Abstract
Purpose: :
Two studies were conducted evaluating the performance of a novel lubricant eye drop. The first study measured lipid layer thickness (LLT) and the second evaluated drop haze (blur), comfort and acceptability.
Methods: :
Declaration of Helsinki was followed. The novel tear is a unique oil-in-water emulsion containing propylene glycol as the active demulcent and POLYQUAD® as the preservative (Alcon). Study 1: 40 patients were enrolled in a randomized, double masked, contralateral eye study. To qualify, patients had to give a positive response to the question "Do you ever feel your eyes?" and show a baseline LLT of ≤ 75nm in both eyes not varying by more than + 15nm over the course of a 10-min observation period. The control was a glycerin/CMC based tear preserved with PURITETM (Allergan). One drop of the assigned test article was administered per eye per randomization. LLT was assessed at 1, 5, 15 and 60 min post drop instillation. Study 2: 20 dry eye patients were enrolled in a double masked, randomized two-period cross over study. After drop instillation a 3-min Haze (blur) profile (30 sec intervals) was measured followed by comfort and acceptability scales. The control contained light mineral oil and mineral oil as the actives with PHMB as the preservative (B&L).
Results: :
Study 1: Significant improvements in LLT favoring the novel lubricant eye drop were seen at all time points after dosing versus the glycerin based control: 1 min (p<0.0001), 5 min (p<0.0001), 15 min (p<0.0001) and 60 min (p=0.0002). Study 2: showed less haze (blur) effect at time 0 (p<0.0001) and 30 sec (p=0.0324). Drop comfort was significantly better for the novel lubricant eye drop (p=0.0070). Drop acceptability was numerically but not significantly better for the novel drop vs the mineral oil control.
Conclusions: :
This novel lubricant eye drop demonstrated significant improvements in LLT up to 60 minutes post instillation as compared to a control and demonstrated less Haze (blur) and better Comfort than a mineral oil based tear.
Clinical Trial: :
www.clinicaltrials.gov NCT00848068/NCT00983203
Keywords: cornea: tears/tear film/dry eye • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cornea: clinical science