N/A Completed N=60 Single-blind Other

Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses

Astigmatism

Source: ClinicalTrials.gov NCT02142361 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcomePrimary: Participant's Subjective Rating for Lens Initial Comfort — 6.9; 7.4; 8.0; 8.9 units on a scale

Summary

Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.

Outcome Measures

Outcome	Result	p-value
PRIMARY Participant's Subjective Rating for Lens Initial Comfort	6.9; 7.4; 8.0; 8.9; 7.8; 8.1	—
PRIMARY Participant's Subjective Rating for Lens Comfort Prior to Removal	7.4; 7.4; 6.7; 8.2; 8.0; 7.3	—
PRIMARY Participant's Subjective Rating for Overall Lens Comfort	8.2; 8.4; 8.2; 8.8; 8.4; 8.4	—
PRIMARY Participant's Subjective Rating for Dryness During the Day	7.7; 8.0; 7.4; 8.6; 8.1; 8.2	—
PRIMARY Participant's Subjective Rating for Dryness Prior to Removal	7.4; 7.0; 6.3; 7.7; 7.5; 7.5	—
PRIMARY Participant's Subjective Rating for Overall Dryness	7.8; 7.6; 7.2; 8.8; 8.3; 8.2	—
PRIMARY Participant's Subjective Rating for Lens Handling - Insertion	8.4; 8.8; 9.1; 9.3; 8.8; 9.5	—
PRIMARY Participant's Subjective Rating for Overall Lens Fit Stability	8.1; 7.8; 7.9; 8.1; 8.0; 9.0	—
PRIMARY Participant's Subjective Rating for Overall Vision Satisfaction	8.3; 8.1; 8.6; 8.6; 8.7; 9.3	—
PRIMARY Participant's Subjective Rating for Vision Quality at Insertion	77; 75.5; 79.5; 87.5; 82.5; 86.5	—
PRIMARY Participant's Subjective Rating for Vision Quality During the Day	83; 86; 84.5; 87.5; 85; 91.5	—
PRIMARY Participant's Subjective Rating for Vision Quality End of the Day	79; 82.5; 76; 79.8; 80.5; 87.5	—
PRIMARY Participant's Subjective Rating for Night Vision Quality	77.3; 83.3; 81.8; 83.5; 84.5; 87.3	—
PRIMARY Participant's Subjective Rating for Vision Stability at Insertion	74; 70; 71.5; 86.5; 81; 85.5	—
PRIMARY Participant's Subjective Rating for Vision Stability During the Day	83; 81.5; 77.5; 82.5; 82.5; 90	—
PRIMARY Participant's Subjective Rating for Vision Stability at End of Day	81; 79.5; 75.5; 77.5; 82; 88.5	—
PRIMARY Participant's Subjective Rating for Lens Pair Preference	10; 90; 13; 87; 25; 75	—
PRIMARY Participant's Subjective Rating for Overall Satisfaction - Dryness	27; 40; 55; 42; 18; 13	—
PRIMARY Participant's Subjective Rating for Overall Satisfaction - Handling	73; 87; 23; 12; 3; 2	—
PRIMARY Participant's Subjective Rating for Overall Satisfaction - Vision	48; 62; 43; 37; 8; 0	—
PRIMARY Participant's Subjective Rating for Overall Satisfaction - Lens Fit	40; 65; 42; 23; 18; 12	—
PRIMARY Participant's Subjective Rating for Overall Satisfaction - Overall	30; 58; 67; 42; 3; 0	—
PRIMARY Clinician's Objective Assessment Monocular High Contrast Distance Visual	-0.037; -0.037; -0.037; -0.037	—
PRIMARY Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity	-0.037; -0.037	—
PRIMARY Clinician's Assessment Overall Lens Stability-Right Eye	0; 0; 0; 0; 0; 0	—
PRIMARY Clinician's Assessment Overall Lens Stability-Left Eye	0; 0; 0; 0; 0; 0	—
PRIMARY Clinician's Assessment Overall Fit Acceptance- Right Eye	0; 0; 0; 0; 0; 0	—
PRIMARY Clinician's Assessment Overall Fit Acceptance- Left Eye	0; 0; 0; 0; 0; 0	—
PRIMARY Clinician's Assessment Lens Centration-Right Eye	100; 100; 0; 0; 0; 0	—
PRIMARY Clinician's Assessment Lens Centration- Left Eye	100; 100; 0; 0; 0; 0	—
PRIMARY Clinician's Assessment Corneal Coverage-Right Eye	100; 100; 0; 0	—
PRIMARY Clinicians Assessment Corneal Coverage-Left Eye	100; 100; 0; 0	—
PRIMARY Clinician's Assessment Post-Blink Movement- Right Eye	0; 0; 0; 0; 100; 100	—
PRIMARY Clinician's Assessment Post-Blink Movement-Left Eye	0; 0; 0; 0; 100; 100	—
PRIMARY Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye	12; 0; 18; 100; 70; 0	—
PRIMARY Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye	12; 0; 73; 100; 15; 0	—
PRIMARY Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye	0; 0	—
PRIMARY Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye	0; 0	—
PRIMARY Participant's Subjective Rating for Overall Satisfaction - Comfort	30; 55; 58; 40; 12; 5	—

Eligibility Criteria

Inclusion Criteria

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted soft toric contact lens wearer
Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)
Have no less than 0.75D of astigmatism and no more than 1.75 D in both eyes.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Patient contact lens refraction should fit within the available parameters of the study lenses.
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule

Exclusion Criteria

Has a contact lens prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder less than -0.75D or more than -1.75D of cylinder in either eye.
Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings
Pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (past or present)
Seborrheic eczema, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02142361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.