An interventional study of Hyper-CL™ lens and Regular soft contact lens in CORNEAL EDEMA, sponsored by Eye-yon Medical. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by Eye-yon Medical · Not applicable, Interventional, and Treatment
The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
In addition Hyper-CL™ contact lenses can also provide optical correction during healing if required.
This study is a prospective, randomized crossover study. The primary aim of this study is to assess the safety and effectiveness of using the Hyper-CL™ lens +salt solution (5% NaCl) as compared with using regular contact lens + salt solution (5% NaCl) in subjects suffering from corneal edema. Safety will be assessed by evaluating the rate of adverse events and adverse device effects occurred throughout the study period. Effectiveness will be assessed by measuring changes in corneal thickness and visual acuity.
Subjects with corneal edema will be the study population. Only subjects who have signed the informed consent form and meet all the eligibility criteria listed below will be qualified for enrollment. The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule.
Each subject will be treated with:
Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments. Subject will be equally allocated to one of the following 2 crossover regimen based on a randomization scheme with blocks stratified by center: A-B; B-A
45 studies on the registry are indexed under Corneal Edema; 7 are open to participants now.
This study's enrollment of 68 is above the median of 42 across 37 interventional studies indexed under Corneal Edema.
Browse Corneal Edema studies →Eye-yon Medical is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments.
Device: Hyper-CL™ lens · Device: Regular soft contact lens · Drug: Salt solution
Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments.
Device: Hyper-CL™ lens · Device: Regular soft contact lens · Drug: Salt solution
frequency and severity of all treatment-related adverse events
Time frame: Up to 28 days (or 21 days if wash out is not needed).
Percent of subjects with corneal thickness decrease of at least 8% and or visual acuity improvement of at least 1 line following treatment with the Hyper-CL™ lens + salt solution
assess by physiological parameter
Time frame: Up to 28 days (or 21 days if wash out is not needed).
Percent of subjects with corneal thickness decrease of at least 8%.
assess by physiological parameter
Time frame: Up to 28 days (or 21 days if wash out is not needed).
Percent of subjects with visual acuity improvement of at least 1 line
assess by physiological parameter
Time frame: Up to 28 days (or 21 days if wash out is not needed).
Corneal thickness decrease
assess by physiological parameter
Time frame: Up to 28 days (or 21 days if wash out is not needed).
change in Measurement Best Corrected Distance Visual Acuity (BCDVA)
Time frame: Up to 28 days (or 21 days if wash out is not needed).
change in Subject comfort questionnaire
Time frame: Up to 28 days (or 21 days if wash out is not needed).
Plan to share: Undecided
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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