Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost
A Pilot, Single-Masked Study to Compare the Safety and Efficacy of ALZ-1101 (Latanoprost 0.005%/Dorzolamide 2.0%) to Latanoprost Ophthalmic Solution, 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension With Intraocular Pressure Inadequately Controlled By Latanoprost
調査の概要
詳細な説明
This is an exploratory, pilot, proof of concept Phase 2 study. The objectives include the comparison of efficacy of ALZ-1101 to latanoprost 0.005% ophthalmic solution in reducing elevated intraocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension who have IOP not adequately controlled with latanoprost.
70 Subjects (35 per arm) will be treated once daily (QD) in the evening with either ALZ-1101 or latanoprost for 28 days.
Efficacy will be assessed at 3 separate times (8 AM, 10 AM and 4 PM) on each treatment visit (Days 0, 7, 14 and 28) by Goldmann applanation tonometry.
Safety assessments will include slit lamp examination/anterior chamber cell and flare grading, ophthalmoscopy/fundus examination, visual acuity, visual field testing and colelction of adverse events. Subject rating of study medication comfort will be collected at each visit.
Primary efficacy endpoint is the between-group comparison of the mean IOP at the 10 am time point at visit 5 (Day 28). Secondary endpoints include the between-group comparisons of the mean change from baseline in IOP at all time-points, between group comparison of the mean change from baseline in diurnal IOP at all post-baseline visits and the proportion of subjects with IOP ≤ 18 mm Hg at all time points at all post-baseline visits.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Georgia
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Morrow、Georgia、アメリカ
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18 years or older.
- Primary open-angle glaucoma or OH on treatment with latanoprost 0.005% QD.
- At least one eye with IOP > 18 mm Hg but ≤ 28 mm Hg at all time points (8 AM, 10 AM, and 4 PM) while on latanoprost monotherapy QD at Screening and Baseline (Day 0) visits. Measurements will be taken each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes), with AM measurements of IOP at least 2 hours apart. Screening must be at least one week before but within 2 weeks prior to Baseline.
- On latanoprost 0.005% QD for at least 4 weeks prior to randomization.
- Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.
- Stable corrected Snellen visual acuity (VA) better than 20/200 in the study eye.
- Central corneal thickness between 480-620 μm in the study eye.
- Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
- Provide signed written consent prior to participation in any study-related procedures.
Exclusion Criteria:
- A mean deviation of < -20 dB on visual field (VF) assessment.
- Presence of a scotoma within 5°of fixation on VF.
- Aphakia.
- Use of any antiglaucoma medication in addition to latanoprost QD within 2 weeks prior to Visit 1 or during the study period.
- Use of any topical ophthalmic steroid or nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Visit 1 or during the study period.
- Use of systemic carbonic anhydrase inhibitor within 2 weeks prior to Visit 1 or during the study period.
- Ocular surgery or ocular laser treatment of any kind within 3 months prior to Visit 1 or during the study period.
- Any history of glaucoma surgery (laser or non-laser).
- History of ocular allergy/inflammation and/or severe blepharitis and/or uveitis. Seasonal allergic conjunctivitis is acceptable (avoid enrollment of subjects who may experience seasonal flare-up during the study period). Mild blepharitis/blepharoconjunctivitis, typically associated with prostaglandin usage, is acceptable.
- History of ocular trauma or ocular infection within 3 months of Visit 1.
- History of herpes simplex keratitis.
- Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
- Severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial erosions of the cornea, and/or use of dry eye medication [including artificial tears] with a frequency exceeding 8 applications per day).
- Contact lens wear within one week prior to Visit 1 or during the study period (contact lens wear in an untreated fellow eye is allowed).
- Angle closure or occludable angles (Shaffer gonioscopic grade of < 3).
- Cataract that compromises visualization of the fundus.
- Cup-to-disc (C/D) ratio of > 0.8.
- Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
- Pregnancy or lactation.
- Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline directed therapy).
- Allergy to prostaglandin analogues or carbonic anhydrase inhibitors.
- Allergy to benzalkonium chloride.
- History of moderate or severe renal or hepatic impairment.
- Participation in any study of an investigational product within 30 days prior to Visit 1 or at any time during the study period.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:ALZ-1101
ALZ-1101 ophthalmic solution dosed as 1 drop, once daily in the evening via topical ocular adminstration
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ALZ-1101 Ophthalmic Solution
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アクティブコンパレータ:Latanoprost
Latanoprost 0.005% ophthalmic solution dosed as 1 drop, once daily in the evening via topical ocular administration
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Latanoprost 0.005% Ophthalmic Solution
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Goldmann applanation tonometry
時間枠:28 days
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Between-group comparison of the mean IOP values at the 10 AM time point at Visit 5 (Day 28).
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28 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Goldmann applanation tonometry
時間枠:28 days
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Between-group comparison of the mean change from baseline in IOP at all time points at all post-baseline visits
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28 days
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Goldmann applanation tonometry
時間枠:28 days
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Between-group comparison of the mean change from baseline in diurnal IOP at all post baseline visits
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28 days
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Goldmann applanation tonometry
時間枠:28 days
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The proportion of subjects with IOP ≤ 18 mm Hg at all time points at all post-baseline visits
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28 days
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Safety
時間枠:28 days
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Assessment of the safety and tolerability will be assessed by slit lamp examination/anterior chamber cell and flare grading, ophthalmoscopy (cup-to-disc ratio)/dilated fundus examination, corrected Snellen visual acuity, VF testing, and adverse event assessment.
Comfort data (subjective) will also be collected at each visit.
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28 days
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
ALZ-1101の臨床試験
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Alzheon Inc.招待による登録早期アルツハイマー病アメリカ, スペイン, カナダ, オランダ, チェコ, イギリス, フランス, ドイツ, アイスランド
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Alzheon Inc.National Institute on Aging (NIA)積極的、募集していない早期アルツハイマー病アメリカ, スペイン, カナダ, オランダ, チェコ, イギリス, フランス, ドイツ, アイスランド
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Alzinova ABCRST Oy募集
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TG Therapeutics, Inc.募集