Endothelial Bleb Response With Toric Lenses

NCT00630305 | Completed Results

• 2 other identifiers: CR-0726JJO0717
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state.

Conditions

Ametropia

Keywords

toric; endothelial bleb

Outcome Measures

Primary Outcomes (4)

• Endothelial Bleb Areas on Cornea: Session A- Open Eye

  Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.

  20 minutes post-lens insertion

• Endothelial Bleb Areas on Cornea: Session B- Closed Eye

  Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.

  20 minutes post-lens insertion

• Endothelial Bleb Areas on Cornea: Session C- Open Eye

  Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.

  20 minutes post-lens insertion

• Endothelial Bleb Areas on Cornea: Session D- Closed Eye

  Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.

  20 minutes post-lens insertion

Study Arms (4)

Session A

OTHER

Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session A only contains senofilcon A toric and alphafilcon A toric lenses.

Device: alphafilcon A toric; Device: senofilcon A toric

Session B

OTHER

Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session B only contains senofilcon A toric and alphafilcon A toric lenses.

Device: alphafilcon A toric; Device: senofilcon A toric

Session C

OTHER

Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session C only contains senofilcon A toric and lotrafilcon B toric lenses.

Device: lotrafilcon B toric; Device: senofilcon A toric

Session D

OTHER

Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session D only contains senofilcon A toric and lotrafilcon B toric lenses.

Device: lotrafilcon B toric; Device: senofilcon A toric

Interventions

alphafilcon A toric DEVICE

Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).

Session A; Session B

lotrafilcon B toric DEVICE

Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).

Session C; Session D

senofilcon A toric DEVICE

Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).

Session A; Session B; Session C; Session D

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
• At least 18 years of age and mentally competent to sign an informed consent form.
• Healthy eyes and no use of ocular medication.
• Similarity of optical parameters between eyes.
• Physical appearance typical of Asian eyes

You may not qualify if:

• A medical or ocular condition that may influence the outcome of this trial.
• Current use of ocular/systemic medication that may influence the outcome of this trial.
• Failure to wear soft lenses for 2 weeks prior to the start of the study.
• Current enrolment or participation in another clinical study.
• Current state of pregnancy or breastfeeding
• Anisometropia greater than 1.00D (equivalent sphere).
• Unequal acuities between eyes (greater than 1 line)
• Unequal corneal curvatures (\>1.00D)

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Brennan Consultants 110 Auburn Rd

Auburn Village, Victoria, 3122, Australia

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Kurt Moody, OD
• Organization: Johnson & Johnson Vision Care, Inc.

kmoody1@its.jnj.com

1-904-443-3088

Study Officials

• Noel A Brennan, McOptom PhD

  Brennan Consultants

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 3, 2017
• Results First Posted: March 3, 2017

Record last verified: 2017-01

Locations

AU (1)