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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel; Drug: Hydroxypropyl Guar Galactomannan Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 427
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel; Other Names: HPGG
Placebo Comparator: 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).	Drug: Hydroxypropyl Guar Galactomannan Vehicle; Inactive ingredients used as a placebo comparator; Other Names: HPGG Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in sodium fluorescein corneal staining score	Baseline (Day 7), Up to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score	Baseline (Day 7), Up to Day 28

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Jay H. Mashburn, Alcon Research

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (Estimate): February 10, 2009

Study Record Updates

• Last Update Posted (Estimate): July 17, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Dry Eye; corneal staining; OSDI; Dry Eye Signs and Symptoms in Dry Eye Patients
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: C-08-34