Dry Eye
Conditions
Keywords
OSDI, corneal staining, Dry Eye, Dry Eye Signs and Symptoms in Dry Eye Patients
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.
Interventions
DRUGHydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel
DRUGHydroxypropyl Guar Galactomannan Vehicle
Inactive ingredients used as a placebo comparator
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in sodium fluorescein corneal staining score | Baseline (Day 7), Up to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score | Baseline (Day 7), Up to Day 28 |
Outcome results
None listed