Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract

Chakshu Research

Status and phase: Unknown; Phase 2

Conditions: Cataract

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793091

CK-0109

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of age-related cataract in the study eye
• Best-corrected visual acuity of 20/25 to 20/50 in the study eye

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

---

80 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: C-KAD Ophthalmic Solution

2

Placebo Comparator group

Treatment:

Drug: Placebo