NCT04040790 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Compañ V, Oliveira C, Aguilella-Arzo M, Mollá S, Peixoto-de-Matos SC, González-Méijome JM
Oxygen diffusion and edema with modern scleral rigid gas permeable contact lenses. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6421-9. doi: 10.1167/iovs.14-14038.
Eyeson-Annan ML, Hirst LW, Battistutta D, Green A
Comparative pupil dilation using phenylephrine alone or in combination with tropicamide. Ophthalmology. 1998 Apr;105(4):726-32.
García-Lázaro S, Ferrer-Blasco T, Radhakrishnan H, Cerviño A, Charman WN, Montés-Micó R
Visual function through 4 contact lens-based pinhole systems for presbyopia. J Cataract Refract Surg. 2012 May;38(5):858-65. doi: 10.1016/j.jcrs.2011.11.042. Epub 2012 Mar 16.
Holden BA, Mertz GW
Critical oxygen levels to avoid corneal edema for daily and extended wear contact lenses. Invest Ophthalmol Vis Sci. 1984 Oct;25(10):1161-7.
Pepose JS
Small-aperture contact lenses for presbyopia. J Cataract Refract Surg. 2012 Nov;38(11):2060-1; author reply 2062-4. doi: 10.1016/j.jcrs.2012.08.041.
Xu R, Gil D, Dibas M, Hare W, Bradley A
The Effect of Light Level and Small Pupils on Presbyopic Reading Performance. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5656-5664. doi: 10.1167/iovs.16-20008.

Evaluation of Light Sensitivity and Visual Acuity Changes as Consequence of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris

Details for clinical trial NCT04040790

Clinical trial NCT04040790 - References