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

Study Overview
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Brief Summary
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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
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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
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Dry Eye

Intervention / Treatment
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* Drug: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel
* Drug: Hydroxypropyl Guar Galactomannan Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPGG 0.25%<br>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<br> <br> * Other names: HPGG;|
| Placebo Comparator: HPGG Vehicle<br>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<br>* Inactive ingredients used as a placebo comparator<br>* Other names: HPGG Vehicle;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSDI, corneal staining, Dry Eye, Dry Eye Signs and Symptoms in Dry Eye Patients