Status:
COMPLETED
Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Dry Eye Syndromes
Cataract
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
Clinical trial with medical devices, post-authorization, parallel, single-blind, randomized, comparative, prospective to study how afects the quality of life the use of ocular eye drops on patients wi...
Eligibility Criteria
Inclusion
- Subjects between the ages of 50 and 70.
- Subjects with initial or slight changes characteristic of cataracts (grade 1-3 according to LOCS III classification).
- Subjects with dry eye symptoms.
- Confirmation of senile cataract diagnosis according to medical history and clinical observations, bilateral.
- Visual acuity equal to or greater than (0.6) in both eyes (with the best correction).
- Cataracts without the need for surgical intervention in the near future (1 year) based on the visual needs of the patient and ocular symptomatology.
- Subjects that have not undergone cataract surgery.
- Cases that do not accept surgery (weak corneas, high degree of myopia, sensitivity to light, severe dryness of the eyes or by their own decision).
- Subjects who agree to sign the IC (Informed Consent).
Exclusion
- Subjects with eye diseases such as glaucoma or diabetic retinopathy.
- Previous laser photocoagulation of the retina.
- Previous corneal or anterior segment surgery or previous corneal scars that may interfere with visualization or photographs.
- Presence of mature cataracts (grade 4-5/6 according to LOCS III classification) in both eyes.
- Candidates for surgery in the following year.
- Subjects with monocular aphakia (absence of crystalline lens) or secondary cataracts (associated with steroid use, local or total irradiation, local inflammation or degenerative processes, ocular trauma).
- Subjects with known hypersensitivity to any component of ophthalmic treatment.
- Subjects treated with drugs that may interfere with the evolution of the disease under study.
- Subjects who wear contact lenses.
- Pregnant women.
- Breastfeeding women.
- Subjects who have participated in another clinical trial within the last 30 days.
- Subjects with linguistic or psychological incapacity to understand and sign the CI.
Key Trial Info
Start Date :
May 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04063644
Start Date
May 30 2019
End Date
December 22 2020
Last Update
March 23 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041