Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery

Thea Pharma

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: Mydriatics; Drug: Tetracaine; Drug: T2380

Study type: Interventional

Funder types: Industry

Identifiers

NCT02101359

LT2380-PIII-05/10

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.

Full description

In order to perform pupil size measurements and ocular discomfort assessments at specific times, the surgical procedure was divided into 5 time periods according to the following time points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before cefuroxime injection).

Enrollment: 609 patients

Sex: All

Ages: 40 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent
• Male or female aged from 40 to 88 years old
• Scheduled to undergo unilateral cataract surgery

Exclusion criteria

• Combined surgery
• Previous intraocular surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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609 participants in 2 patient groups

T2380

Experimental group

Description:

Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. At the beginning of surgery, 200 μL of T2380 were administrated intracamerally.

Treatment:

Drug: Tetracaine

Drug: T2380

Mydriatics and anesthetic

Active Comparator group

Description:

Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. Topical Mydriatic treatments were instilled three times before surgery.

Treatment:

Drug: Tetracaine

Drug: Mydriatics