Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract

Chakshu Research

Status and phase: Unknown; Phase 2

Conditions: Nuclear Cataract

Treatments: Drug: LiquiTears; Drug: C-KAD Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00825721

CK-0105

Details and patient eligibility

About

This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract

Enrollment: 81 patients

Sex: All

Ages: 35 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of nuclear sclerosis cataract
• BCDVA within the range of 20/40 and 20/80

Exclusion criteria

• Any other clinical condition in the eye that may compromise vision
• Presence or history of glaucoma
• Presence or history of diabetes
• Use of eyedrops
• Use of steroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 4 patient groups, including a placebo group

1.3% (low dose)

Active Comparator group

Treatment:

Drug: C-KAD Ophthalmic Solution

Drug: C-KAD Ophthalmic Solution

Drug: C-KAD Ophthalmic Solution

2% (medium dose)

Active Comparator group

Treatment:

Drug: C-KAD Ophthalmic Solution

Drug: C-KAD Ophthalmic Solution

Drug: C-KAD Ophthalmic Solution

2.6% (high dose)

Active Comparator group

Treatment:

Drug: C-KAD Ophthalmic Solution

Drug: C-KAD Ophthalmic Solution

Drug: C-KAD Ophthalmic Solution

Placebo

Placebo Comparator group

Treatment:

Drug: LiquiTears