Clinical trial NCT00840268: A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: OSDI
corneal staining
Dry Eye
Dry Eye Signs and Symptoms in Dry Eye Patients
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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.

Primary outcomes:
measure: Mean change from baseline in sodium fluorescein corneal staining score
timeFrame: Baseline (Day 7), Up to Day 28
Secondary outcomes:
measure: Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score
timeFrame: Baseline (Day 7), Up to Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jay H. Mashburn
role: STUDY_DIRECTOR
References: