NCT00825721UnknownPhase 2
A Randomized, Placebo-Controlled, Single-Masked, Dose-Ranging Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataracts
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Chakshu Research, Inc.
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Best-corrected visual acuity by ETDRS
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1.3% (low dose)
Active Comparator
Intervention: C-KAD Ophthalmic Solution (Drug)
2% (medium dose)
Active Comparator
Intervention: C-KAD Ophthalmic Solution (Drug)
2.6% (high dose)
Active Comparator
Intervention: C-KAD Ophthalmic Solution (Drug)
Placebo
Placebo Comparator
Intervention: LiquiTears (Drug)
Outcomes
Primary Outcomes
Best-corrected visual acuity by ETDRS
Time Frame: 360 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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