A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research

Criteria

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 chart at Visit 1.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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.