding, unwilling to undergo urine pregnancy test at screening and upon exiting the study, have a positive urine pregnancy test at screening, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study.
- Use of RESTASIS® 0.05% or an ocular steroid within 30 days of Visit 1.
- Use of systemic medications that have not been stable for 30 days prior to Visit 1.
- Any ocular condition that may preclude the safe administration of the test article.
- Unwilling to discontinue contact lens wear at least 4 weeks prior to Visit 1, and during the study period.
- Use of punctal plugs or punctal cautery.
- Use of lid scrubs/warm compresses within 14 days of Visit 1.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT00840268
Start Date
February 1 2009
End Date
July 1 2009
Last Update
July 17 2014
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