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Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial.

Patane MA, Cohen A, From S, Torkildsen G, Welch D, Ousler GW - Clin Ophthalmol (2011)

Bottom Line: The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032).Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups.Most AEs were mild and no severe AEs were observed.

View Article: PubMed Central - PubMed

Affiliation: Eyegate Pharmaceuticals, Inc, 100 Beaver Street, Waltham, MA 02453, USA. mpatane@eyegatepharma.com

ABSTRACT

Purpose: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 mg/mL [DP]) in dry eye patients.

Methods: The study employed a prospective, single-center, double-masked design utilizing a Controlled Adverse Environment (CAE). Patients (n = 103) with confirmed signs and symptoms of dry eye syndrome were randomized into 1 of 3 iontophoresis treatment groups: 7.5 mA-min at 2.5 mA (DP 7.5, n = 41); 10.5 mA-min at 3.5 mA (DP 10.5, n = 37); or 10.5 mA-min at 3.5 mA (placebo, n = 25). Three CAE visits and 4 follow-up visits occurred over 3 weeks. Patients meeting enrollment criteria received iontophoresis in both eyes after the second CAE exposure (visit 3) and before the third CAE exposure (visit 5). Primary efficacy endpoints were corneal staining and ocular discomfort. Secondary endpoints included tear film break-up time, ocular protection index (OPI), and symptomatology.

Results: The DP 7.5 and DP 10.5 treatment groups showed statistically significant improvements in signs and symptoms of dry eye at various time points; however, the primary endpoints were not achieved. The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032). Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups. Most AEs were mild and no severe AEs were observed.

Conclusion: Ocular iontophoresis of EGP-437 demonstrated statistically and clinically significant improvements in signs and symptoms of dry eye syndrome within a CAE model.

No MeSH data available.


Related in: MedlinePlus

Corneal staining is decreased by iontophoretic dexamethasone phosphate. The mean change in corneal fluorescein staining (inferior region) between visit 1 (baseline) to visit 7 for each treatment group. Over this time frame, the DP 7.5 treatment group showed a statistically significant decrease in staining compared with the placebo treatment group.Abbreviation: DP, dexamethasone phosphate.
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f4-opth-5-633: Corneal staining is decreased by iontophoretic dexamethasone phosphate. The mean change in corneal fluorescein staining (inferior region) between visit 1 (baseline) to visit 7 for each treatment group. Over this time frame, the DP 7.5 treatment group showed a statistically significant decrease in staining compared with the placebo treatment group.Abbreviation: DP, dexamethasone phosphate.

Mentions: At visit 7, differences between the DP 7.5 treatment and placebo groups were documented, including the TFBUT as described above and a trend toward improved corneal fluorescein staining (inferior region of the Ora scale in the ITT-LOCF-WE, P = 0.086, two-sample t-test and P = 0.092, Wilcoxon). When comparing endpoints across the entire study’s duration (between visit 1 baseline and visit 7 study exit), a statistically significant decrease in fluorescein staining in the inferior region of the Ora scale was revealed for the DP 7.5 treatment group over placebo (0.51, P = 0.038, Wilcoxon, Figure 4).


Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial.

Patane MA, Cohen A, From S, Torkildsen G, Welch D, Ousler GW - Clin Ophthalmol (2011)

Corneal staining is decreased by iontophoretic dexamethasone phosphate. The mean change in corneal fluorescein staining (inferior region) between visit 1 (baseline) to visit 7 for each treatment group. Over this time frame, the DP 7.5 treatment group showed a statistically significant decrease in staining compared with the placebo treatment group.Abbreviation: DP, dexamethasone phosphate.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3104791&req=5

f4-opth-5-633: Corneal staining is decreased by iontophoretic dexamethasone phosphate. The mean change in corneal fluorescein staining (inferior region) between visit 1 (baseline) to visit 7 for each treatment group. Over this time frame, the DP 7.5 treatment group showed a statistically significant decrease in staining compared with the placebo treatment group.Abbreviation: DP, dexamethasone phosphate.
Mentions: At visit 7, differences between the DP 7.5 treatment and placebo groups were documented, including the TFBUT as described above and a trend toward improved corneal fluorescein staining (inferior region of the Ora scale in the ITT-LOCF-WE, P = 0.086, two-sample t-test and P = 0.092, Wilcoxon). When comparing endpoints across the entire study’s duration (between visit 1 baseline and visit 7 study exit), a statistically significant decrease in fluorescein staining in the inferior region of the Ora scale was revealed for the DP 7.5 treatment group over placebo (0.51, P = 0.038, Wilcoxon, Figure 4).

Bottom Line: The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032).Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups.Most AEs were mild and no severe AEs were observed.

View Article: PubMed Central - PubMed

Affiliation: Eyegate Pharmaceuticals, Inc, 100 Beaver Street, Waltham, MA 02453, USA. mpatane@eyegatepharma.com

ABSTRACT

Purpose: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 mg/mL [DP]) in dry eye patients.

Methods: The study employed a prospective, single-center, double-masked design utilizing a Controlled Adverse Environment (CAE). Patients (n = 103) with confirmed signs and symptoms of dry eye syndrome were randomized into 1 of 3 iontophoresis treatment groups: 7.5 mA-min at 2.5 mA (DP 7.5, n = 41); 10.5 mA-min at 3.5 mA (DP 10.5, n = 37); or 10.5 mA-min at 3.5 mA (placebo, n = 25). Three CAE visits and 4 follow-up visits occurred over 3 weeks. Patients meeting enrollment criteria received iontophoresis in both eyes after the second CAE exposure (visit 3) and before the third CAE exposure (visit 5). Primary efficacy endpoints were corneal staining and ocular discomfort. Secondary endpoints included tear film break-up time, ocular protection index (OPI), and symptomatology.

Results: The DP 7.5 and DP 10.5 treatment groups showed statistically significant improvements in signs and symptoms of dry eye at various time points; however, the primary endpoints were not achieved. The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032). Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups. Most AEs were mild and no severe AEs were observed.

Conclusion: Ocular iontophoresis of EGP-437 demonstrated statistically and clinically significant improvements in signs and symptoms of dry eye syndrome within a CAE model.

No MeSH data available.


Related in: MedlinePlus