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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

Mean ocular discomfort scores during CAE exposure at visit 5. The plot depicts the mean discomfort scores for the placebo and DP 7.5 treatment groups during the course of the visit 5 CAE session. The DP 10.5 group, which was not significantly different from placebo, is omitted for clarity. Data included in the mean value calculation were from the PP-WE population of each group. The DP 7.5 group mean values are significantly lower (P < 0.05) than placebo for all times >60 minutes. Error bars represent standard error of the mean.Abbreviations: CAE, Controlled Adverse Environment; DP, dexamethasone phosphate; PP-WE, per protocol-worst eye.
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f5-opth-5-633: Mean ocular discomfort scores during CAE exposure at visit 5. The plot depicts the mean discomfort scores for the placebo and DP 7.5 treatment groups during the course of the visit 5 CAE session. The DP 10.5 group, which was not significantly different from placebo, is omitted for clarity. Data included in the mean value calculation were from the PP-WE population of each group. The DP 7.5 group mean values are significantly lower (P < 0.05) than placebo for all times >60 minutes. Error bars represent standard error of the mean.Abbreviations: CAE, Controlled Adverse Environment; DP, dexamethasone phosphate; PP-WE, per protocol-worst eye.

Mentions: The differences in mean ocular discomfort scores between both DP groups and placebo during CAE exposure at visit 5, the primary endpoint for symptoms, were not statistically significant; however, the differences in the mean ocular discomfort scores for DP 7.5 versus placebo at several discrete time points during the visit 5 CAE exposure were statistically significant (PP-WE, Figure 5). In order to determine if the patients reporting lower ocular discomfort scores during the visit 5 CAE experienced improvements in any relevant dry eye signs, two subgroups of patients were evaluated: those demonstrating ocular discomfort scores of <3 and those demonstrating ocular discomfort scores <4 at all time points between 50 and 90 minutes during visit 5 CAE exposure. For patients in the subgroup scoring <4 at all time points between 50 and 90 minutes during visit 5 CAE exposure, the visit 6 and 7 data demonstrated significantly longer mean TFBUTs for both active treatment groups compared with the placebo group (Table 3).


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)

Mean ocular discomfort scores during CAE exposure at visit 5. The plot depicts the mean discomfort scores for the placebo and DP 7.5 treatment groups during the course of the visit 5 CAE session. The DP 10.5 group, which was not significantly different from placebo, is omitted for clarity. Data included in the mean value calculation were from the PP-WE population of each group. The DP 7.5 group mean values are significantly lower (P < 0.05) than placebo for all times >60 minutes. Error bars represent standard error of the mean.Abbreviations: CAE, Controlled Adverse Environment; DP, dexamethasone phosphate; PP-WE, per protocol-worst eye.
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Related In: Results  -  Collection

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getmorefigures.php?uid=PMC3104791&req=5

f5-opth-5-633: Mean ocular discomfort scores during CAE exposure at visit 5. The plot depicts the mean discomfort scores for the placebo and DP 7.5 treatment groups during the course of the visit 5 CAE session. The DP 10.5 group, which was not significantly different from placebo, is omitted for clarity. Data included in the mean value calculation were from the PP-WE population of each group. The DP 7.5 group mean values are significantly lower (P < 0.05) than placebo for all times >60 minutes. Error bars represent standard error of the mean.Abbreviations: CAE, Controlled Adverse Environment; DP, dexamethasone phosphate; PP-WE, per protocol-worst eye.
Mentions: The differences in mean ocular discomfort scores between both DP groups and placebo during CAE exposure at visit 5, the primary endpoint for symptoms, were not statistically significant; however, the differences in the mean ocular discomfort scores for DP 7.5 versus placebo at several discrete time points during the visit 5 CAE exposure were statistically significant (PP-WE, Figure 5). In order to determine if the patients reporting lower ocular discomfort scores during the visit 5 CAE experienced improvements in any relevant dry eye signs, two subgroups of patients were evaluated: those demonstrating ocular discomfort scores of <3 and those demonstrating ocular discomfort scores <4 at all time points between 50 and 90 minutes during visit 5 CAE exposure. For patients in the subgroup scoring <4 at all time points between 50 and 90 minutes during visit 5 CAE exposure, the visit 6 and 7 data demonstrated significantly longer mean TFBUTs for both active treatment groups compared with the placebo group (Table 3).

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