Efficacy, tolerability and comfort of a 0.3% hypromellose gel ophthalmic lubricant in the treatment of patients with moderate to severe dry eye syndrome.

OBJECTIVE

To evaluate efficacy, safety and comfort of a 0.3% hypromellose (HM) eye gel (GenTeal Lubricant Eye Gel), with a sodium perborate preservative system and carbomer gelling agent, in patients with dry eye.

RESEARCH DESIGN AND METHODS

Patients with moderate-to-severe dry eye syndrome were enrolled in this open label study and assessed at three visits; a screening consultation (baseline) and two follow-up visits on day 14 (+/- 4 days) and day 28 (+/- 4 days). All screening, evaluation and follow-up visits were carried out at the Tauber Eye Center (formerly the Hunkeler Eye Center), Kansas City. Patients were treated with the product over a 4-week period. They were instructed to use the product at least two times daily, more if necessary, with one drop instilled into the conjunctive sac of both eyes.

MAIN OUTCOME MEASURES

Efficacy was measured by ocular symptoms (burning, stinging, foreign body sensation, dryness, pain/soreness and photophobia), ocular signs (eyelid erythema, bulbar conjunctival injection and corneal superficial punctate keratitis score), tear breakup time and global assessment of ocular comfort. Tolerability measures were change from baseline in best corrected Snellen visual acuity and monitoring of adverse events.

RESULTS

Thirty-seven patients completed this study. The mean sum symptom score at each visit was significantly lower compared with baseline with approximately 30% reduction in the sum symptom score at 2 weeks and approximately 33% at 4 weeks after treatment initiation (p < 0.001). Mean individual symptom scores for dryness, stinging and foreign body sensation decreased by approximately 40% at the end of the study (p < 0.02). Tear breakup time increased from baseline by 53% and 59% at 2 and 4 weeks, respectively (p < 0.001). The proportion of patients reporting a global evaluation of slightly better or much better was approximately 74% at 2 weeks and 78% at 4 weeks after treatment initiation. The product was well tolerated, with one related adverse event reported.

CONCLUSIONS

In a small, open-label study, this 0.3% HM eye gel showed statistically significant effects in relieving ocular symptoms and provides a well-tolerated formula that effectively reduced symptoms and improved ocular comfort in patients with dry eye syndrome.