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

NCT ID: NCT00825721

Last Updated: 2009-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Nuclear Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1.3% (low dose)

Group Type ACTIVE_COMPARATOR

C-KAD Ophthalmic Solution

Intervention Type DRUG

4 drops applied daily for 360 days

2% (medium dose)

Group Type ACTIVE_COMPARATOR

C-KAD Ophthalmic Solution

Intervention Type DRUG

4 drops applied daily for 360 days

2.6% (high dose)

Group Type ACTIVE_COMPARATOR

C-KAD Ophthalmic Solution

Intervention Type DRUG

4 drops applied daily for 360 days

Placebo

Group Type PLACEBO_COMPARATOR

LiquiTears

Intervention Type DRUG

4 drops applied daily for 360 days

Interventions

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LiquiTears

4 drops applied daily for 360 days

Intervention Type DRUG

C-KAD Ophthalmic Solution

4 drops applied daily for 360 days

Intervention Type DRUG

C-KAD Ophthalmic Solution

4 drops applied daily for 360 days

Intervention Type DRUG

C-KAD Ophthalmic Solution

4 drops applied daily for 360 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chakshu Research, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Chakshu Reserach, Inc.

Principal Investigators

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Sanduk Ruit, MD

Role: PRINCIPAL_INVESTIGATOR

Tilganga Eye Center

Reeta Gurung, MD

Role: PRINCIPAL_INVESTIGATOR

Tilganga Eye Center

Locations

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Tilganga Eye Center

Kathmandu, Kathmandu, Nepal

Site Status

Countries

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Nepal

Other Identifiers

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CK-0105

Identifier Type: -

Identifier Source: org_study_id

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