中等度の症候性ドライアイ疾患の成人におけるINV-102点眼液の研究
第 1/2 相、多施設、無作為化、二重マスク、ビヒクル制御、複数の漸増用量 (パート 1) およびオプションの用量拡大 (パート 2) 中等度の症候性ドライアイ疾患の成人被験者における INV-102 点眼薬の研究
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic dry eye disease.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
New York
-
Rush、New York、アメリカ、14543
- iuvo BioScience
-
-
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
Key Inclusion Criteria:
- Healthy male or female subject ≥18 years of age
- Presence of moderate DED in at least one eye
Key Exclusion Criteria:
- Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior
- Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- External eye disease except primary DED
- Systemic disease associated with DED
- History or evidence of ocular infection within the previous 30 days
- History or evidence of ocular herpes simplex or ocular herpes zoster
- Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：INV-102 0.1% Twice daily (BID)
Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
実験的：INV-102 0.25% BID
Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
実験的：INV-102 0.7% BID
Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
実験的：INV-102 0.7% Three times daily (TID)
Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
実験的：INV-102 TBD% BID
Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4 |
INV-102 Ophthalmic Solution |
|
プラセボコンパレーター：Vehicle
Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks |
Vehicle Ophthalmic Solution |
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 |
|---|---|---|
|
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event
時間枠：From first dose through study completion (Day 22)
|
The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens. |
From first dose through study completion (Day 22)
|
|
Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)
時間枠：Day 15
|
The primary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Score in the study eye from the DED symptom VAS. The dry eye disease symptom visual analog scale consisted of various DED symptom parameters and was completed by subjects for each eye individually. Subjects were asked to rate their discomfort from 0 (no discomfort) to 100 (maximal discomfort) for each of the DED symptoms by placing a single vertical mark on a horizontal line based on the extent of their symptoms. |
Day 15
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score
時間枠：Day 15
|
The secondary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Composite Score in the study eye. The eye dryness composite score (points) combines the change from Baseline in eye dryness score from the DED symptom VAS and the change from Baseline in corneal fluorescein staining score. VAS eye dryness scores were rated by subjects on a scale of 0 (no discomfort) to 100 (maximal discomfort). Corneal fluorescein staining assessments were performed using the National Eye Institute/Industry grading scale to score each of 5 corneal zones on a 0 (no ocular surface disease) to 3 (severe ocular surface disease) scale (with a total score of 0 to 15). The calculated eye dryness composite score can range from -100 points to 100 points (positive values indicate worsening of dry eye disease signs and symptoms; negative values indicate improvement). |
Day 15
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Robert Shalwitz, MD、Invirsa, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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