Clinical evaluation of an HP-guar gellable lubricant eye drop for the relief of dryness of the eye.
OBJECTIVE
To evaluate the efficacy of a new lubricant eye drop containing polyethylene glycol 400 and propylene glycol demulcents with hydroxypropyl-guar as a gelling agent (Test Product) to a system with carboxymethylcellulose (Control Product) for reducing dry eye signs and symptoms.


METHODS
Eighty-seven dry eye volunteers were enrolled at seven sites for this six-week, concurrently controlled, double-masked clinical study.


RESULTS
The Test Product significantly reduced conjunctival staining (p = 0.025) and temporal corneal staining (p = 0.024) compared to the Control. The Test Product also significantly reduced symptoms of dryness in the morning and evening, compared to the Control (p = 0.015 and p = 0.023, respectively). Subjects in the Test treatment group reported lower frequencies of foreign body sensation and felt their eyes were "refreshed longer" compared to those in the Control group (p = 0.033 and p = 0.037, respectively).


CONCLUSIONS
The Test Product was more effective at reducing both the signs and symptoms of dry eye compared to the carboxymethylcellulose containing Control.
Christensen
Mike T
MT
Alcon Labs, Consumer Products, Fort Worth, TX, USA. mike.christensen@alconlabs.com
Cohen
Steven
S
Rinehart
John
J
Akers
Frank
F
Pemberton
Bart
B
Bloomenstein
Marc
M
Lesher
Mark
M
Kaplan
David
D
Meadows
David
D
Meuse
Patricia
P
Hearn
Charles
C
Stein
Jerry M
JM
D002266:Carboxymethylcellulose Sodium / Q000008:administration & dosage; D003228:Conjunctiva / Q000187:drug effects / Q000473:pathology; D003315:Cornea / Q000187:drug effects / Q000473:pathology; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D015352:Dry Eye Syndromes / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005685:Galactans; D005782:Gels; D006801:Humans; D008153:Lubrication; D008297:Male; D008351:Mannans; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage*; D053149:Plant Gums; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011310:Preservatives, Pharmaceutical; D019946:Propylene Glycol / Q000008:administration & dosage*; D012449:Safety; D016896:Treatment Outcome
D005685:Galactans; D005782:Gels; D008351:Mannans; D009883:Ophthalmic Solutions; D053149:Plant Gums; D011310:Preservatives, Pharmaceutical; D011092:Polyethylene Glycols; D019946:Propylene Glycol; C007894:guar gum; D002266:Carboxymethylcellulose Sodium