Limits...
Hydrocortisone concentration influences time to clinically significant healing of acute inflammation of the ocular surface and adnexa - results from a double-blind randomized controlled trial.

Sergiyenko N, Sukhina L, Bezdetko P, Kovalenko Y, Nikitin N, Merzbacher M, Gross D, Kohnen R - BMC Ophthalmol (2014)

Bottom Line: The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations, such as drug concentration.The aim of this study was to confirm that hydrocortisone acetate (HC-ac) ophthalmic ointments of 2.5% and 1% are more effective than a 0.5% eye ointment.In this randomized, double-blind, placebo-controlled, parallel-group clinical study, the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 subjects.Hydrocortisone acetate 2.5% and Hydrocortisone acetate 1% eye ointments are efficacious and safe treatments for acute inflammations of the ocular surface or adnexa, and showed significantly better efficacy than a control group treated with Hydrocortisone acetate 0.5% therapy.

View Article: PubMed Central - HTML - PubMed

Affiliation: URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany. d.gross@ursapharm.de.

ABSTRACT

Background: The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations, such as drug concentration.The aim of this study was to confirm that hydrocortisone acetate (HC-ac) ophthalmic ointments of 2.5% and 1% are more effective than a 0.5% eye ointment.

Methods: In this randomized, double-blind, placebo-controlled, parallel-group clinical study, the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 subjects.

Results: Median time to clinically relevant response as estimated by 50% reduction in clinical signs and symptoms (CSS) total score over the entire trial was similar for subjects treated with HC-ac 2.5% (73.5 h) and for subjects treated with HC-ac 1.0% (67.7 h) and was considerably and significantly longer for subjects treated with HC-ac 0.5% (111.8 h) [p < 0.001 for both dosages]. All trial medications were safe and well tolerated.

Conclusion: Hydrocortisone acetate 2.5% and Hydrocortisone acetate 1% eye ointments are efficacious and safe treatments for acute inflammations of the ocular surface or adnexa, and showed significantly better efficacy than a control group treated with Hydrocortisone acetate 0.5% therapy.

Trial registration: Current Controlled Trials ISRCTN15464650.

Show MeSH

Related in: MedlinePlus

Change from baseline to all post-baseline visits in CSS total score.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4061528&req=5

Figure 2: Change from baseline to all post-baseline visits in CSS total score.

Mentions: The results of the three hypotheses related to the primary efficacy variable demonstrated that median time as estimated by the Kaplan-Meier statistic to 50% reduction in CSS total score over the entire trial (ITT, N = 411) was similar for subjects treated with HC-ac 2.5% (73.5 h) and for subjects treated with HC-ac 1.0% (67.7 h) and was considerably and significantly longer for subjects treated with HC-ac 0.5% (111.8 h) [p < 0.001] (Figure 1).Baseline mean values of CSS sum score were very similar between treatments (HC-ac 2.5%: 16.1 points, HC-ac 1.0%: 16.3 points, and HC-ac 0.5%: 16.3 points). The mean reduction of the CSS total score between each trial visit and baseline increased progressively for all treatments (Figure 2); however, this reduction was higher in subjects treated with HC-ac 2.5% and HC-ac 1% compared with subjects treated with HC-ac 0.5% from Day 2 (Visit 1) to Day 10 (Visit 4) [p ≤ 0.001]. In addition, subjects treated with HC-ac 2.5% experienced a greater reduction in the score than subjects treated with HC-ac 0.5% in the last observation carried forward (LOCF) analysis (p = 0.022).


Hydrocortisone concentration influences time to clinically significant healing of acute inflammation of the ocular surface and adnexa - results from a double-blind randomized controlled trial.

Sergiyenko N, Sukhina L, Bezdetko P, Kovalenko Y, Nikitin N, Merzbacher M, Gross D, Kohnen R - BMC Ophthalmol (2014)

Change from baseline to all post-baseline visits in CSS total score.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4061528&req=5

Figure 2: Change from baseline to all post-baseline visits in CSS total score.
Mentions: The results of the three hypotheses related to the primary efficacy variable demonstrated that median time as estimated by the Kaplan-Meier statistic to 50% reduction in CSS total score over the entire trial (ITT, N = 411) was similar for subjects treated with HC-ac 2.5% (73.5 h) and for subjects treated with HC-ac 1.0% (67.7 h) and was considerably and significantly longer for subjects treated with HC-ac 0.5% (111.8 h) [p < 0.001] (Figure 1).Baseline mean values of CSS sum score were very similar between treatments (HC-ac 2.5%: 16.1 points, HC-ac 1.0%: 16.3 points, and HC-ac 0.5%: 16.3 points). The mean reduction of the CSS total score between each trial visit and baseline increased progressively for all treatments (Figure 2); however, this reduction was higher in subjects treated with HC-ac 2.5% and HC-ac 1% compared with subjects treated with HC-ac 0.5% from Day 2 (Visit 1) to Day 10 (Visit 4) [p ≤ 0.001]. In addition, subjects treated with HC-ac 2.5% experienced a greater reduction in the score than subjects treated with HC-ac 0.5% in the last observation carried forward (LOCF) analysis (p = 0.022).

Bottom Line: The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations, such as drug concentration.The aim of this study was to confirm that hydrocortisone acetate (HC-ac) ophthalmic ointments of 2.5% and 1% are more effective than a 0.5% eye ointment.In this randomized, double-blind, placebo-controlled, parallel-group clinical study, the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 subjects.Hydrocortisone acetate 2.5% and Hydrocortisone acetate 1% eye ointments are efficacious and safe treatments for acute inflammations of the ocular surface or adnexa, and showed significantly better efficacy than a control group treated with Hydrocortisone acetate 0.5% therapy.

View Article: PubMed Central - HTML - PubMed

Affiliation: URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany. d.gross@ursapharm.de.

ABSTRACT

Background: The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations, such as drug concentration.The aim of this study was to confirm that hydrocortisone acetate (HC-ac) ophthalmic ointments of 2.5% and 1% are more effective than a 0.5% eye ointment.

Methods: In this randomized, double-blind, placebo-controlled, parallel-group clinical study, the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 subjects.

Results: Median time to clinically relevant response as estimated by 50% reduction in clinical signs and symptoms (CSS) total score over the entire trial was similar for subjects treated with HC-ac 2.5% (73.5 h) and for subjects treated with HC-ac 1.0% (67.7 h) and was considerably and significantly longer for subjects treated with HC-ac 0.5% (111.8 h) [p < 0.001 for both dosages]. All trial medications were safe and well tolerated.

Conclusion: Hydrocortisone acetate 2.5% and Hydrocortisone acetate 1% eye ointments are efficacious and safe treatments for acute inflammations of the ocular surface or adnexa, and showed significantly better efficacy than a control group treated with Hydrocortisone acetate 0.5% therapy.

Trial registration: Current Controlled Trials ISRCTN15464650.

Show MeSH
Related in: MedlinePlus