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Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials.

McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA - Adv Ther (2014)

Bottom Line: Treatment with alcaftadine 0.25% and olopatadine 0.2% was safe and well tolerated; no serious adverse events were reported.Once-daily alcaftadine 0.25% ophthalmic solution demonstrated greater efficacy in prevention of ocular itching compared with olopatadine 0.2% at 3 min post-CAC (primary endpoint), and over all time points, 16 h post-treatment instillation.Alcaftadine and olopatadine both provided effective relief compared with placebo and were generally well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Total Eye Care, P. A., 6060 Primacy Parkway, Suite 200, Memphis, TN, 38119, USA, totaleyeresearch@mac.com.

ABSTRACT

Introduction: The efficacy and safety of the once-daily topical ophthalmic solutions, alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.

Methods: Pooled analysis was conducted of two double-masked, multicenter, active- and placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Subjects were randomized 1:1:1 to receive alcaftadine 0.25%, olopatadine 0.2%, or placebo. The primary efficacy measure was subject-evaluated mean ocular itching at 3 min post-CAC and 16 h after treatment instillation. Secondary measures included ocular itching at 5 and 7 min post-CAC. Ocular itch was determined over all time points measured (3, 5, and 7 min) post-CAC and the proportion of subjects with minimal itch (itch score<1) and zero itch (itch score=0) was also assessed.

Results: A total of 284 subjects were enrolled in the two studies. At 3 min post-CAC and 16 h after treatment instillation, alcaftadine 0.25% achieved a significantly lower mean itch score compared with olopatadine 0.2% (0.50 vs. 0.87, respectively; P=0.0006). Alcaftadine demonstrated a significantly lower mean itch score over all time points compared with olopatadine (0.68 vs. 0.92, respectively; P=0.0390); both alcaftadine- and olopatadine-treated subjects achieved significantly lower overall mean ocular itching scores compared with placebo (2.10; P<0.0001 for both actives). Minimal itch over all time points was reported by 76.1% of alcaftadine-treated subjects compared with 58.1% of olopatadine-treated subjects (P=0.0121). Treatment with alcaftadine 0.25% and olopatadine 0.2% was safe and well tolerated; no serious adverse events were reported.

Conclusion: Once-daily alcaftadine 0.25% ophthalmic solution demonstrated greater efficacy in prevention of ocular itching compared with olopatadine 0.2% at 3 min post-CAC (primary endpoint), and over all time points, 16 h post-treatment instillation. Alcaftadine and olopatadine both provided effective relief compared with placebo and were generally well tolerated.

No MeSH data available.


Related in: MedlinePlus

Comparison of overall mean itch scores at baseline and 16 h after treatment instillation over all time points (3, 5, and 7 min) post-conjunctival allergen challenge. Mean itch scores for alcaftadine 0.25%, olopatadine 0.2%, and placebo. *P < 0.0001 for alcaftadine and olopatadine versus placebo; **P = 0.0390 for alcaftadine versus olopatadine. P values calculated using the repeated measures analysis of covariance model accounting for treatment and time points
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Fig3: Comparison of overall mean itch scores at baseline and 16 h after treatment instillation over all time points (3, 5, and 7 min) post-conjunctival allergen challenge. Mean itch scores for alcaftadine 0.25%, olopatadine 0.2%, and placebo. *P < 0.0001 for alcaftadine and olopatadine versus placebo; **P = 0.0390 for alcaftadine versus olopatadine. P values calculated using the repeated measures analysis of covariance model accounting for treatment and time points

Mentions: For the primary efficacy endpoint, ocular itching at 3 min post-CAC and 16 h after treatment instillation, alcaftadine 0.25% achieved a statistically significant lower mean itch score compared with olopatadine 0.2% (0.50 vs. 0.87, respectively; P = 0.0006; Fig. 2). Analysis over all the time points measured (3, 5, and 7 min) also demonstrated a statistically lower overall mean itch score with alcaftadine 0.25% compared with olopatadine 0.2% (0.68 vs. 0.92, respectively; P = 0.0390; Fig. 3). Both alcaftadine 0.25% and olopatadine 0.2% were superior to placebo for achieving greater reductions in mean itch scores at 3, 5, and 7 min post-CAC and over all time points (P < 0.0001 for both alcaftadine and olopatadine versus placebo; Table 2). Alcaftadine 0.25%-treated subjects consistently demonstrated greater percentage reduction in itching from baseline at 3, 5, and 7 min post-CAC (−81.0%, −74.1%, and −70.6%, respectively) compared with olopatadine 0.2%-treated subjects (−63.2%, −65.7%, and −65.2%, respectively). For both actives, the percentage reduction in itching from baseline was superior over placebo at 3, 5, and 7 min (−23.7%, −24.1%, and −30.2%, respectively).Fig. 2


Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials.

McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA - Adv Ther (2014)

Comparison of overall mean itch scores at baseline and 16 h after treatment instillation over all time points (3, 5, and 7 min) post-conjunctival allergen challenge. Mean itch scores for alcaftadine 0.25%, olopatadine 0.2%, and placebo. *P < 0.0001 for alcaftadine and olopatadine versus placebo; **P = 0.0390 for alcaftadine versus olopatadine. P values calculated using the repeated measures analysis of covariance model accounting for treatment and time points
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Related In: Results  -  Collection

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Fig3: Comparison of overall mean itch scores at baseline and 16 h after treatment instillation over all time points (3, 5, and 7 min) post-conjunctival allergen challenge. Mean itch scores for alcaftadine 0.25%, olopatadine 0.2%, and placebo. *P < 0.0001 for alcaftadine and olopatadine versus placebo; **P = 0.0390 for alcaftadine versus olopatadine. P values calculated using the repeated measures analysis of covariance model accounting for treatment and time points
Mentions: For the primary efficacy endpoint, ocular itching at 3 min post-CAC and 16 h after treatment instillation, alcaftadine 0.25% achieved a statistically significant lower mean itch score compared with olopatadine 0.2% (0.50 vs. 0.87, respectively; P = 0.0006; Fig. 2). Analysis over all the time points measured (3, 5, and 7 min) also demonstrated a statistically lower overall mean itch score with alcaftadine 0.25% compared with olopatadine 0.2% (0.68 vs. 0.92, respectively; P = 0.0390; Fig. 3). Both alcaftadine 0.25% and olopatadine 0.2% were superior to placebo for achieving greater reductions in mean itch scores at 3, 5, and 7 min post-CAC and over all time points (P < 0.0001 for both alcaftadine and olopatadine versus placebo; Table 2). Alcaftadine 0.25%-treated subjects consistently demonstrated greater percentage reduction in itching from baseline at 3, 5, and 7 min post-CAC (−81.0%, −74.1%, and −70.6%, respectively) compared with olopatadine 0.2%-treated subjects (−63.2%, −65.7%, and −65.2%, respectively). For both actives, the percentage reduction in itching from baseline was superior over placebo at 3, 5, and 7 min (−23.7%, −24.1%, and −30.2%, respectively).Fig. 2

Bottom Line: Treatment with alcaftadine 0.25% and olopatadine 0.2% was safe and well tolerated; no serious adverse events were reported.Once-daily alcaftadine 0.25% ophthalmic solution demonstrated greater efficacy in prevention of ocular itching compared with olopatadine 0.2% at 3 min post-CAC (primary endpoint), and over all time points, 16 h post-treatment instillation.Alcaftadine and olopatadine both provided effective relief compared with placebo and were generally well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Total Eye Care, P. A., 6060 Primacy Parkway, Suite 200, Memphis, TN, 38119, USA, totaleyeresearch@mac.com.

ABSTRACT

Introduction: The efficacy and safety of the once-daily topical ophthalmic solutions, alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.

Methods: Pooled analysis was conducted of two double-masked, multicenter, active- and placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Subjects were randomized 1:1:1 to receive alcaftadine 0.25%, olopatadine 0.2%, or placebo. The primary efficacy measure was subject-evaluated mean ocular itching at 3 min post-CAC and 16 h after treatment instillation. Secondary measures included ocular itching at 5 and 7 min post-CAC. Ocular itch was determined over all time points measured (3, 5, and 7 min) post-CAC and the proportion of subjects with minimal itch (itch score<1) and zero itch (itch score=0) was also assessed.

Results: A total of 284 subjects were enrolled in the two studies. At 3 min post-CAC and 16 h after treatment instillation, alcaftadine 0.25% achieved a significantly lower mean itch score compared with olopatadine 0.2% (0.50 vs. 0.87, respectively; P=0.0006). Alcaftadine demonstrated a significantly lower mean itch score over all time points compared with olopatadine (0.68 vs. 0.92, respectively; P=0.0390); both alcaftadine- and olopatadine-treated subjects achieved significantly lower overall mean ocular itching scores compared with placebo (2.10; P<0.0001 for both actives). Minimal itch over all time points was reported by 76.1% of alcaftadine-treated subjects compared with 58.1% of olopatadine-treated subjects (P=0.0121). Treatment with alcaftadine 0.25% and olopatadine 0.2% was safe and well tolerated; no serious adverse events were reported.

Conclusion: Once-daily alcaftadine 0.25% ophthalmic solution demonstrated greater efficacy in prevention of ocular itching compared with olopatadine 0.2% at 3 min post-CAC (primary endpoint), and over all time points, 16 h post-treatment instillation. Alcaftadine and olopatadine both provided effective relief compared with placebo and were generally well tolerated.

No MeSH data available.


Related in: MedlinePlus