Age Related CataractsPhase 1/2NCT06365762
The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract
A Phase 1/2 study testing EDTA Ophthalmic Solution 2.6% and EDTA Ophthalmic Solution 1.3% in people with Age Related Cataracts, run by Livionex Inc. at 6 sites in United States.
Trial summary
The study objectives were: To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity; To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and To determine the optimal clinical dose of EDTA ophthalmic… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Cataracts
- What is being tested?
- EDTA Ophthalmic Solution 2.6% and EDTA Ophthalmic Solution 1.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2006to 30 Apr 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 50 years of age
- Presence of early nuclear sclerosis cataract in both eyes below the level recommended for surgical replacement
- Both eyes having contrast sensitivity measurements of:
- Screening Visit:
- Less than or equal to 6, 4 and 4 in spatial frequencies C, D and E, respectively under mesopic illumination
- Baseline Visit:
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- Less than or equal to 6, 4 and 4 in spatial frequencies C, D and E, respectively under mesopic illumination and
- Greater than 0 in all five spatial frequencies (Patches A, B, C, D and E) under photopic illumination
- Best-Corrected Distance Visual Acuity (BCDVA) measurement by ETDRS of better than or equal to 20/50 in both eyes attributable to low- grade nuclear cataract
- Patient must be willing and able to provide written informed consent
- Patient must be willing and able to comply with study visits as described in the protocol
Who cannot join
- Clinical evidence of any active ocular infection (i.e., bacterial, viral, parasitic or fungal) in either eye
- History of herpetic ocular infection in either eye
- Presence or history of glaucoma in either eye
- Presence or history of intraocular pressure of >22 mm Hg in either eye
- Amblyopia in either eye
- Presence of any corneal disorder including pterygium or superficial keratitis
Show all 22Show fewer
- Dry eyes which require the use of a prescription medication
- Presence of posterior subcapsular cataract
- Presence of cortical cataract that intrudes within the central 4mm of the lens
- Presence or history of any ocular inflammatory disorder in either eye (e.g., uveitis, ocular allergies)
- Patients with known allergies to EDTA preservatives
- Presence of any optic nerve or retinal disorders including, but not limited to, age-related macular degeneration, optic neuropathy, etc. in either eye
- Prior intraocular, refractive and/or laser surgery of any type in either eye
- Anticipated need for ocular surgery in either eye within six months of study enrollment
- History of diabetes
- Pseudo-exfoliation syndrome
- Contact lens use (soft contact lens wear within 2 weeks of the date of randomization, rigid lens wear within three months of the date of randomization. No contact lens use throughout duration of the study)
- Current use or anticipated use of any ocular medications (over-the- counter or prescription). Use of topical ophthalmic drugs should be discontinued 14 days prior to enrollment into the treatment arm of the study
- Current or anticipated use of any systemic or ocular steroids or chronic use of topical steroids within 30 days of study enrollment
- Females who are pregnant, lactating or pre- or peri menopausal and unwilling to use adequate birth control for the duration of the study
- Participation in an investigational device or drug trial within the last 30 day
- Presence of any condition, abnormality or situation at Screening or at Baseline that in the opinion of the Principal Investigator may preclude the patient's ability to comply with study requirements, including completion of the study or the quality of the data
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Harvard Medical School, Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Charlotte Eye, Ear, Nose, and Throat Associates
Charlotte, North Carolina, 28210
The Johns Hopkins Hospital & Health System, Wilmer Eye Institute
Lutherville, Maryland, 21093
Hunkeler Eye Institute
Overland Park, Kansas, 66210
University of Utah, John Moran Eye Center
Salt Lake City, Utah, 84132
St Mary's Eye Specialists, Inc.
San Francisco, California, 94117
About this study
Official title: A Phase 1/2, Randomized, Placebo-Controlled, Double-Masked, Multicenter, Dose-Ranging, Safety and Efficacy of C-KAD Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract
The study objectives were:
- To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity;
- To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and
- To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s).
Read the detailed description
This was a prospective, randomized, placebo-controlled, double-masked, parallel evaluation of the safety and efficacy of EDTA ophthalmic solution in patients with loss of contrast sensitivity due to age-related, low-grade cataract.
111 subjects were enrolled at six study sites within the U.S. and randomly assigned in 1:1:1 ratio to treatment with 2.6% C-KAD, 1.3% C-KAD and placebo. The treatment duration was 120 days with a run-in period and follow-up period of 14 days each.
During the Run-in Period, patients received pre-treatment with lubricating eye drops (Refresh® Plus Lubricant Eye Drops) in both eyes to ensure uniformity in the level of ocular hydration at Baseline in patients randomized into the study.
Patients were evaluated at a Screening Visit (Day -14), at Baseline (Day 0), during the dosing period (Days 30, 60, 90, 120) and at the Follow-up Visit (Day 134), two weeks after completion of active treatment.
Tolerability and efficacy were assessed by Slit Lamp and Fundus Examinations, Best-Corrected Distance Visual Acuity, Contrast Sensitivity, Endothelial Cell Count, Pentacam Imaging, Tear Film Break-Up Time, IOP measurements, Pupil Size measurement and evaluation of Adverse Events.
- Conditions
- Age Related Cataracts
- Being tested
- EDTA Ophthalmic Solution 2.6%, EDTA Ophthalmic Solution 1.3%, Saline Solution (Placebo)
- Keywords
- Contrast Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDTA Ophthalmic Solution 2.6%Drug
Also called C-KAD 2.6%
EDTA Ophthalmic Solution 1.3%Drug
Also called C-KAD 1.3%
Saline Solution (Placebo)Drug
Also called Software Saline
| Study group | Role | What they receive |
|---|---|---|
| C-KAD 2.6% | Experimental | Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days Receives: Drug: EDTA Ophthalmic Solution 2.6% |
| C-KAD 1.3% | Experimental | Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days Receives: Drug: EDTA Ophthalmic Solution 1.3% |
| Placebo | Placebo comparator | Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days Receives: Drug: Saline Solution (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Sensitivity (Mesopic) Responder Analysis
Proportion of patients with ≥ 2-patch (0.30 logCS) contrast sensitivity improvement in at least two spatial frequencies under mesopic illumination
Measured: Baseline, Days 30, 60, 90, and 120
Secondary outcomes (1)
Cumulative Improvement in Contrast Sensitivity (Mesopic)
total changes in patches of contrast sensitivity measurements across all five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree)
Measured: Baseline, Days 30, 60, 90, and 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jan 2006
- Primary completion31 Dec 2006
- Study completion30 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related CataractsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livionex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365762
- Sponsor's protocol ID
- CK-0103
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Placebo-Controlled, Double-Masked, Multicenter, Dose-Ranging, Safety and Efficacy of C-KAD Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract
- ClinicalTrials.gov ID
- NCT06365762
- Acronym / sponsor ID
- CK-0103
- Conditions
- Age Related Cataracts
- Keywords
- Contrast Sensitivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Livionex Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2006 (actual)
- Study completion
- 30 Apr 2007 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives were:
- To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity;
- To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and
- To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s).
Detailed description
This was a prospective, randomized, placebo-controlled, double-masked, parallel evaluation of the safety and efficacy of EDTA ophthalmic solution in patients with loss of contrast sensitivity due to age-related, low-grade cataract.
111 subjects were enrolled at six study sites within the U.S. and randomly assigned in 1:1:1 ratio to treatment with 2.6% C-KAD, 1.3% C-KAD and placebo. The treatment duration was 120 days with a run-in period and follow-up period of 14 days each.
During the Run-in Period, patients received pre-treatment with lubricating eye drops (Refresh® Plus Lubricant Eye Drops) in both eyes to ensure uniformity in the level of ocular hydration at Baseline in patients randomized into the study.
Patients were evaluated at a Screening Visit (Day -14), at Baseline (Day 0), during the dosing period (Days 30, 60, 90, 120) and at the Follow-up Visit (Day 134), two weeks after completion of active treatment.
Tolerability and efficacy were assessed by Slit Lamp and Fundus Examinations, Best-Corrected Distance Visual Acuity, Contrast Sensitivity, Endothelial Cell Count, Pentacam Imaging, Tear Film Break-Up Time, IOP measurements, Pupil Size measurement and evaluation of Adverse Events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C-KAD 2.6% | Experimental | Drug: EDTA Ophthalmic Solution 2.6%Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days |
| C-KAD 1.3% | Experimental | Drug: EDTA Ophthalmic Solution 1.3%Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days |
| Placebo | Placebo comparator | Drug: Saline Solution (Placebo)Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients ≥ 50 years of age
- Presence of early nuclear sclerosis cataract in both eyes below the level recommended for surgical replacement
- Both eyes having contrast sensitivity measurements of:
- Best-Corrected Distance Visual Acuity (BCDVA) measurement by ETDRS of better than or equal to 20/50 in both eyes attributable to low- grade nuclear cataract
- Patient must be willing and able to provide written informed consent
Key exclusion criteria (22 listed)
- Clinical evidence of any active ocular infection (i.e., bacterial, viral, parasitic or fungal) in either eye
- History of herpetic ocular infection in either eye
- Presence or history of glaucoma in either eye
- Presence or history of intraocular pressure of >22 mm Hg in either eye
- Amblyopia in either eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDTA Ophthalmic Solution 2.6%Also: C-KAD 2.6% | Drug | C-KAD 2.6% |
| EDTA Ophthalmic Solution 1.3%Also: C-KAD 1.3% | Drug | C-KAD 1.3% |
| Saline Solution (Placebo)Also: Software Saline | Drug | Placebo |
Primary outcome
Contrast Sensitivity (Mesopic) Responder Analysis
Time frame: Baseline, Days 30, 60, 90, and 120
Proportion of patients with ≥ 2-patch (0.30 logCS) contrast sensitivity improvement in at least two spatial frequencies under mesopic illumination
1 secondary outcome
Cumulative Improvement in Contrast Sensitivity (Mesopic)
Time frame: Baseline, Days 30, 60, 90, and 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EDTA Ophthalmic Solution 2.6% and EDTA Ophthalmic Solution 1.3% in people with Age Related Cataracts, run by Livionex Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast Sensitivity (Mesopic) Responder Analysis (time frame: Baseline, Days 30, 60, 90, and 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.