The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Pa… (NCT06365762) | Clinical Trial Compass
CompletedPhase 1/2
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
United States111 participantsStarted 2006-01-01
Plain-language 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 solution (C-KAD) which to proceed into pivotal study(s).
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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:
* 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
Exclusion Criteria:
* 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
* Dry eyes which require the use of a prescription medication
* Presence of posterior subcapsular cataract
* Presence of cortical cataract that intrudes …