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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.

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Related in: MedlinePlus

Change from baseline to Day 10 in CSS total score for subjective symptoms (A) and objective symptoms (B).
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Figure 3: Change from baseline to Day 10 in CSS total score for subjective symptoms (A) and objective symptoms (B).

Mentions: Tolerability was not a major treatment issue, with only 2.2% of subjects in total experiencing mild to moderate AEs: increased lacrimation, conjunctival hyperemia, and pruritus/discomfort at the application site. Only two subjects discontinued from the study prematurely because of AEs. In addition, visual acuity and IOP values were within the normal ranges at baseline and at the end of the study, and no clinically relevant changes were reported throughout the 2-week treatment duration. No instances of cataract formation were observed.Subjects with baseline moderate to severe symptoms of acute inflammation of mostly allergic blepharoconjunctivitis (43%), as well as allergic blepharitis (39%) or allergic conjuncitivitis (18%) were treated. Most severe symptoms were foreign body sensations in the eye, itching, red or swollen eyelids, and conjunctival hyperemia (Figure 3), whereas yellowish discharge was present in only a few subjects. Non-response to other therapies was not an inclusion criterion; therefore, our conclusions cannot be extended to this treatment-refractory sub-population of subjects with allergic conjunctivitis.


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 Day 10 in CSS total score for subjective symptoms (A) and objective symptoms (B).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 3: Change from baseline to Day 10 in CSS total score for subjective symptoms (A) and objective symptoms (B).
Mentions: Tolerability was not a major treatment issue, with only 2.2% of subjects in total experiencing mild to moderate AEs: increased lacrimation, conjunctival hyperemia, and pruritus/discomfort at the application site. Only two subjects discontinued from the study prematurely because of AEs. In addition, visual acuity and IOP values were within the normal ranges at baseline and at the end of the study, and no clinically relevant changes were reported throughout the 2-week treatment duration. No instances of cataract formation were observed.Subjects with baseline moderate to severe symptoms of acute inflammation of mostly allergic blepharoconjunctivitis (43%), as well as allergic blepharitis (39%) or allergic conjuncitivitis (18%) were treated. Most severe symptoms were foreign body sensations in the eye, itching, red or swollen eyelids, and conjunctival hyperemia (Figure 3), whereas yellowish discharge was present in only a few subjects. Non-response to other therapies was not an inclusion criterion; therefore, our conclusions cannot be extended to this treatment-refractory sub-population of subjects with allergic conjunctivitis.

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