---
title: Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
nct_id: NCT02185105
overall_status: COMPLETED
phase: NA
sponsor: CooperVision, Inc.
study_type: INTERVENTIONAL
primary_condition: Myopia
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02185105.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02185105"
ct_last_update_post_date: 2017-03-07
last_seen_at: "2026-05-12T06:21:49.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

**NCT ID:** [NCT02185105](https://clinicaltrials.gov/study/NCT02185105)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** CooperVision, Inc.
- **Conditions:** Myopia, Astigmatism
- **Start Date:** 2014-06
- **Completion Date:** 2014-06
- **CT.gov Last Update:** 2017-03-07

## Brief Summary

The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

## Detailed Description

Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Has had a self-reported oculo-visual examination in the last two years.
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Currently wears soft contact lenses.
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination

Exclusion Criteria:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
```

## Arms

- **comfilcon A MTO** (EXPERIMENTAL) — Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
- **comfilcon A** (ACTIVE_COMPARATOR) — Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.

## Interventions

- **comfilcon A MTO** (DEVICE) — Randomized to a test lens in one eye and control lens in the other as a matched pair.
- **comfilcon A** (DEVICE) — Randomized to a test lens in one eye and control lens in the other as a matched pair.

## Primary Outcomes

- **Lens Surface Assessment of Study Lenses - Surface Wettability** _(time frame: 15min & 6hrs)_ — Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)
- **Lens Surface Assessment of Study Lenses - Deposits** _(time frame: 15min & 6hrs)_ — Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film \> 75% of surface)
- **Lens Surface Assessment of Study Lenses - Surface Acceptance** _(time frame: 15min & 6hrs)_ — Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)
- **Subjective Rating For Comfort - Comfort Since Last Visit** _(time frame: 15min, 3hrs, 6hrs)_ — Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)
- **Subjective Rating For Comfort Preference** _(time frame: 1min, 15min, 3hrs, 6hrs)_ — Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
- **Subjective Rating For Handling - Insertion** _(time frame: 1 min)_ — Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)
- **Subjective Rating For Handling - Removal** _(time frame: 1 min)_ — Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)
- **Investigator's Assessment of Stability** _(time frame: 15min & 6hrs)_ — Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
- **General Lens Fit - Fit Acceptance** _(time frame: 15min & 6hrs)_ — Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
- **Lens Fitting - Rotation/Mislocation** _(time frame: Baseline, 15min & 6hrs)_ — Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).
- **Anterior Ocular Health - Corneal Staining (Central)** _(time frame: baseline & 6hrs)_ — Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
- **Anterior Ocular Health - Corneal Staining (Nasal)** _(time frame: baseline & 6hrs)_ — Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
- **Anterior Ocular Health - Corneal Staining (Temporal)** _(time frame: baseline & 6hrs)_ — Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
- **Anterior Ocular Health - CornealStaining (Superior)** _(time frame: baseline & 6hrs)_ — Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
- **Anterior Ocular Health - Corneal Staining (Inferior)** _(time frame: baseline & 6hrs)_ — Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
- **Anterior Ocular Health - Conjunctival Staining (Nasal)** _(time frame: baseline & 6hrs)_ — Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
- **Anterior Ocular Health - Conjunctival Staining (Superior)** _(time frame: baseline & 6hrs)_ — Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
- **Anterior Ocular Health - Conjunctival Staining (Temporal)** _(time frame: baseline & 6hrs)_ — Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
- **Anterior Ocular Health - Conjunctival Staining (Inferior)** _(time frame: baseline & 6hrs)_ — Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

## Locations (1)

- CORL, Indiana University, Bloomington, Indiana, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.corl, indiana university|bloomington|indiana|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02185105.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02185105*  
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