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

NCT ID: NCT00840268

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 427 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-07-31

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 of 28 days.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HPGG 0.25%

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).

Group Type: EXPERIMENTAL

Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel

Intervention Type: DRUG

HPGG Vehicle

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).

Group Type: PLACEBO_COMPARATOR

Hydroxypropyl Guar Galactomannan Vehicle

Intervention Type: DRUG

Inactive ingredients used as a placebo comparator

Interventions

Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel

Intervention Type: DRUG

Hydroxypropyl Guar Galactomannan Vehicle

Inactive ingredients used as a placebo comparator

Intervention Type: DRUG

Other Intervention Names

HPGG; HPGG Vehicle

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay H. Mashburn

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-08-34

Identifier Type: -

Identifier Source: org_study_id