Comparison of eye drop retention time using fluorophotometry in three commercially available lubricant eye drops.

SIGNIFICANCE: This is the first study to evaluate the retention time of lubricating eye drops containing various concentrations of sodium hyaluronate using fluorophotometry in a symptomatic dry eye population. Information regarding eye drop retention may be useful for eye care practitioners to assist in the selection of more effective treatments for managing dry eye. PURPOSE: This study aimed to use fluorophotometry to compare retention time on the ocular surface of three commercially available lubricating eye drops, each containing varying concentrations of sodium hyaluronic acid (HA), and their effects on tear film stability post-instillation in a population with symptoms of dry eye. METHODS: Adults with symptoms of dry eye (Ocular Surface Disease Index score, >12) were enrolled in this prospective, double-masked comparison of eye drops containing 0.15% HA-hydroxypropyl guar (HPGuar), 0.2% HA, and 0.1% HA. Participants were randomized to the eye drop order and the study eye under evaluation. Each eye drop was admixed with a fluorescent tracer (70-kDa fluorescein isothiocyanate-dextran) at 10% wt/vol, and 10 µL volume was instilled for each evaluation. A fluorophotometer was used to measure the time for the tracer signal to return to baseline. Fluorescein tear breakup time was measured following fluorophotometry assessment. RESULTS: Retention time for 0.15% HA-HPGuar and 0.2% HA was significantly longer compared with 0.1% HA (p=0.02 and p=0.03). Fluorescein tear breakup time was significantly longer for the 0.15% HA-HPGuar eye drop compared with both the 0.1% HA eye drop (p=0.01) and 0.2% HA eye drop (p=0.003). CONCLUSIONS: Retention time on the ocular surface of the two eye drops containing higher concentrations of HA was longer than the eye drop with the lowest concentration of HA. The tear film was also more stable with the 0.15% HA-HPGuar eye drop compared with the eye drops containing HA alone, which may be attributable to the other components in the 0.15% HA-HPGuar eye drop.

Changes in corneal epithelial irregularity following treatment with artificial tears.

SIGNIFICANCE: Dry eye sufferers have a highly irregular corneal epithelial surface compared with those without dry eye. This study demonstrated that corneal epithelial thickness irregularity can be significantly reduced after as little as 48 hours following treatment with regular use of topical ocular lubricants. PURPOSE: This study aimed to compare changes in corneal epithelial thickness irregularity factor (EIF) and ocular symptoms in a population with symptoms of dry eye before and up to 4 weeks after treatment with two commercially available lubricating eye drops versus saline. METHODS: We conducted a prospective single-center, investigator-masked, randomized, parallel-group dispensing study. Participants with moderate to severe symptoms of dry eye (Ocular Surface Disease Index score >23 at baseline) were enrolled and randomly assigned to receive either 0.15% hyaluronic acid + hydroxypropyl guar, 0.2% hyaluronic acid, or saline (16 in each group). Corneal epithelial thickness measurements were obtained along vertical and horizontal CASIA SS-1000 Optical Coherence Tomography scans at baseline and after 48 hours, 2 weeks, and 4 weeks. The Ocular Surface Disease Index questionnaire was administered at baseline, 2 weeks, and 4 weeks. RESULTS: Forty-eight participants (male-to-female ratio, 17:31) completed the study. Horizontal EIF was significantly lower at all follow-up visits compared with baseline (p=0.001), but there were no significant differences between study eye drops (p=0.34). No significant difference in vertical EIF was observed over time (p=0.32) or between eye drops (p=0.08). Ocular symptoms significantly improved after 2 and 4 weeks of treatment compared with baseline (p<0.001), but no differences were observed between eye drops (p=0.46). CONCLUSIONS: All treatments were effective for reducing EIF along the horizontal meridian 48 hours after initiation of treatment, and improvements were maintained for 4 weeks. Improvements in ocular symptoms were observed with all study treatments.

Comparison of vision performance of spectacles prescribed to 0.05D versus 0.25D steps.

CLINICAL RELEVANCE: Traditionally, refraction is performed, and spectacles are manufactured in in 0.25D-steps. Trial and spectacle lenses manufactured in smaller increments may allow for a more accurate refraction and prescribed spectacles. BACKGROUND: To determine whether refraction in 0.05D-steps improves the proportion of eyes achieving achieve duochrome equality, and whether spectacles prescribed in 0.05D-steps offer any vision benefits, compared to 0.25D-steps. METHODS: Myopic young adults were enrolled into two prospective studies conducted at different sites. Study 1 comprised 66 participants (refracted under cycloplegia) while Study 2 comprised 51 participants (not cyclopleged). A standard refraction was performed in both studies and a trial frame and trial lenses were used to determine the spherical endpoint of duochrome equality (0.25D-steps first then 0.05D-steps). In Study 2, the cylindrical component was refined in 0.05D-steps before the spherical endpoint in 0.05D-steps. Monocular high-contrast-visual-acuity (HCVA) was measured while wearing the final refractions. Participants in Study 2 wore spectacles manufactured in 0.25D and 0.05D-steps for 7 days each in a randomized, double-masked study. Both spectacles appeared identical. Outcome measures assessed on dispensing and after 7 days of wear comprised monocular acuity-based measurements (HCVA, low-contrast-visual-acuity, vanishing-optotype-acuity, contrast-sensitivity) and subjective ratings. The Quality-of-Vision questionnaire and subjective preference were assessed after 7 days. RESULTS: Both studies showed a higher proportion of eyes achieved duochrome equality (P < 0.001) and better average monocular HCVA (P ≤ 0.006) in 0.05D-steps. Study 2 showed 0.05D-step spectacles provided better average results for all monocular acuity-based measurements (P < 0.006) and were preferred by 65% (P = 0.04) of participants after 7 days (P = 0.04). There were no differences between spectacles for any other measures (P > 0.1). CONCLUSIONS: Refraction performed, and spectacles manufactured in 0.05D-steps for this study improved average acuity-based outcomes and were preferred by most participants to spectacles in traditional 0.25D-steps.

The effect of hydroxypropyl-guar nanoemulsion on signs and symptoms of dry eye.

PURPOSE: To examine the effect of hydroxypropyl-guar nanoemulsion (HP-Guar nanoemulsion, Alcon Laboratories Ltd, Fort Worth, TX, USA) versus saline (0.9% sodium chloride; Pfizer Inc., Bentley WA Australia) on the comfort and tear film properties of people with dry eye disease both in the short-term (up to 2 h post-drop instillation) and longer-term (after 4 weeks of 4-times daily use), and to examine the effect on tear inflammatory markers after 4 weeks. METHODS: This was a prospective, investigator-masked, randomised, cross-over dispensing study. Twenty participants with dry eye disease (5 males: 15 females) with average age 46.9 ± 14.4 (range 26 to 70) years were randomized to either HP-Guar nanoemulsion, or saline eye drops. Ocular symptoms, lipid layer thickness, tear evaporation, tear osmolarity and non-invasive break-up time were measured pre-drop instillation, 1 h and 2 h post-eye drop instillation, and after 4-weeks of 4-times daily drop use. Tear inflammatory mediators were measured pre-drop instillation and after 4-weeks. After 4-weeks, patients had a 4-week washout period and then crossed over to the alternate drop. RESULTS: With HP-Guar nanoemulsion, participants reported less grittiness/burning/stinging 1 h post eye drop instillation compared to baseline (79.5 ± 23.3 vs. 66.8 ± 27.7, p = 0.02); less dryness 1 h and 2 h post eye drop instillation compared to baseline (77.8 ± 23.0 and 76.2 ± 23.7 vs. 61.0 ± 27.1 respectively, p < 0.01 for both); and greater overall satisfaction 1 h post drop instillation and after 4 weeks of daily use compared to baseline (80.4 ± 21.6 and 83.4 ± 16.6 vs. 68.6 ± 26.0 respectively, p ≤ 0.011 for both). With saline, participants reported less dryness after 4 weeks of daily use compared to baseline (74.2 ± 23.8 vs. 60.2 ± 24.0, p < 0.01). For HP-Guar nanoemulsion, average lipid layer thickness was significantly thicker 2 h post drop-instillation (79.5 ± 21.7 nm) compared to baseline (63.7 ± 18.9 nm) and the 4-week assessment (62.4 ± 23.1 nm, p < 0.01 for both). For saline, average lipid layer thickness was significantly thicker at 1 h and 2 h post eye drop instillation (76.0 ± 23.8 nm and 80.4 ± 24.8 nm) compared to baseline (61.0 ± 15.6 nm, p < 0.01 for both). There was no difference in inflammatory mediators or other tear variables between drops or visits. CONCLUSION: HP-Guar nanoemulsion was more effective for improving a range of subjective dry eye symptoms both in the short and long-term compared to saline. Both HP-Guar nanoemulsion and saline transiently increased lipid layer thickness.

Effect of a formulated eye drop with Leptospermum spp honey on tear film properties.

AIM: To evaluate the effects of a proprietary formulated eye drop with Leptospermum spp honey versus a conventional lubricant eye drop on tear film properties in subjects with symptoms related to dry eye disease after 28 days of treatment. METHODS: Forty-six subjects with symptoms related to dry eye (Ocular Surface Disease Index (OSDI) score >12) were enrolled and randomly assigned to receive either the test formulated eye drop (Optimel by Melcare Biomedical Pty Ltd) or control eye drops (Alcon, USA) in this double-masked study. Inferior lipid layer thickness (LLT), tear film evaporation rate (TER), fluorescein tear film break-up time (TBUT), corneal staining and subjective symptoms (OSDI and visual analogue scales (VAS)) were measured before and after 28 days of instilling the eye drops. RESULTS: Forty-two subjects completed the study (21 subjects in each group). After 28 days of treatment, TER showed a significantly greater reduction with the formulated eye drop compared with the control (p=0.01). TBUT showed a slight but not statistically significant increase with the formulated eye drop compared with the control (p=0.06), and a significantly greater reduction (improvement) in OSDI scores was observed with the formulated eye drop compared with the control (p=0.01). No significant differences were found between the two groups for inferior LLT, corneal staining and any of the VAS scores. CONCLUSIONS: The formulated eye drops were effective in reducing tear film evaporation rate and were more effective for improving symptoms of dry eye compared with the control eye drops after 28 days of treatment. TRIAL REGISTRATION NUMBER: NCT03622619.